Spreadsheet: 81821d1281976775-macro-to-compare-entire-row-in-new_sheet-xls-old_sheet
Sheet: old sheet

2010-07-26 00:00:00
01-CMAX - World
Subject | Folder | Form | Field | Log # | [NAME] | Qry Open Date | Qry Open By | Query Text | Marking Gr. Name | [NAME] | Response Text | [NAME] By | [NAME] | [NAME] | Comments
0001 0013 | 12h | PK [NAME] | PUETM | 0 | Answered | Jul  6 2010  2:46AM | N.Kumari | Thanks for the repsonse. End time is not 12 hours from Start time of infusion. Please correct or clarify. | Site from DM | Jul  7 2010  4:09AM | 16:20:00 | S.Wittmann |  |  | Get clarified from Deepa
0001 0026 | Local Tolerability Assessment | Swelling | LTSTTM | 0 | Answered | Jun 28 2010  1:36PM | D.Raghavendra | Start Time does not match timepoint of first 'Yes' recorded. Please correct or clarify. | Site from DM | Jul 12 2010  1:08AM | AE check was performed 12 hour post dose, swelling commenced at 1941 as per source book | S.Wittmann |  |  | Updated in ADL
0001 0033 | Local Tolerability Assessment | Redness | LTSTTM | 0 | Answered | Jun 28 2010  1:25PM | D.Raghavendra | Start Time is not in line with timepoint of first 'Yes' recorded. Please correct or clarify. | Site from DM | Jul  9 2010  1:14AM | AE check was performed at 11:56 prior to urine sample,no window in protocol | S.Wittmann |  |  | Updated in ADL
0001 0013 | Pre-dose | 12-Lead ECG | EGTM1 | 3 | Answered | Jun 29 2010  2:40AM | System | Data is required.  Please complete. | Site from System | Jul  1 2010  1:59AM | awaiting ERT result | S.Wittmann |  |  | Awaiting ERT result
0001 0026 | 24h | Blood Sample Collection | BDCOD | 9 | Answered | Jul  7 2010  1:02AM | N.Kumari | Thanks for the response.Please record the response given in subject identification number field. | Site from DM | Jul  7 2010  4:45AM | cannot open field to enter identification number 1097850 | S.Wittmann |  |  | Uneditable field
0001 0003 | Pre-dose | Blood Sample Collection | BDCOD | 9 | Answered | Jul  9 2010 12:57AM | N.Kumari | Thanks for the response. Please record the response given in the sample identification number field. | Site from DM | Jul 16 2010  1:01AM | cannot unlock field to enter data | S.Wittmann |  |  | Uneditable field
0001 0003 | 8h | Blood Sample Collection | BDTTM | 0 | Answered | Jun 29 2010  4:38AM | System | Time is not 8 h (+-2 min) from Start time of infusion | Site from System | Jul  5 2010  1:57AM | d | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0026 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010 12:01AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  1:24AM | dat is correct | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0007 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul  5 2010  3:05AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul  5 2010  3:06AM | data correct | E.King | 2010-07-27 00:00:00 | NK | Resolved
0001 0033 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  1:53AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  1:53AM | Data correct window not specified in Protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0013 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 29 2010  2:46AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  1 2010  2:21AM | data correct, 2 min window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0013 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  1:27AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:21AM | data correct, 2 min window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0003 | 36h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  4:56AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:14AM | data correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  6:04AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:06AM | data correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0006 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:21AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:45AM | data correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0013 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  1:26AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:20AM | data correct, 2 window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0017 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  6:57AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  6:58AM | data correct, no window in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0014 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010 11:50PM | System | Time is not 36 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010 11:51PM | Data Correct. Outside window due to human error | J.Gorman | 2010-07-28 00:00:00 | NK | Resolved
0001 0014 | 30h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010 11:47PM | System | Time is not 30 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010 11:48PM | Data correct. outside window due toStaff error | J.Gorman | 2010-07-28 00:00:00 | NK | Resolved
0001 0014 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010 11:17PM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010 11:18PM | Data correct. Sample collected outside window due to human error | J.Gorman | 2010-07-28 00:00:00 | NK | Resolved
0001 0014 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010 10:53PM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010 10:54PM | Data correct. Time window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0011 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 30 2010  1:41AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  5:54AM | Data correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0033 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  2:25AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  2:26AM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010 11:19PM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010 11:20PM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010 11:45PM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010 11:45PM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0033 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  2:42AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  2:42AM | Data correct. window not in protocol | J.Gorman | 2010-07-27 00:00:00 | M | Resolved
0001 0011 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  2:15AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:03AM | Data correct. WIndow not in Protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0026 | 24h | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  1:09AM | N.Kumari | Thanks for the response. As per response data correct, "Time is not 24 h (+-2 min) from Start time of infusion". Please correct. | Site from DM | Jul  2 2010  5:20AM | Data correct. Window not in protocol | J.Gorman |  |  | Check not changed during migration
0001 0033 | 36h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  2:46AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  2:46AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010 11:52PM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010 11:53PM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0033 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  2:06AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  2:11AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0033 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  2:18AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  2:18AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010 11:02PM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010 11:02PM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 18 2010 11:50PM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 18 2010 11:50PM | data correct. window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010  6:09AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:09AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0033 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  3:15AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  3:15AM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010 12:19AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010 12:19AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0014 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  1:12AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  1:12AM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0033 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  3:18AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  3:18AM | Data correct. window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  1:41AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  1:41AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  5:07AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  5:08AM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  7:00AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  7:01AM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  1:49AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  1:49AM | Data correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010 11:15PM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010 11:15PM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0033 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  2:24AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  2:24AM | Data Correct. Window not in Protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0011 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  1:34AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:51AM | Data correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0033 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  2:40AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  2:41AM | Data Correct. window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010 11:31PM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010 11:32PM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0011 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  1:37AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:54AM | Data correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0033 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  1:59AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  1:59AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0033 | 36h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  2:44AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  2:44AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0011 | 36h | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  4:43AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:03AM | Data correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0014 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010 11:48PM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010 11:49PM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0033 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  2:04AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  2:04AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0033 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  2:13AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  2:13AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0011 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  1:54AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:58AM | Data correct. window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  1:56AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:59AM | Data correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0033 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  2:15AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  2:15AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010 10:57PM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010 10:58PM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 18 2010 11:48PM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 18 2010 11:49PM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0014 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:15AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:16AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0014 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:23AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:23AM | Data correct. window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0033 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  3:16AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  3:16AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0014 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  1:19AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  1:20AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  1:47AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  1:48AM | Data Correct. Window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  7:00AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  7:00AM | Data correct. window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0011 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul  1 2010 12:24AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  5:59AM | Data correct.window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  2:13AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:03AM | Data Correct.Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0017 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  5:04AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  5:04AM | Data correct.window not in protocol | J.Gorman | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 28 2010  1:06AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jun 28 2010  1:07AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 28 2010  1:23AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jun 28 2010  1:23AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  1:11AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  1:11AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  1:25AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  1:25AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010 12:47AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010 12:50AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  1:04AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  1:04AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  1:09AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  1:09AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  1:19AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  1:19AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  1:20AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  1:20AM | data correct; window not specified in protocol | E.King | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | Local Tolerability Assessment | Redness | LTSPTM | 0 | Answered | Jul  7 2010  2:23AM | N.Kumari | Stop Time is not in line with the timepoint of last 'Yes' recorded. Please correct or clarify. | Site from DM | Jul  7 2010  4:17AM | data corrected | S.Wittmann |  |  | As per souce
0001 0013 | Local Tolerability Assessment | Redness | LTSTTM | 0 | Answered | Jul  7 2010  2:16AM | N.Kumari | Start Time is not in line with timepoint of first 'Yes' recorded. Please correct or clarify. | Site from DM | Jul  7 2010  4:17AM | data corrected | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0026 | 12h | PK [NAME] | PUSTM | 0 | Answered | Jul  1 2010 12:47AM | System | Start time is not within one minute from the end time of the previous 4 hours collection period. Please correct or clarify. | Site from System | Jul  1 2010 12:48AM | data corrected | S.Wittmann |  |  | exactly 4 hours
0001 0033 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010 12:43AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  6 2010  1:20AM | data corrected | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:42AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:42AM | data corrected, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0033 | Local Tolerability Assessment | Redness | LTSPTM | 0 | Answered | Jun 25 2010  8:45AM | System | Redness Present? is Yes, however, Stop time is missing. Please provide. | Site from System | Jul  9 2010 12:35AM | data entered | S.Wittmann |  |  | Updated in ADL
0001 0041 | 8h | PK [NAME] | PUSTM | 0 | Answered | Jun 30 2010  5:38AM | System | Start time is not within one minute from the end time of the previous 4 hours collection period. Please correct or clarify. | Site from System | Jul  1 2010  6:02AM | data error | T.Mischin |  |  | Get clarified from Deepa, start time 16:00 end time 20:00.
0001 0041 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jun 30 2010  4:48AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jun 30 2010  4:49AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0006 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jun 30 2010  2:47AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jun 30 2010  2:48AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0011 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jun 30 2010 12:56AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jun 30 2010 12:57AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0033 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jun 28 2010  1:16AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jun 30 2010  6:25AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0003 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jun 29 2010  4:00AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jun 29 2010  4:01AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jun 29 2010 12:27AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jun 29 2010 12:28AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 14 2010  1:00AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 14 2010  1:49AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 14 2010  3:06AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 14 2010  3:07AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 14 2010  4:42AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 15 2010 12:01AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 15 2010  2:02AM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jul 15 2010  2:02AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jul  1 2010  1:06AM | System | Time is not 36 h (+-2 min) from Start time of infusion | Site from System | Jul  1 2010  1:07AM | data is correct | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0041 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jun 30 2010  5:57AM | System | Time is not 36 h (+-2 min) from Start time of infusion | Site from System | Jul  5 2010  5:56AM | data is correct | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0006 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 30 2010  3:14AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  4:40AM | data is correct | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | 0h | Pharmacy | PHALOT | 0 | Answered | Jul 12 2010  1:38AM | N.Kumari | Thanks for the response.However, Lot number does not start with 'CTSLHDL0963-'. Please correct. | Site from DM | Jul 16 2010  1:03AM | data is correct | S.Wittmann |  |  | Referred to CSL for confirmation
0001 0013 | 12h | PK [NAME] | PUSTM | 0 | Answered | Jul  1 2010  2:33AM | System | Start time is not within one minute from the end time of the previous 4 hours collection period. Please correct or clarify. | Site from System | Jul  1 2010  2:35AM | data is correct | S.Wittmann |  |  | Get clarified from Deepa
0001 0041 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  5:47AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:55AM | data is correct | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0029 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  4:56AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  4:57AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | 36h | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  1:14AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  1:15AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 28 2010 11:57PM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  1:25AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010 12:04AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  1:27AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010 12:25AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  1:31AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 36h | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  1:00AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  1:00AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0041 | 36h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:54AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:56AM | data is correct | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0006 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:16AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:41AM | data is correct | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0028 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  3:31AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  3:31AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 28 2010 11:55PM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  1:18AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 28 2010 11:59PM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  1:24AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010 12:02AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  1:26AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010 12:24AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  1:27AM | data is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  3:02AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  3:02AM | data is correct 2 min window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0026 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010 12:31AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010 12:31AM | data is correct 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  1:17AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:15AM | data is correct no window in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0013 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  1:15AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:18AM | data is correct no window in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:33AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:56AM | data is correct,  2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0013 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 29 2010  2:43AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  1 2010  2:36AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0013 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  1:40AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:32AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  1:57AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:40AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | 36h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  2:01AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:43AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  1:29AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:24AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  2:04AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:47AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  2:07AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:50AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  2:08AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  1 2010  2:52AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  1:05AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:37AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  1:55AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:40AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  1:08AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:36AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0013 | 36h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  1:59AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:42AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  2:03AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:44AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  2:05AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:47AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  2:09AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:51AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0013 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  2:52AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  1 2010  2:53AM | data is correct, 2 min window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0005 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:21AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:24AM | data is correct, 2 minute window is | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0006 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jun 30 2010  3:31AM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jul  5 2010  4:49AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0028 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 12 2010  4:37AM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jul 12 2010  4:38AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0028 | 18h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 12 2010  4:41AM | System | Time is not 18 h (+-2 min) from Start time of infusion | Site from System | Jul 12 2010  4:42AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0005 | 18h | Blood Sample Collection | BDTTM | 0 | Answered | Jun 29 2010  5:57AM | System | Time is not 18 h (+-2 min) from Start time of infusion | Site from System | Jul  5 2010  3:10AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0014 | 2h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 12 2010  5:28AM | System | Time is not 2 h (+-2 min) from Start time of infusion | Site from System | Jul 12 2010  5:29AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0028 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 12 2010  4:51AM | System | Time is not 36 h (+-2 min) from Start time of infusion | Site from System | Jul 12 2010  4:51AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0028 | 3h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 12 2010  3:18AM | System | Time is not 3 h (+-2 min) from Start time of infusion | Site from System | Jul 12 2010  3:18AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0041 | Day 6 (120h) | Blood Sample Collection | BDTTM | 0 | Answered | Jun 30 2010  6:04AM | System | Time is not 120 h (+-2 min) from Start time of infusion | Site from System | Jul  5 2010  6:06AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0041 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 30 2010  5:17AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  5:40AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0033 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul  6 2010 12:48AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  6 2010 12:49AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0005 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 29 2010  6:27AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  2:55AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 29 2010  6:44AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  1:11AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 29 2010  4:21AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  1:50AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 29 2010  4:35AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  2:03AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 30 2010  1:05AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  1:16AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 29 2010  6:30AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  3:10AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0033 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jun 28 2010  2:16AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  6 2010  1:00AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0006 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul  1 2010 12:27AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  4:47AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul  1 2010 12:16AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul  5 2010  5:45AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0041 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  5:42AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:49AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0006 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:32AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:49AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  5:54AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:05AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  4:43AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:04AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0028 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  4:38AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  4:39AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0003 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  4:53AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:12AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:18AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0006 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:39AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:52AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | 24h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:06AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:13AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 36h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:14AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:15AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0006 | 36h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:42AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:54AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | 36h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  5:58AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:57AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0011 | 36h | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  4:45AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010 11:56PM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | 36h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:19AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  5:42AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:57AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  4:28AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:52AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:14AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  5:23AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:43AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0006 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:19AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:42AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0028 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  2:26AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  2:26AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0028 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  4:25AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  4:25AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0006 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:25AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:47AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  5:35AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:46AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0002 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:15AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  4:39AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:00AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  5:49AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:03AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0013 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010 12:45AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010 12:46AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0002 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010  1:28AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:28AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010  2:39AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:39AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010  3:33AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:33AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0041 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010  6:13AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:14AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0006 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  5 2010  4:19AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:20AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0033 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul  6 2010  1:42AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul  6 2010  1:42AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0041 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  6:00AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:03AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0006 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:44AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:56AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  2:18AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010 11:58PM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:16AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:19AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:20AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  5:01AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:15AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0028 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  4:58AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  4:58AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  5:04AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  5:04AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0003 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  5:04AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:24AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:21AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:19AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:21AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  2:22AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  6 2010 12:01AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0006 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:46AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  4:59AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  6:02AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:05AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0033 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  6:29AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  6 2010  1:14AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0006 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  3:48AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:00AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  2:25AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  6 2010 12:02AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:46AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:22AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  5:07AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:25AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  2:38AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  1:23AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  5:26AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  2:32AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  4:39AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  6 2010 12:03AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0033 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010 12:45AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  6 2010  1:21AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0006 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  5:52AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:01AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  4:46AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:07AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0005 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul  1 2010  5:31AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  3:26AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0017 | 0.5h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:04AM | System | Time is not 0.5 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:04AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0028 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  4:36AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  4:37AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0041 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:41AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:49AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0006 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:31AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:48AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  5:53AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:05AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:41AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:03AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  5:34AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:52AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:17AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:45AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:10AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0006 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:07AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:35AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0041 | 1h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:12AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:31AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0028 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  2:21AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  2:21AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:07AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:07AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  4:44AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  4:44AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0041 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:47AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:54AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0006 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:38AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:51AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:04AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:11AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:18AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | 24h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:51AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:07AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  5:37AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:53AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:19AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:48AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:10AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0006 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:10AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:38AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | 2h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:15AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:39AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0014 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  5:26AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  5:27AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0028 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  2:23AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  2:23AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0006 | 36h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:41AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:53AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | 36h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:08AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:15AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | 36h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:19AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | 36h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:55AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:13AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0005 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  5:41AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:56AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:27AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:52AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:12AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0014 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  5:31AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  5:31AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0041 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:22AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:42AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0028 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  2:25AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  2:25AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  3:29AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  3:29AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0041 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:33AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:44AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0002 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:14AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:31AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:55AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | 6h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  5:46AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:00AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:15AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0041 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:34AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:45AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0006 | 8h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:23AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:46AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0006 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010  4:15AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:16AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010  3:28AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:28AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0033 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  6 2010  1:22AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  6 2010  1:22AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0041 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010  6:09AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:09AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0026 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010 12:26AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010 12:40AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010 12:43AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010 12:43AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0003 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010  2:34AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:34AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010  1:24AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:24AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:19AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0003 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  4:59AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:15AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0041 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  5:59AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:59AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0006 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:43AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:54AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  2:17AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010 11:56PM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:15AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:19AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0028 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  4:54AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  4:54AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  5:00AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  5:00AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0005 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:17AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:21AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  2:19AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010 11:59PM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0006 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:45AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:56AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0041 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  6:01AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:03AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0003 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  5:03AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:22AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:21AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0002 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:45AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:21AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  5:05AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:25AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0041 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  6:03AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:05AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0033 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  6:28AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  6 2010  1:12AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0006 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  3:47AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  4:59AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  2:23AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  6 2010 12:01AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:20AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:24AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  4:28AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  6 2010 12:03AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0041 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  4:44AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:07AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0006 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  5:47AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:01AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  5:28AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  3:26AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0002 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jun 30 2010 11:56PM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  1:23AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0003 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  5:14AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  2:32AM | data is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0028 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  4:49AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  4:49AM | data is correct, 2 window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0033 | Local Tolerability Assessment | Redness | LTSTTM | 0 | Answered | Jun 28 2010  1:41AM | System | Start time is before Start time of infusion. Please correct. | Site from System | Jul  9 2010  1:14AM | data is correct, as cannulation was performed at 07:06 24 Jun 2010 | S.Wittmann |  |  | Get clarified from Deepa 24-Jun dosing, 25-Jun is the Date of AE
0001 0017 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 12 2010  6:43AM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jul 12 2010  6:43AM | data is correct, no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0017 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  6:44AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  6:44AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0017 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  6:50AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  6:50AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  4:47AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  4:47AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  6:53AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  6:53AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0017 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  6:28AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  6:28AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0017 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  6:38AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  6:38AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0017 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  7:02AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  7:02AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:48AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:49AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0017 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:52AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:52AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:25AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:25AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:31AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:31AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:34AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:35AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:55AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:55AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  7:00AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  7:00AM | data is correct, no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0017 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010  6:20AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010  6:21AM | data is correct, no windows in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0028 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  4:51AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  4:52AM | data is correct, window not in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0014 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 12 2010  5:34AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 12 2010  5:35AM | data is correct, window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  1:09AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  1:09AM | data is correct, window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0011 | 4h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  1:46AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:56AM | Data is correct. Time window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  2:07AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:01AM | Data is correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | 4h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  1:48AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  5:57AM | Data is correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | 8h | [NAME] | UDSTM | 0 | Answered | Jun 30 2010  1:57AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul  5 2010  6:00AM | Data is correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | 0.5h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  1:34AM | System | Time is not 0.5 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  5:50AM | Data is correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Queried
0001 0011 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 30 2010  2:06AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:01AM | Data is correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0011 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul  5 2010  6:05AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul  5 2010  6:05AM | Data is correct. Window not in protocol | J.Gorman | 2010-07-26 00:00:00 | NK | Resolved
0001 0026 | 24h | Vital Signs | VSTM | 0 | Answered | Jul  1 2010  1:15AM | N.Kumari | Thanks for the response. As per response data correct, "Time is not 24 h (+-2 min) from Start time of infusion".Please correct. | Site from DM | Jul  2 2010  5:19AM | Data is correct.indow not in protocol. | J.Gorman | 2010-07-28 00:00:00 | NK | Resolved
0001 0014 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul  9 2010  6:18AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 11 2010 11:45PM | date is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 12 2010  3:04AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 12 2010  3:05AM | date is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 14 2010  8:23AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 15 2010  4:10AM | date is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 15 2010  1:00AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 15 2010  1:01AM | date is correct | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0005 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jun 29 2010 12:56AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jun 29 2010 12:57AM | Date is the same as date of visit, confirmed correct. | K.Beard | 2010-07-27 00:00:00 | NK | Resolved
0001 0014 | Screening (Day -28  to -2) | Visit Date | VISDT | 0 | Answered | Jul 12 2010 12:08AM | System | Date of visit is not between Day -28 and Day -2 from the date of infusion. Please correct. | Site from System | Jul 12 2010  5:18AM | date of visit should be 08 July 2010, June was entered in error, this field has been locked | S.Wittmann |  |  | uneditable field
0001 0017 | Admission (Day -1) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 12 2010  5:55AM | System | Date of collection is not same as date of visit. Please correct or clarify. | Site from System | Jul 15 2010  5:00AM | Day -1 is 07 Jul 2010. Collection date is correct | J.Gorman | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | 12h | PK [NAME] | PUSDT | 0 | Answered | Jul 15 2010  4:49AM | System | Date is not the same as Date of visit. Please correct or clarify. | Site from System | Jul 15 2010  4:51AM | dosing date is 08 Jul 10 at 12:30 - 12 hours post = 09 Jul 10 | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0005 | Day 15 (Follow-up) | 12-Lead ECG | EGTM1 | 2 | Answered | Jul 16 2010  1:47AM | System | Time of second ECG is not 2-5 minutes after time of first ECG. Please correct or clarify. | Site from System | Jul 16 2010  1:49AM | ECG was repeated due to reversed arm leads | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0026 | Local Tolerability Assessment | Swelling | LTSPTM | 0 | Answered | Jun 28 2010  2:13PM | D.Raghavendra | Stop Time is not in line with the timepoint of last 'Yes' recorded. Please correct or clarify. | Site from DM | Jul 12 2010  1:08AM | end time for AE is correct as per source book | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0014 | Screening (Day -28  to -2) | Alcohol Breath Test | ALDT | 0 | Answered | Jul 12 2010 12:08AM | System | Date of Alcohol Breath test is not between Day -28 and Day -2 from the date of infusion. Please correct. | Site from System | Jul 12 2010  5:20AM | field has been locked, correct date should be 08 July 2010 | S.Wittmann |  |  | uneditable field
0001 0014 | Screening (Day -28  to -2) | Blood Sample Collection | BDTDT | 0 | Answered | Jul 12 2010 12:08AM | System | Date of collection is not between Day -28 and Day -2 from the date of infusion. Please correct. | Site from System | Jul 12 2010  5:19AM | field has been locked, correct date should be 08 July 2010 | S.Wittmann |  |  | uneditable field
0001 0014 | Screening (Day -28  to -2) | Pregnancy and Hormone Testing | PRHDT | 0 | Answered | Jul 12 2010 12:08AM | System | Date of Urine Pregnancy test is not between Day -28 and Day -2 from the date of infusion. Please correct. | Site from System | Jul 12 2010  5:19AM | field has been locked, correct date should be 08 July 2010 | S.Wittmann |  |  | uneditable field
0001 0014 | Screening (Day -28  to -2) | [NAME] | UDSDT | 0 | Answered | Jul 12 2010 12:08AM | System | Date of collection is not between Day -28 and Day -2 from the date of infusion. Please correct. | Site from System | Jul 12 2010  5:19AM | field has been locked, correct date should be 08 July 2010 | S.Wittmann |  |  | uneditable field
0001 0014 | Screening (Day -28  to -2) | [NAME] – Drugs of Abuse | UIRDT | 0 | Answered | Jul 12 2010 12:08AM | System | Date of Urine sample collection is not between Day -28 and Day -2 from the date of infusion. Please correct. | Site from System | Jul 12 2010  5:20AM | field has been locked, correct date should be 08 July 2010 | S.Wittmann |  |  | uneditable field
0001 0033 | 0h | Study Product Administration | SPISTTM | 2 | Answered | Jun 28 2010  1:51AM | System | Yes is selected, however, further information on the interruption is not provided. Please correct. | Site from System | Jul  2 2010  5:20AM | Further interruption is not able to be entered.  eCRF shows error message when attempting to do so. | K.Beard |  |  | Get clarified from Deepa
0001 0014 | 6h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010 10:55PM | System | Time is not 6 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010 10:56PM | Late PK due to Human Error | J.Gorman | 2010-07-28 00:00:00 | NK | Resolved
0001 0002 | 8h | 12-Lead ECG | EGTM1 | 3 | Answered | Jun 30 2010  1:05AM | System | Data is required.  Please complete. | Site from System | Jul 16 2010 12:43AM | no ERT results | S.Wittmann |  |  | Get clarified from Deepa
0001 0022 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010  5:17AM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010  5:18AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0019 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010  3:47AM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010  3:47AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 18h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010  1:48AM | System | Time is not 18 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010  1:48AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0019 | 24h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010  3:53AM | System | Time is not 24 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010  3:53AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0029 | 30h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 15 2010  4:58AM | System | Time is not 30 h (+-2 min) from Start time of infusion | Site from System | Jul 15 2010  4:58AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0023 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 15 2010  2:15AM | System | Time is not 36 h (+-2 min) from Start time of infusion | Site from System | Jul 15 2010  2:15AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0023 | 4h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 15 2010  1:39AM | System | Time is not 4 h (+-2 min) from Start time of infusion | Site from System | Jul 15 2010  1:39AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | Day 11 (240h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 18 2010 11:50PM | System | Time is not 240 h (+-2 min) from Start time of infusion | Site from System | Jul 20 2010  1:16AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0028 | Day 11 (240h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 20 2010  1:49AM | System | Time is not 240 h (+-2 min) from Start time of infusion | Site from System | Jul 20 2010  1:49AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0028 | Day 3 (48h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010  2:20AM | System | Time is not 48 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010  2:20AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0028 | Day 6 (120h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 14 2010  2:24AM | System | Time is not 120 h (+-2 min) from Start time of infusion | Site from System | Jul 14 2010  2:25AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0022 | Day 6 (120h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 15 2010 12:24AM | System | Time is not 120 h (+-2 min) from Start time of infusion | Site from System | Jul 15 2010 12:25AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0022 | Day 8 (168h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 15 2010  6:11AM | System | Time is not 168 h (+-2 min) from Start time of infusion | Site from System | Jul 15 2010  6:11AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0028 | Day 8 (168h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 15 2010  5:37AM | System | Time is not 168 h (+-2 min) from Start time of infusion | Site from System | Jul 15 2010  5:37AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0023 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 15 2010  1:24AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 15 2010  1:32AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 15 2010  1:24AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 15 2010  6:22AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  2:03AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  2:03AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  4:48AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  4:48AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  3:47AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  3:47AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  5:18AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  5:18AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  1:44AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  1:44AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0002 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jul 16 2010 12:44AM | no window in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Queried
0001 0035 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  2:03AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  2:03AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0019 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  3:54AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  3:55AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010 12:09AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010 12:09AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  2:10AM | System | Time is not 24 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  2:10AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  2:15AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  2:15AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  5:00AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  5:01AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010 12:12AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010 12:13AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  3:57AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  3:57AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  2:06AM | System | Time is not 36 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  2:06AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0035 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  1:19AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  1:19AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  5:06AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  5:06AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  3:34AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  3:34AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  1:40AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  1:40AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  1:46AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  1:46AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  4:41AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  4:41AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  3:42AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  3:42AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  5:12AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  5:12AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  1:26AM | System | Time is not 8 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  1:26AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0017 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 20 2010  2:49AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 20 2010  2:49AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 20 2010  3:46AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 20 2010  3:46AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0019 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 20 2010  4:12AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 20 2010  4:12AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 20 2010  4:33AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 20 2010  4:34AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 20 2010  5:01AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 20 2010  5:01AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 19 2010  1:04AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 20 2010  1:46AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 20 2010  5:22AM | System | Time is not 240 h (+-30 min) from Start time of infusion | Site from System | Jul 20 2010  5:22AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  5:10AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  5:10AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  2:19AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  2:20AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  1:59AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  1:59AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0022 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010 12:16AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010 12:16AM | no window in protocol | S.Wittmann | 2020-07-27 00:00:00 | NK | Resolved
0001 0019 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  4:07AM | System | Time is not 48 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  4:08AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  4:13AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  4:13AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010 12:21AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010 12:22AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  2:10AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  2:10AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0023 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  2:59AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  2:59AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  5:13AM | System | Time is not 72 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  5:13AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  5:16AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  5:16AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  3:03AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  3:03AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010 12:26AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010 12:26AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  4:17AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  4:17AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  2:26AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  2:26AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0035 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  2:14AM | System | Time is not 120 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  2:14AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0023 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  3:08AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  3:08AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0028 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  5:39AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  5:40AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  5:20AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  5:22AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  6:13AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  6:13AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  6:57AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  6:57AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Queried
0001 0017 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 15 2010  7:18AM | System | Time is not 168 h (+-30 min) from Start time of infusion | Site from System | Jul 15 2010  7:19AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  4:46AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  4:47AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  2:01AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  2:01AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:45AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:46AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  5:17AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  5:17AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:03AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:04AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | 12h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  1:40AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  1:40AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0002 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 29 2010  6:44AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jul 16 2010 12:44AM | no window in protocol | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0019 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:24AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:24AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  4:57AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  4:57AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  1:27AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  1:27AM | no window in protocol | S.Wittmann | 2020-07-27 00:00:00 | NK | Resolved
0001 0023 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  2:08AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  2:08AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0029 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  5:05AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  5:06AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:51AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:51AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:07AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:07AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  2:00AM | System | Time is not 24 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  2:01AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0035 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  1:13AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  1:13AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:28AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:28AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  5:00AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  5:00AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  1:30AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  1:30AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  2:11AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  2:14AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  5:05AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  5:06AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0019 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:56AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:56AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:11AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:11AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  2:05AM | System | Time is not 36 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  2:05AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0035 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  1:16AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  1:16AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:32AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:32AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  5:03AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  5:03AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  1:35AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  1:37AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  1:42AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  1:42AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  5:08AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  5:08AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:37AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:37AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  1:22AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  1:23AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  1:24AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  1:24AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0019 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:38AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:39AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  5:09AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  5:10AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  1:44AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  1:44AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  1:56AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  1:57AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0029 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  5:18AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  5:18AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  4:59AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  4:59AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  4:30AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  4:31AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  4:10AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  4:10AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  3:44AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  3:44AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0017 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 20 2010  2:44AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 20 2010  2:44AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0013 | Day 11 (240h) | Vital Signs | VSTM | 0 | Answered | Jul 16 2010  3:25AM | System | Time is not 240 h (+-5 min) from Start time of infusion | Site from System | Jul 16 2010  3:25AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  [NAME] | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  5:03AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  2:17AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  2:17AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0019 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  3:59AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  3:59AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:14AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:15AM | no window in protocol | S.Wittmann | 2020-07-27 00:00:00 | NK | Resolved
0001 0035 | Day 3 (48h) | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  1:56AM | System | Time is not 48 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  1:57AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0035 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  2:07AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  2:08AM | no window in protocol | S.Wittmann | 2020-07-28 00:00:00 | NK | Queried
0001 0022 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:19AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:19AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  4:09AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  4:09AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0023 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  2:57AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  2:57AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  5:11AM | System | Time is not 72 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  5:11AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  5:14AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  5:14AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0023 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  3:00AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  3:01AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010 12:23AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010 12:23AM | no window in protocol | S.Wittmann | 2020-07-27 00:00:00 | NK | Resolved
0001 0019 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  4:14AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  4:14AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0028 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  2:22AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  2:23AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  2:11AM | System | Time is not 120 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  2:12AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0023 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  3:05AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  3:06AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  5:17AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  5:17AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0017 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  7:15AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  7:15AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0035 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  6:54AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  6:55AM | no window in protocol | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0028 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  5:35AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  5:35AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0022 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 15 2010  6:09AM | System | Time is not 168 h (+-5 min) from Start time of infusion | Site from System | Jul 15 2010  6:09AM | no window in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0041 | Study Completion and Withdrawal | Study Completion And Withdrawal | DSDECOD | 0 | Answered | Jul 16 2010  3:04AM | System | An Exclusion Criteria has been marked Yes, however, the reason for withdrawal is not Screening Failure. Please correct or clarify. | Site from System | Jul 16 2010  3:21AM | one coffee was consumed 48 hours prior to check in, medical officer reviewed = eligible | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0042 | Study Completion and Withdrawal | Study Completion And Withdrawal | DSDECOD | 0 | Answered | Jul 12 2010  5:04AM | System | An Exclusion Criteria has been marked Yes, however, the reason for withdrawal is not Screening Failure. Please correct or clarify. | Site from System | Jul 12 2010  5:05AM | PARTICIPANT HAD OUT OF RANGE CLINICAL LABORATORY RESULTS AT SCREENING. wHEN INFORMED THAT A2 WAS FULL, HE REFUSED TO ATTEND FOR REPEAT BLOODS | K.Beard | 2010-07-26 00:00:00 | NK | Resolved
0001 0041 | Visit Date and Cohort Selection | Cohort Selection | RAYN | 0 | Answered | Jul  6 2010  [NAME] | N.Kumari | one or more Exclusion Criteria have been answered Yes, however, the participant has been randomised. Please correct or clarify. | Site from DM | Jul  8 2010  6:25AM | participant was randomised to cohort 1A | S.Wittmann |  |  | Get clarified from Deepa
0001 0017 | 5h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 12 2010  6:30AM | System | Time is not 5 h (+-2 min) from Start time of infusion | Site from System | Jul 12 2010  6:31AM | PK sample was taken late in staff error | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0002 | Admission (Day -1) | Physical Examination | PEBS | 11 | Answered | Jul  7 2010  2:36AM | N.Kumari | An abnormal finding (SEE AE #01 CHEST CLEAR R=L. NO COUGH. NO LYMPHADENOPATHY, THROAT NORMAL - NCS) has been recorded for Body System  Other findings, however, it has not been recorded on the AE form. Please provide. | Site from DM | Jul  8 2010  5:17AM | see AE #01 | S.Wittmann |  |  | Referred to CRA for action
0001 0013 | 30h | Blood Sample Collection | BDTTM | 0 | Answered | Jun 29 2010  1:58AM | System | Time is not 30 h (+-2 min) from Start time of infusion | Site from System | Jul  1 2010  2:42AM | slow cannula | S.Wittmann | 2010-07-28 00:00:00 | NK | Resolved
0001 0026 | 4h | PK [NAME] | PUSTM | 0 | Answered | Jun 28 2010  1:16AM | System | Start time is not within one minute from Start time of infusion. Please correct or clarify. | Site from System | Jun 28 2010  1:17AM | start time is time of pre-dose sample ie time bladder emptied | E.King |  |  | Get clarified from Deepa start time for both 07:55
0001 0013 | Local Tolerability Assessment | Swelling | LTSPTM | 0 | Answered | Jun 29 2010  2:01PM | D.Raghavendra | Stop Time is not in line with the timepoint of last 'Yes' recorded. Please correct or clarify. | Site from DM | Jul  6 2010 10:56AM | stop time is correct on 25Jun10, which was Day 2 of the study. Yes recorded at 24hr as this is when the swelling was identified. | K.Beard | 2010-07-28 00:00:00 | NK | Queried
0001 0033 | Local Tolerability Assessment | Redness | LTSPTM | 0 | Answered | Jul  7 2010  2:26AM | N.Kumari | Stop Time is not in line with the timepoint of last 'Yes' recorded. Please correct or clarify. | Site from DM | Jul  9 2010  1:26AM | this is correct | S.Wittmann |  |  | Updated in ADL
0001 0028 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010  7:53AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010  7:54AM | TIME ENTERED IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 15 2010 12:15AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 15 2010 12:15AM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010 11:47PM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010 11:47PM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0017 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010  8:04AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010  8:04AM | TIME ENTERED IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010 11:38PM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010 11:38PM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 15 2010 12:31AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 15 2010 12:31AM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0022 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 15 2010 12:32AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 15 2010 12:32AM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0035 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010 11:40PM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010 11:40PM | time entered is correct | K.Beard | 2010-07-28 00:00:00 | NK | Queried
0001 0017 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010 11:30PM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010 11:30PM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0019 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010 11:49PM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010 11:49PM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 15 2010 12:17AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 15 2010 12:17AM | time entered is correct | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0028 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010  7:55AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010  7:55AM | TIME ENTERED IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0014 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010  7:47AM | System | Time is not 8 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010  7:48AM | TIME ENTERED IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 14 2010  8:34AM | System | Time is not 4 h (+-30 min) from Start time of infusion | Site from System | Jul 14 2010  8:34AM | TIME IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  [NAME] | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  [NAME] | TIME IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  8:31AM | System | Time is not 2 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  8:31AM | TIME IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0029 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  8:34AM | System | Time is not 4 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  8:34AM | TIME IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  8:36AM | System | Time is not 6 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  8:36AM | TIME IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Resolved
0001 0029 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 14 2010  8:36AM | System | Time is not 8 h (+-5 min) from Start time of infusion | Site from System | Jul 14 2010  8:36AM | TIME IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Resolved
0001 0014 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 12 2010 12:31AM | System | Time is not 1 h (+-5 min) from Start time of infusion | Site from System | Jul 12 2010 12:32AM | time is correct, 2 minute window not in protocol | S.Wittmann | 2010-07-27 00:00:00 | NK | Resolved
0001 0026 | 4h | PK [NAME] | PUETM | 0 | Answered | Jun 28 2010  1:16AM | System | End time is not 4 hours from Start time of infusion. Please correct or clarify. | Site from System | Jun 28 2010  1:17AM | time is time of last void in 4 hour period | E.King |  |  | Updated in ADL
0001 0026 | 8h | PK [NAME] | PUETM | 0 | Answered | Jun 28 2010  1:27AM | System | End time is not 8 hours from Start time of infusion. Please correct or clarify. | Site from System | Jun 28 2010  1:28AM | time is time of last void within time period | E.King |  |  | Updated in ADL
0001 0026 | Local Tolerability Assessment | Redness | LTSTTM | 0 | Answered | Jun 28 2010  1:23PM | D.Raghavendra | Start Time is not in line with timepoint of first 'Yes' recorded. Please correct or clarify. | Site from DM | Jul  7 2010  5:11AM | time of dose was 07:55 AE check performed at 08:57 therefore 1 hour after dosing | S.Wittmann | 2010-07-26 00:00:00 | NK | Resolved
0001 0014 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 14 2010  7:46AM | System | Time is not 2 h (+-20 min) from Start time of infusion | Site from System | Jul 14 2010  7:46AM | TIME STATED IS CORRECT | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jun 28 2010  9:16AM | System | Time is not 12 h (+-2 min) from Start time of infusion | Site from System | Jun 28 2010  9:17AM | time window not specified in protocol.  time entered is confirmed correct | K.Beard | 2010-07-28 00:00:00 | NK | Queried
0001 0026 | 12h | [NAME] | UDSTM | 0 | Answered | Jun 28 2010  9:18AM | System | Time is not 12 h (+-30 min) from Start time of infusion | Site from System | Jun 28 2010  9:18AM | time window not specified in protocol. Time entered is correct. | K.Beard | 2010-07-27 00:00:00 | NK | Queried
0001 0026 | 12h | Vital Signs | VSTM | 0 | Answered | Jun 28 2010  9:15AM | System | Time is not 12 h (+-5 min) from Start time of infusion | Site from System | Jun 28 2010  9:16AM | window not specified in protocol. time entered correct | K.Beard | 2010-07-27 00:00:00 | NK | Resolved