Spreadsheet: 81820d1281976775-macro-to-compare-entire-row-in-new_sheet-xls-new_sheet
Sheet: new sheet

2010-07-30 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 0022 | Day 8 (168h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 28 2010  5:10AM | N.Kumari | Thanks for the response.Per response 9 mins outside +- 2min sampling window difficult blood draw Protocol Deviation Codes: Deviation Protocol Deviation Class: Study Assessment(s) Not as per Protocol, however the reponse provided is 12 mins outside +-2 mins window.Please correct or clarify. | Site from DM | Jul 29 2010  1:42AM | 12 minutes outside window is correct | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 28 2010  5:30AM | N.Kumari | Thanks for the response.Per response,Sample required to be taken within +-2mins this is 13 minutes outside the window Protocol Deviation Codes: Deviation Protocol Deviation Class: Study Assessment(s) Not as per Protocol, however the response provided is 14 minutes outside the window protocol.Please correct or clarify. | Site from DM | Jul 29 2010  5:26AM | 14 minutes outside window confirmed | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0013 | Local Tolerability Assessment | Redness | LTSTTM | 0 | Answered | Jul 28 2010  8:07AM | N.Kumari | Thanks for the response.Start Time is not in line with timepoint of first 'Yes' recorded. Please correct or clarify | Site from DM | Jul 29 2010  5:35AM | 16:14 is timepoint when AE check was performed | S.Wittmann
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
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
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
0001 0013 | Local Tolerability Assessment | Swelling | LTSPTM | 0 | Answered | Jul 28 2010  8:02AM | N.Kumari | Thanks for the response.Per response,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, Day 2 date recorded as 24 Jun 2010.Please clarify. | Site from DM | Jul 29 2010  5:56AM | AE started on Day 2 24 Jun 10 and AE resolved on Day 3 25 Jun 10 | S.Wittmann
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
0001 0006 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 26 2010  6:58AM | N.Kumari | Thanks for the response.Time is not 12 h (+-2 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:52AM | blood collected taken outside the window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0041 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 28 2010  3:53AM | N.Kumari | Thanks for the response.Time is not 36 h (+-2 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:42AM | blood collection taken outside window | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0019 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 27 2010  4:01AM | N.Kumari | Thanks for the response.Time is not 12 h (+-2 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  4:09AM | blood sample taken outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0003 | 8h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 26 2010  4:08AM | N.Kumari | Thanks for the response. However,Time is not 8 h (+-2 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  2:10AM | bloods collected outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | Day 11 (240h) | Blood Sample Collection | BDTTM | 0 | Answered | Jul 27 2010  3:33AM | N.Kumari | Thanks for the response.Time is not 240 h (+-2 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:55AM | bloods taken outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
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
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
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
0001 0003 | Day 3 (48h) | Blood Sample Collection | BDYN1 | 3 | Answered | Jul 21 2010  2:12AM | N.Kumari | Thanks for the response.Nois selected for collected?, but a response is provided at 'Is the date and time of sample collection the same as the date recorded above?'as Yes. Please correct or clarify. | Site from DM | Jul 28 2010  2:28AM | data corrected | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | Day 4 (72h) | Blood Sample Collection | BDYN1 | 1 | Answered | Jul 29 2010 12:23AM | System | Yes is selected, but a date and/or time is provided. Please correct. | Site from System | Jul 29 2010 12:26AM | data corrected | S.Wittmann
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
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
0001 0014 | Day 4 (72h) | Blood Sample Collection | BDYN1 | 8 | Answered | Jul 29 2010 12:23AM | System | No is selected, however, a date and/or time is not provided | Site from System | Jul 29 2010 12:26AM | data cprrected | S.Wittmann | 2010-08-02 00:00:00 | NK
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
0001 0028 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 28 2010  5:44AM | N.Kumari | Thanks for the response.Per response, mins outside +-2min sampling time  Protocol Deviation Codes: Violation Protocol Deviation Class: Study Assessment(s) Not as per Protocol, the response provided is  minutes outside the window protocol.Please correct or clarify. | Site from DM | Jul 29 2010 12:41AM | data is 5 minutes outside window | S.Wittmann
0001 0005 | 18h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 26 2010  6:15AM | N.Kumari | Thanks for the response.  Time is not 18 h (+-2 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  3:59AM | data is correct | S.Wittmann
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
0001 0028 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 28 2010  6:20AM | N.Kumari | Thanks for the response.Per response,13mins outside the +-2min sampling window Protocol Deviation Codes: Deviation Protocol Deviation Class: Study Assessment(s) Not as per Protocol, the response provided is 12 mins outside the protocol window.Please correct or clarify. | Site from DM | Jul 29 2010 12:42AM | data is correct | S.Wittmann
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
0001 0003 | 8h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  5:25AM | N.Kumari | Thanks for the repsonse. Time is not 8 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:10AM | data is correct | S.Wittmann
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
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
0001 0003 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  5:26AM | N.Kumari | Thanks for the repsonse. Time is not 12 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:17AM | data is correct | S.Wittmann
0001 0011 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:41AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:32AM | data is correct | S.Wittmann
0001 0006 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:04AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion. Please correct ot clarify. | Site from DM | Jul 28 2010  4:57AM | data is correct | S.Wittmann
0001 0006 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:06AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion . Please correct or clarify. | Site from DM | Jul 28 2010  4:45AM | data is correct | S.Wittmann
0001 0003 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  5:28AM | N.Kumari | Thanks for the response. Time is not 4 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:07AM | data is correct | S.Wittmann
0001 0003 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  5:31AM | N.Kumari | Thanks for the response. Time is not 8 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:11AM | data is correct | S.Wittmann
0001 0005 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  6:30AM | N.Kumari | Thanks for the response. Time is not 8 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  3:51AM | data is correct | S.Wittmann
0001 0006 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:07AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:48AM | data is correct | S.Wittmann
0001 0006 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:09AM | N.Kumari | Thanks for the response.Time is not 48 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:00AM | data is correct | S.Wittmann
0001 0005 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  6:32AM | N.Kumari | Thanks for the response.Time is not 48 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:05AM | data is correct | S.Wittmann
0001 0006 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:12AM | N.Kumari | Thanks for the response.Time is not 72 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  [NAME] | data is correct | S.Wittmann
0001 0006 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:13AM | N.Kumari | Thanks for the repsonse.Time is not 120 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:03AM | data is correct | S.Wittmann
0001 0005 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  6:11AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:11AM | data is correct | S.Wittmann
0001 0002 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  4:57AM | N.Kumari | Thanks for the response.ime is not 120 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  1:45AM | data is correct | S.Wittmann
0001 0003 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  5:39AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:38AM | data is correct | S.Wittmann
0001 0011 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:46AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:39AM | data is correct | S.Wittmann
0001 0003 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  5:40AM | N.Kumari | Thanks for the response. Time is not 168 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:42AM | data is correct | S.Wittmann
0001 0005 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  6:40AM | N.Kumari | Thanks for the response. Time is not 168 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:14AM | data is correct | S.Wittmann
0001 0006 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:14AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:07AM | data is correct | S.Wittmann
0001 0003 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  5:52AM | N.Kumari | Thanks for the response.Time is not 36 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:24AM | data is correct | S.Wittmann
0001 0002 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  5:13AM | N.Kumari | Thanks for the response. Time is not 120 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  1:45AM | data is correct | S.Wittmann
0001 0005 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  6:50AM | N.Kumari | Thanks for the response. Time is not 168 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  4:14AM | data is correct | S.Wittmann
0001 0002 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  5:15AM | N.Kumari | Thanks for the response. Time is not 168 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  1:47AM | data is correct | S.Wittmann
0001 0011 | 0.5h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  7:55AM | N.Kumari | Thanks for the response.Time is not 0.5 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:22AM | data is correct in the window | S.Wittmann
0001 0006 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:02AM | N.Kumari | Thanks for the response. Time is not 12 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:53AM | data is correct inside window | S.Wittmann
0001 0011 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:42AM | N.Kumari | Thanks for the response.Time is not 48 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:33AM | data is correct inside window | S.Wittmann
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
0001 0006 | 8h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  7:00AM | N.Kumari | Thanks for the response. Time is not 8 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:49AM | data is correct within the window | S.Wittmann
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
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
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
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
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
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
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
0001 0023 | 4h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 27 2010  4:51AM | N.Kumari | Thanks for the response.Time is not 4 h (+-2 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:47AM | data is outside of window in error | S.Wittmann
0001 0011 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  7:24AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:23AM | data is within the window | S.Wittmann
0001 0041 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  3:55AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:42AM | data is within the window | S.Wittmann
0001 0023 | 36h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 28 2010  5:22AM | N.Kumari | Thanks for the response.Time is not 36 h (+-2 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:50AM | data is within window | S.Wittmann
0001 0023 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  4:50AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:46AM | data is within window | S.Wittmann
0001 0028 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  5:41AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:37AM | data is within window | S.Wittmann
0001 0041 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 28 2010  2:47AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:31AM | data is within window | S.Wittmann
0001 0035 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  8:12AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:03AM | data is within window | S.Wittmann
0001 0035 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 28 2010  1:35AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:06AM | data is within window | S.Wittmann
0001 0028 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  5:45AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:39AM | data is within window | S.Wittmann
0001 0023 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  4:54AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:48AM | data is within window | S.Wittmann
0001 0022 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  4:30AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:36AM | data is within window | S.Wittmann
0001 0041 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 28 2010  3:42AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:36AM | data is within window | S.Wittmann
0001 0033 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 27 2010  6:41AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  5:59AM | data is within window | S.Wittmann
0001 0017 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 27 2010  3:53AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:48AM | data is within window | S.Wittmann
0001 0017 | 8h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 27 2010  3:55AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:49AM | data is within window | S.Wittmann
0001 0033 | 8h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 27 2010  6:49AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:02AM | data is within window | S.Wittmann
0001 0011 | 8h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  7:39AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:26AM | data is within window | S.Wittmann
0001 0011 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:52AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:27AM | data is within window | S.Wittmann
0001 0017 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  3:39AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:50AM | data is within window | S.Wittmann
0001 0033 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:39AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:04AM | data is within window | S.Wittmann
0001 0028 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:38AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:39AM | data is within window | S.Wittmann
0001 0041 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  2:43AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:39AM | data is within window | S.Wittmann
0001 0035 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  7:52AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:09AM | data is within window | S.Wittmann
0001 0023 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:47AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:49AM | data is within window | S.Wittmann
0001 0023 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:58AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:50AM | data is within window | S.Wittmann
0001 0022 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:36AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:38AM | data is within window | S.Wittmann
0001 0029 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:29AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:13AM | data is within window | S.Wittmann
0001 0035 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  1:47AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:16AM | data is within window | S.Wittmann
0001 0033 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  7:02AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:08AM | data is within window | S.Wittmann
0001 0017 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  3:45AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:52AM | data is within window | S.Wittmann
0001 0019 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:13AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:28AM | data is within window | S.Wittmann
0001 0033 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:43AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:00AM | data is within window | S.Wittmann
0001 0017 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  3:47AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:48AM | data is within window | S.Wittmann
0001 0028 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:43AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:38AM | data is within window | S.Wittmann
0001 0035 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  8:30AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:05AM | data is within window | S.Wittmann
0001 0022 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:27AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:36AM | data is within window | S.Wittmann
0001 0029 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:21AM | N.Kumari | Thanks for your response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:11AM | data is within window | S.Wittmann
0001 0023 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:52AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:48AM | data is within window | S.Wittmann
0001 0011 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:51AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:24AM | data is within window | S.Wittmann
0001 0041 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  2:51AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:32AM | data is within window | S.Wittmann
0001 0041 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  3:44AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:35AM | data is within window | S.Wittmann
0001 0011 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  7:53AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  5:26AM | data is within window | S.Wittmann
0001 0023 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:54AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:49AM | data is within window | S.Wittmann
0001 0029 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:24AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:12AM | data is within window | S.Wittmann
0001 0022 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:30AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:37AM | data is within window | S.Wittmann
0001 0035 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  1:42AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:05AM | data is within window | S.Wittmann
0001 0017 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  3:48AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:48AM | data is within window | S.Wittmann
0001 0033 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:50AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:02AM | data is within window | S.Wittmann
0001 0035 | Day 11 (240h) | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  1:50AM | N.Kumari | Thanks for the response.Time is not 240 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:19AM | data is within window | S.Wittmann
0001 0033 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  7:15AM | N.Kumari | Thanks for the response.Time is not 48 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:10AM | data is within window | S.Wittmann
0001 0033 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  7:19AM | N.Kumari | Thanks for the response.Time is not 72 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:11AM | data is within window | S.Wittmann
0001 0041 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  4:33AM | N.Kumari | Thanks for the response. Time is not 120 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  6:48AM | data is within window | S.Wittmann
0001 0035 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  2:01AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:18AM | data is within window | S.Wittmann
0001 0029 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:33AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:14AM | data is within window | S.Wittmann
0001 0022 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:42AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:39AM | data is within window | S.Wittmann
0001 0017 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  3:38AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:53AM | data is within window | S.Wittmann
0001 0019 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:18AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:29AM | data is within window | S.Wittmann
0001 0023 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:03AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:51AM | data is within window | S.Wittmann
0001 0029 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  6:35AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:15AM | data is within window | S.Wittmann
0001 0022 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:44AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:40AM | data is within window | S.Wittmann
0001 0035 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  2:04AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:19AM | data is within window | S.Wittmann
0001 0017 | 0.5h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:41AM | N.Kumari | Thanks for the response.Time is not 0.5 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:46AM | data is within window | S.Wittmann
0001 0026 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 28 2010  5:38AM | N.Kumari | Thnaks for the response.Per response,vitals are inside window.Time is not 36 h (+-5 min) from Start time of infusion.Please correct or clarify | Site from DM | Jul 29 2010  5:27AM | data is within window | S.Wittmann
0001 0011 | Day 8 (168h) | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  7:49AM | N.Kumari | Thanks for the response.Time is not 168 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:41AM | data is within window | S.Wittmann
0001 0023 | 12h | Blood Sample Collection | BDTTM | 0 | Answered | Jul 27 2010  4:47AM | N.Kumari | Thanks for the response.Time is not 12 h (+-2 min) from Start time of infusion.Please correct or clarify | Site from DM | Jul 29 2010  1:50AM | data is within window, dose was at 12:00 | S.Wittmann
0001 0022 | Adverse Events | Adverse Events/SAEs | AETERM | 2 | Answered | Jul 20 2010 11:06AM | M.Shanmugasundaram | CODING QUERY: For the AE Term "RAISED BUMPS ON LEFT FOREARM RED AND ITCHY" please specify a single diagnosis if known, else please split and report the terms on individual lines for coding to occur. | Site from DM | Jul 26 2010  5:12AM | data updated | S.Wittmann
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
0001 0026 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:33AM | N.Kumari | Thanks for the resposne.Time is not 168 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:52AM | dose was at 0755, still with in window | S.Wittmann
0001 0026 | 1h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:09AM | N.Kumari | Thanks for the response.Time is not 1 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:21AM | dose was at 0755, therefore within the window | S.Wittmann
0001 0014 | 8h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 27 2010  3:34AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:42AM | dose was at 0800 therefore inside the window | S.Wittmann
0001 0014 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  2:42AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:43AM | dose was at 0800 therefore inside the window | S.Wittmann
0001 0014 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 27 2010  3:29AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:36AM | dose was at 0800, ecg taken within the +-20 minutes | S.Wittmann
0001 0002 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  4:43AM | N.Kumari | Thanks for the response. Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  6:21AM | dose was at 0800, therefore ecg is within the window | S.Wittmann
0001 0002 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  4:55AM | N.Kumari | Thanks for the response. Time is not 48 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  1:41AM | dose was at 0800, therefore inside the window | S.Wittmann
0001 0002 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  5:17AM | N.Kumari | Thanks for the response. Time is not 12 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  1:25AM | dose was at 0800, therefore inside window | S.Wittmann
0001 0014 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  2:45AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  3:41AM | dose was at 0800. therefore inside window | S.Wittmann
0001 0003 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  5:23AM | N.Kumari | Thanks for the response. Time is not 2 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:06AM | dose was at 0900, therefore inside the window | S.Wittmann
0001 0005 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  6:17AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  3:48AM | dose was at 1000, therefore inside the window | S.Wittmann
0001 0019 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  4:05AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:07AM | dose was at 1100 ecg performed within window | S.Wittmann
0001 0022 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:22AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:25AM | dose was at 1130, therefore inside the window | S.Wittmann
0001 0013 | 8h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 26 2010  4:16AM | N.Kumari | Thanks for the repsonse.Time is not 8 h (+-20 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010 12:33AM | dosing was 0820, ecg performed within 20 minutes window | S.Wittmann
0001 0013 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  1:15AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:35AM | dosing was at 0820, therefore inside the window | S.Wittmann
0001 0013 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  8:19AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010 12:54AM | dosing was at 0820, urine performed within 30 minute window | S.Wittmann
0001 0013 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  4:37AM | N.Kumari | Thanks for the response.Time is not 6 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010 12:30AM | dosing was at 0820,vitals performed within the 5 minute window | S.Wittmann
0001 0026 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  5:16AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:31AM | ecg is within window | S.Wittmann
0001 0019 | 8h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  4:09AM | N.Kumari | Thanks for the response.Time is not 8 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:11AM | ecg performed outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | 2h | 12-Lead ECG | EGTMPT | 1 | Answered | Jul 27 2010  5:11AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:24AM | ecg performed within the window as dose was at 0755 | S.Wittmann
0001 0022 | 2h | 12-Lead ECG | EGTM1 | 1 | Answered | Jul 27 2010  4:26AM | N.Kumari | Thanks for the response.Time is not 2 h (+-20 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:26AM | ecg was taken inside the window | S.Wittmann
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
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
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
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
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
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
0001 0033 | 0h | Study Product Administration | SPIENTM | 5 | Answered | Jul 29 2010  6:23AM | System | Yes is selected, however, [NAME] time of infusion is missing. Please provide. | Site from System | Jul 29 2010  6:29AM | infusion did not restart after 14:51 interruption | S.Wittmann
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
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
0001 0013 | Day 15 (Follow-up) | Meals (In Study Unit) | MEALYN | 0 | Answered | Jul 27 2010 12:59AM | System | No is selected, however, a reason is not provided. Please correct. | Site from System | Jul 27 2010  1:00AM | reason entered above | S.Wittmann
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 | 2010-08-02 00:00:00 | NK
0001 0002 | Admission (Day -1) | Physical Examination | PERSLT | 11 | Answered | Jul 27 2010  6:15AM | System | Normal or Not Done is selected, however, Description of abnormal or significant findings is provided. Please correct. | Site from System | Jul 27 2010  6:16AM | see AE#01 | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0006 | Admission (Day -1) | Visit Date | VISDT | 0 | Answered | Jul 21 2010  1:17AM | N.Kumari | Thanks for the response, however [NAME] of visit is not one day before the date of infusion.Please clarify. | Site from DM | Jul 28 2010  4:38AM | some day -1 procedures actually were done on day -2 due to delay to intended dosing date. discussed with sponsor | S.Wittmann | 2010-08-02 00:00:00 | NK
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
0001 0033 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  6:47AM | N.Kumari | Thanks for the response.Per response,This sample has been taken 31 mins outside the assessment window Protocol Deviation Codes: Deviation Protocol Deviation Class: Study Assessment(s) Not as per Protocol. The response provided is 46 minutes outside the assessment window protocol deviation.Please correct or clarify. | Site from DM | Jul 29 2010  6:41AM | time is correct as per source book | S.Wittmann
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
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
0001 0033 | 0h | Study Product Administration | SPMIU1 | 5 | Answered | Jul 29 2010  6:23AM | System | Yes is selected, however, Volume administered is missing. Please provide. | Site from System | Jul 29 2010  6:29AM | unknown volume in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0033 | 0h | Study Product Administration | SPMIU1 | 3 | Answered | Jul 29 2010  6:21AM | System | Yes is selected, however, Volume administered is missing. Please provide. | Site from System | Jul 29 2010  6:27AM | unknown volume in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0033 | 0h | Study Product Administration | SPMIU1 | 4 | Answered | Jul 29 2010  6:22AM | System | Yes is selected, however, Volume administered is missing. Please provide. | Site from System | Jul 29 2010  6:27AM | unknown volume in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0041 | Day 3 (48h) | [NAME] | UDSTM | 0 | Answered | Jul 28 2010  4:01AM | N.Kumari | Thanks for the response.Time is not 48 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:45AM | urine collection outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0002 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  4:50AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  6:21AM | urine is within the window | S.Wittmann
0001 0026 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:17AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:30AM | urine is within time window | S.Wittmann
0001 0013 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  1:10AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  4:50AM | urine not taken within window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | Day 8 (168h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  2:50AM | N.Kumari | Thanks for the response.Time is not 168 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:53AM | [NAME] window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  2:44AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:46AM | urine performed within the window | S.Wittmann
0001 0019 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:07AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:08AM | [NAME] 15 minutes outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0019 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:09AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:11AM | [NAME] 5 minutes outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0013 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  1:06AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  4:38AM | [NAME] of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0002 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  4:49AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion .Please correct or clarify. | Site from DM | Jul 28 2010  1:38AM | [NAME] of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0003 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  4:25AM | N.Kumari | Thanks for your response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  2:26AM | [NAME] of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0013 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  1:12AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion. Please correct ot clarify. | Site from DM | Jul 27 2010  4:37AM | [NAME] of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0028 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:46AM | N.Kumari | Thanks for the response. Time is not 8 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:38AM | [NAME] of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | Day 6 (120h) | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:31AM | N.Kumari | Thanks for the response.Time is not 120 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:45AM | [NAME] of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0003 | Day 4 (72h) | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  5:38AM | N.Kumari | Thanks for the response. Time is not 72 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:30AM | [NAME] of window in errro | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:08AM | N.Kumari | Thanks for the response.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:32AM | [NAME] of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0019 | 12h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  4:01AM | N.Kumari | Thanks for the repsonse.Time is not 12 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:10AM | [NAME] of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0002 | 8h | [NAME] | UDSTM | 0 | Answered | Jul 26 2010  4:52AM | N.Kumari | Thanks for the response.Time is not 8 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  1:20AM | [NAME] of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | 36h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:23AM | N.Kumari | Thanks for the response.Time is not 36 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:38AM | urine taken within the window | S.Wittmann
0001 0014 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  3:31AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:37AM | urine was taken early due to staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0013 | 24h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  1:09AM | N.Kumari | Thanks for the response.Time is not 24 h (+-30 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  4:48AM | urine was taken outside of the window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | 4h | [NAME] | UDSTM | 0 | Answered | Jul 27 2010  5:13AM | N.Kumari | Thanks for the response.Time is not 4 h (+-30 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:25AM | urnine taken early, outside of window due to staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0033 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  6:46AM | N.Kumari | Thanks for the response.Time is not 8 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:02AM | vital performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0002 | 36h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  5:06AM | N.Kumari | Thanks for the response.Time is not 36 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  1:37AM | vitals outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:27AM | N.Kumari | Thanks for the response.Time is not 120 h (+-5 min) from Start time of infusion. Please correct ot clarify. | Site from DM | Jul 27 2010  3:53AM | vitals performed 5 minutes early in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:30AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:45AM | vitals performed outside of window due to staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0003 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  5:43AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:22AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0003 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  5:50AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  2:06AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0005 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  6:45AM | N.Kumari | Thanks for the response. Time is not 2 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  3:47AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0017 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:52AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:47AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0017 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:50AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:53AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:26AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:47AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0028 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:51AM | N.Kumari | Thanks for the response. Time is not 72 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:43AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0017 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:37AM | N.Kumari | Thanks for the response.Time is not 120 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:53AM | vitals performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0019 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  4:04AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:06AM | vitals performed outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:15AM | N.Kumari | Thanks for the response.Time is not 8 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:28AM | vitals performed outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0005 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  6:26AM | N.Kumari | Thanks for the response. Time is not 24 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  3:59AM | vitals performed outside the window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0006 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  7:20AM | N.Kumari | Thanks for the response. Time is not 24 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:55AM | vitals performed outside the window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0006 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  6:54AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:44AM | vitals performed outside the window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0011 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  7:34AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:22AM | vitals performed outside the window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0006 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  7:18AM | N.Kumari | Thanks for the response.Time is not 8 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  4:48AM | vitals performed outside the window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0041 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 28 2010  3:46AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:41AM | vitals performed outside window | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0011 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  7:40AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:29AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0017 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:43AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 29 2010 12:50AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0022 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  4:32AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:38AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0028 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:48AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:42AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0033 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  6:57AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:06AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0029 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  6:26AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:12AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0023 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  4:49AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:46AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0028 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:40AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010 12:37AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0041 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 28 2010  2:46AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:30AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0029 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  6:15AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:09AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0035 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  8:11AM | N.Kumari | Thanks for the respponse.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:03AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0033 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  6:41AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  5:59AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0033 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  6:43AM | N.Kumari | Thanks for the response.Time is not 4 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:00AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0041 | 4h | Vital Signs | VSTM | 0 | Answered | Jul 28 2010  2:50AM | N.Kumari | Thanks for the response.Time is not 4 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:32AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0011 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  7:37AM | N.Kumari | Thanks for the response.Time is not 8 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 28 2010  5:25AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0041 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 28 2010  3:40AM | N.Kumari | Thanks for the response.Time is not 8 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:35AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0019 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  4:16AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:28AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0035 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 28 2010  1:57AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:18AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0022 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  4:41AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:39AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0023 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:01AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  1:51AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0029 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  6:32AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 29 2010  2:14AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0041 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 28 2010  4:08AM | N.Kumari | Thanks for the response.Time is not 120 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 28 2010  6:48AM | vitals performed outside window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:30AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:35AM | vitals performed outside window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0002 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  [NAME] | N.Kumari | Thanks for the response. Time is not 24 h (+-5 min) from Start time of infusion . Please correct or clarify. | Site from DM | Jul 28 2010  1:28AM | vitals taken 5 minutes outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  2:43AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:44AM | vitals were performed 5 minutes early due to staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0013 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  1:08AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  4:48AM | vitals were performed 5 minutes outside of window | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0019 | 24h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  4:11AM | N.Kumari | Thanks for the response.Time is not 24 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:12AM | vitals were performed 5 minutes outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0013 | Day 6 (120h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  1:22AM | N.Kumari | Thanks for the response.Time is not 120 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  4:36AM | vitals were performed 5 minutes outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | 8h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  3:24AM | N.Kumari | Thanks for the response.Time is not 8 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:40AM | vitals were performed early due to staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0002 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 26 2010  5:04AM | N.Kumari | Thanks for the response. Time is not 2 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  6:20AM | vitals were performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0013 | Day 4 (72h) | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  1:21AM | N.Kumari | Thanks for the response.Time is not 72 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  4:51AM | vitals were performed outside of window in error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0026 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  5:10AM | N.Kumari | Thanks for the response.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  5:23AM | vitals were performed outside of window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0022 | 2h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  4:25AM | N.Kumari | Thanks for the repsonse.Time is not 2 h (+-5 min) from Start time of infusion.Please correct or clarify. | Site from DM | Jul 27 2010  4:26AM | vitals were performed outside the window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK
0001 0014 | 6h | Vital Signs | VSTM | 0 | Answered | Jul 27 2010  2:41AM | N.Kumari | Thanks for the response.Time is not 6 h (+-5 min) from Start time of infusion. Please correct or clarify. | Site from DM | Jul 27 2010  3:38AM | vitals were performed outside window in staff error | S.Wittmann | 2010-08-02 00:00:00 | NK