Extraction schema:
{"type": "object", "properties": {"appendix_number": {"type": "string"}, "appendix_title": {"type": "string"}, "study_number": {"type": "string"}, "sponsor_protocol_number": {"type": "string"}, "application": {"type": "string"}, "application_version": {"type": "string"}, "printed_by": {"type": "string"}, "printed_at": {"type": "string"}, "report_title": {"type": "string"}, "category": {"type": "string"}, "deviation_entries": {"type": "array", "items": {"type": "object", "properties": {"tracking_id": {"type": "string"}, "creation_date": {"type": "string"}, "status": {"type": ["string", "null"]}, "subcategory": {"type": "string"}, "source_page": {"type": "integer"}}, "required": ["tracking_id", "creation_date", "status", "subcategory", "source_page"]}}, "communications": {"type": "array", "items": {"type": "object", "properties": {"entry_tracking_id": {"type": "string"}, "comment_index": {"type": "integer"}, "author": {"type": "string"}, "commented_at": {"type": "string"}, "text": {"type": "string"}, "source_page": {"type": "integer"}}, "required": ["entry_tracking_id", "comment_index", "author", "commented_at", "text", "source_page"]}}}, "required": ["appendix_number", "appendix_title", "category", "deviation_entries", "communications"]}

Expected output:
{"appendix_number": "16.2.2", "appendix_title": "Protocol Deviations", "study_number": "7694-105", "sponsor_protocol_number": "SM 08-01", "application": "eNotes", "application_version": "2.11.0", "printed_by": "Sheri Bernard", "printed_at": "18 Aug 2010, 07:48 PM (GMT -5)", "report_title": "Category Report", "category": "Protocol Deviation", "deviation_entries": [{"tracking_id": "536180", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Protocol Issued", "source_page": 2}, {"tracking_id": "465892", "creation_date": "01-Jul-2009", "status": "Approved", "subcategory": "Inclusion/Exclusion", "source_page": 3}, {"tracking_id": "582026", "creation_date": "03-Jun-2010", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 5}, {"tracking_id": "554466", "creation_date": "17-Mar-2010", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 5}, {"tracking_id": "541563", "creation_date": "11-Feb-2010", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 5}, {"tracking_id": "521002", "creation_date": "09-Dec-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 5}, {"tracking_id": "520679", "creation_date": "08-Dec-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 6}, {"tracking_id": "519003", "creation_date": "03-Dec-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 6}, {"tracking_id": "486528", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 7}, {"tracking_id": "486183", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 7}, {"tracking_id": "486182", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 7}, {"tracking_id": "486181", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 8}, {"tracking_id": "486180", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 8}, {"tracking_id": "486179", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 8}, {"tracking_id": "486178", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 8}, {"tracking_id": "486176", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 9}, {"tracking_id": "486174", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 9}, {"tracking_id": "486173", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 9}, {"tracking_id": "486170", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 9}, {"tracking_id": "486169", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 10}, {"tracking_id": "484319", "creation_date": "25-Aug-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 10}, {"tracking_id": "481013", "creation_date": "14-Aug-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 10}, {"tracking_id": "461545", "creation_date": "18-Jun-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 11}, {"tracking_id": "458680", "creation_date": "10-Jun-2009", "status": "Approved", "subcategory": "Other Study Restrictions/Requirements", "source_page": 11}, {"tracking_id": "567211", "creation_date": "21-Apr-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 12}, {"tracking_id": "567177", "creation_date": "21-Apr-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 12}, {"tracking_id": "560703", "creation_date": "05-Apr-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 14}, {"tracking_id": "551110", "creation_date": "09-Mar-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 14}, {"tracking_id": "548143", "creation_date": "01-Mar-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 15}, {"tracking_id": "542864", "creation_date": "15-Feb-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 15}, {"tracking_id": "539288", "creation_date": "04-Feb-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 15}, {"tracking_id": "536303", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 16}, {"tracking_id": "536300", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 16}, {"tracking_id": "536296", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 16}, {"tracking_id": "536284", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 17}, {"tracking_id": "536278", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 17}, {"tracking_id": "536272", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 17}, {"tracking_id": "536267", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 18}, {"tracking_id": "536261", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 18}, {"tracking_id": "536252", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 18}, {"tracking_id": "536246", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 18}, {"tracking_id": "536243", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 19}, {"tracking_id": "536237", "creation_date": "27-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 19}, {"tracking_id": "531726", "creation_date": "14-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 19}, {"tracking_id": "531331", "creation_date": "13-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 20}, {"tracking_id": "531309", "creation_date": "13-Jan-2010", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 20}, {"tracking_id": "527283", "creation_date": "30-Dec-2009", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 20}, {"tracking_id": "527280", "creation_date": "30-Dec-2009", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 20}, {"tracking_id": "510840", "creation_date": "10-Nov-2009", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 21}, {"tracking_id": "502029", "creation_date": "16-Oct-2009", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 21}, {"tracking_id": "480138", "creation_date": "12-Aug-2009", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 22}, {"tracking_id": "480126", "creation_date": "12-Aug-2009", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 22}, {"tracking_id": "431526", "creation_date": "20-Mar-2009", "status": "Approved", "subcategory": "Safety Evaluations (Study Events)", "source_page": 22}, {"tracking_id": "486172", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Data Management", "source_page": 24}, {"tracking_id": "486171", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Data Management", "source_page": 24}, {"tracking_id": "486168", "creation_date": "01-Sep-2009", "status": "Approved", "subcategory": "Data Management", "source_page": 24}, {"tracking_id": "481010", "creation_date": "14-Aug-2009", "status": "Approved", "subcategory": "Data Management", "source_page": 24}, {"tracking_id": "580475", "creation_date": "28-May-2010", "status": "Approved", "subcategory": "Sample Processing", "source_page": 25}, {"tracking_id": "501410", "creation_date": "15-Oct-2009", "status": "Pending Reply", "subcategory": "PharmacoDynamic", "source_page": 26}], "communications": [{"entry_tracking_id": "536180", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:14 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 2}, {"entry_tracking_id": "536180", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:14 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 2}, {"entry_tracking_id": "536180", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 10:29 AM (GMT -5)", "text": "Subject # 4093 was randomized 42 days outside of the window visit. A waiver was sent to Dr. Dixon for approval after the randomization occurred.", "source_page": 2}, {"entry_tracking_id": "465892", "comment_index": 1, "author": "David Carter", "commented_at": "01 Jul 2009, 02:32 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 3}, {"entry_tracking_id": "465892", "comment_index": 2, "author": "David Carter", "commented_at": "01 Jul 2009, 02:32 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 3}, {"entry_tracking_id": "465892", "comment_index": 3, "author": "David Carter", "commented_at": "01 Jul 2009, 02:32 PM (GMT -5)", "text": "Noted.", "source_page": 3}, {"entry_tracking_id": "465892", "comment_index": 4, "author": "David Stockert", "commented_at": "01 Jul 2009, 12:11 PM (GMT -5)", "text": "On 09 APR 2009, it was discovered that 11 study participants (001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011) had been consented with an outdated ICF (version “12/30/08”). The following ICF versions available are:\n\nVersion dated 11/18/08 – IRB approved 18 NOV 2008\nVersion dated 12/30/08 – IRB approved 30 DEC 2008\nVersion dated 1/20/09 – IRB approved 20 JAN 2009\nVersion dated 3/16/09 – IRB approved 16 MAR 2009\nVersion dated 3/16/09 (corrected document) – IRB approved 13 APR 2009\n\nAt the time of screening, which occurred between 05 MAR 2009 and 24 MAR 2009, 11 participants had consented to the study by signing an ICF version dated and approved on 30 DEC 2008. At the time of the screening visits, the 11 participants should have been consented with the available ICF version dated and approved on 20 JAN 2009.\n\nOf the 11 participants, 6 had enrolled into the study as allowed per protocol eligibly requirements. The baseline visits (test material dispensing visit) had occurred between the dates of 13 MAR 2009 and 26 MAR 2009. Three of the six enrolled subjects with screening numbers 001, 002, and 003 completed their baseline visit prior to 16 Mar 2009. These subjects were not re-consented with the available 20 JAN 2009 dated ICF upon their baseline visit. The remaining 3 enrolled subjects with screening numbers 005, 008, and 009 completed their baseline visits between the dates of 23 MAR 2009 and 26 Mar 2009. These subjects with screening numbers 005, 008, and 009 were not re-consented upon their baseline visits with the latest available ICF version dated and approved on 16 MAR 2009.\n\nThe ICF dated “1/20/09” differs from the ICF dated “12/30/08” in that additional wording was added to include a lab test (FSH) for women between the ages of 45 and 55 to confirm their post-menopausal status. The difference between the ICFs dated “1/20/09” and “3/16/09”, is additional added wording which clarifies \"Nicoderm\" and Nicorette\" as a \"Nicotine Replacement Therapy\". The “3/16/09” version of the ICF was re-approved by the IRB on 13 APR 2009 in regards to minor typographical errors.\n\nOf the 11 participants, subject with screening number 005 had the FSH test added to their lab panel as per a requirement of the protocol. For clarification, the FSH test was conducted without the subject's consent as only the ICF dated 12/30/08 was signed by the participant upon her screening visit.\n\nWith the exception of subject 001 who withdrew consent on 13 APR 2009, the following 5 enrolled subjects were re-consented with the latest (13 APR 2009) IRB approved version of the ICF at their week 6 in-clinic visit (baseline visit):\n002 29-Apr-2009\n003 28-Apr-2009\n005 04-May-2009\n008 05-May-2009\n009 07-May-2009\nAttached to this eNote is a copy of a submitted “Potential Unanticipated Problem or Serious or Continuing Non-Compliance” Investigational Review Board (IRB) form which was acknowledged by the IRB on 21 APR 2009.", "source_page": 3}, {"entry_tracking_id": "582026", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "03 Jun 2010, 01:53 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 5}, {"entry_tracking_id": "582026", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "03 Jun 2010, 01:53 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 5}, {"entry_tracking_id": "582026", "comment_index": 3, "author": "Faye Terry", "commented_at": "03 Jun 2010, 11:17 AM (GMT -5)", "text": "RE: Subject 4053\n\nThe above-referenced subject used Chantix and did not report this to the staff until the early termination visit. This is a protocol violation and there is no impact on the study.", "source_page": 5}, {"entry_tracking_id": "554466", "comment_index": 1, "author": "William Lewis", "commented_at": "17 Mar 2010, 03:27 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 5}, {"entry_tracking_id": "554466", "comment_index": 2, "author": "William Lewis", "commented_at": "17 Mar 2010, 03:27 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 5}, {"entry_tracking_id": "554466", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "17 Mar 2010, 12:40 PM (GMT -5)", "text": "Subject #5027 did not complete the Week 1 Phone call per protocol and there is no source documentation regarding attempts to reach them in error.", "source_page": 5}, {"entry_tracking_id": "541563", "comment_index": 1, "author": "David Carter", "commented_at": "11 Feb 2010, 02:05 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 5}, {"entry_tracking_id": "541563", "comment_index": 2, "author": "David Carter", "commented_at": "11 Feb 2010, 02:05 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 5}, {"entry_tracking_id": "541563", "comment_index": 3, "author": "David Carter", "commented_at": "11 Feb 2010, 02:04 PM (GMT -5)", "text": "Noted.", "source_page": 5}, {"entry_tracking_id": "541563", "comment_index": 4, "author": "Kristine Tinsley", "commented_at": "11 Feb 2010, 12:53 PM (GMT -5)", "text": "Acknowledged", "source_page": 5}, {"entry_tracking_id": "541563", "comment_index": 5, "author": "Trisha Hunt", "commented_at": "11 Feb 2010, 11:33 AM (GMT -5)", "text": "Subject lost diary for weeks 10-16. This diary was never returned to the site. Diary pages will be marked blank.", "source_page": 5}, {"entry_tracking_id": "521002", "comment_index": 1, "author": "William Lewis", "commented_at": "09 Dec 2009, 03:38 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 5}, {"entry_tracking_id": "521002", "comment_index": 2, "author": "William Lewis", "commented_at": "09 Dec 2009, 03:38 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 6}, {"entry_tracking_id": "521002", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "09 Dec 2009, 03:23 PM (GMT -5)", "text": "Subject R5013 inadvertently completed her diaries from Week 1 - Week 6 on a daily basis (e.g. Week 1 Diary date 7/13/09, Week 2 Diary date 7/14/09, Week 3 Diary date 7/15/09).\nStaff were able to salvage Week 1 and 2 data by taking the 7 days of data for the week and averaging it to obtain average number of cigarettes smoked and product used. The source was transcribed and stapled to her original daily dairies.\nHowever, starting with Week 17 diary, the information gathered changes, the diary did not request the product usage information or the adverse events. Since the subject used all of the diaries through Week 28 (and then photocopied the Week 28 diary to continue her diary entry), she hand wrote the amount of product used on the bottom of the diaries that did not request this information. Staff has averaged those amounts up to create a weekly diary. While product usage can be collected, the adverse event question is missing from all diaries Week 3 forward.\nIn discussion with the subject, she informed staff that if she had an AE, she would have written it in the blank space at the bottom of the diary as she did the product usage. On a few diaries, subject wrote \"have reported\" in which she informed me this meant she did have an AE and that she reported it to the clinic staff. This note is to clarify that if there is not a note, there was not an adverse even experienced at that time.", "source_page": 6}, {"entry_tracking_id": "520679", "comment_index": 1, "author": "William Lewis", "commented_at": "09 Dec 2009, 08:46 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 6}, {"entry_tracking_id": "520679", "comment_index": 2, "author": "William Lewis", "commented_at": "09 Dec 2009, 08:46 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 6}, {"entry_tracking_id": "520679", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "08 Dec 2009, 05:06 PM (GMT -5)", "text": "During the week 6 visit for R5011, the Minnesota Test was not performed in error.", "source_page": 6}, {"entry_tracking_id": "519003", "comment_index": 1, "author": "David Carter", "commented_at": "16 Feb 2010, 06:33 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 6}, {"entry_tracking_id": "519003", "comment_index": 2, "author": "David Carter", "commented_at": "16 Feb 2010, 06:33 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 6}, {"entry_tracking_id": "519003", "comment_index": 3, "author": "David Carter", "commented_at": "16 Feb 2010, 06:33 PM (GMT -5)", "text": "Noted.", "source_page": 6}, {"entry_tracking_id": "519003", "comment_index": 4, "author": "Laura Vol", "commented_at": "03 Dec 2009, 12:56 PM (GMT -5)", "text": "Subject(b)/2022 missed Week 20 phone visit on 25 Nov 2009 due to being out of\nstate for a job. Study coordinator completed Week 20 phone visit on 03 Dec 2009\nwhich leaves the subject out of the +/- 7 day window period.", "source_page": 6}, {"entry_tracking_id": "486528", "comment_index": 1, "author": "David Carter", "commented_at": "02 Sep 2009, 10:24 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 7}, {"entry_tracking_id": "486528", "comment_index": 2, "author": "David Carter", "commented_at": "02 Sep 2009, 10:24 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 7}, {"entry_tracking_id": "486528", "comment_index": 3, "author": "David Carter", "commented_at": "02 Sep 2009, 10:24 AM (GMT -5)", "text": "Noted.", "source_page": 7}, {"entry_tracking_id": "486528", "comment_index": 4, "author": "Laura Vol", "commented_at": "01 Sep 2009, 02:05 PM (GMT -5)", "text": "Study staff instructed subject at week 13 phone visit to fast 8 hours for Week 16 visit\non 01 Sep 2009. Subject stated his last meal was on 01 Sep 2009 at 06:00. Study staff in\nerror drew the subject's blood at 13:02 leaving the subject out of the 8 hour fasting time\nby 58 minutes. Progress note has been documented in subject's binder and source\ndocuments.", "source_page": 7}, {"entry_tracking_id": "486183", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:34 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 7}, {"entry_tracking_id": "486183", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:34 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 7}, {"entry_tracking_id": "486183", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:45 PM (GMT -5)", "text": "Subject(b))/3018 completed the week 16 visit 12 days out of window on 25Aug2009.\nSubject had to leave town suddenly and was unable to get a flight before the visit was\nalready out of window. Subject was again counseled on the importance of completing\nthe visits as scheduled. The subject stated that the trip was unavoidable.", "source_page": 7}, {"entry_tracking_id": "486182", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:37 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 7}, {"entry_tracking_id": "486182", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:37 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 7}, {"entry_tracking_id": "486182", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:39 PM (GMT -5)", "text": "Subject (b) /3018 completed his week 10 visit 15 days out of the scheduled window, and therefore the week 13 visit was missed. The week 13 call was scheduled to be on 15Jul2009, but the subject completed the week 10 visit on 13Jul2009. To allow the subject to get back on schedule with visits, the week 13 call was missed.", "source_page": 7}, {"entry_tracking_id": "486181", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:39 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 8}, {"entry_tracking_id": "486181", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:39 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 8}, {"entry_tracking_id": "486181", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:36 PM (GMT -5)", "text": "Subject (b) /3018 completed his week 10 visit 15 days out of window. Subject was unable to complete the visit due to a scheduling conflict with his work. The week 10 visit was rescheduled several times to accomidate the subject's schedule. Subject was counseled on the importance of completing visits as scheduled.", "source_page": 8}, {"entry_tracking_id": "486180", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:45 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 8}, {"entry_tracking_id": "486180", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:45 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 8}, {"entry_tracking_id": "486180", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:31 PM (GMT -5)", "text": "Subject was out of town and unable to complete the visit as scheduled. Subject completed the week 6 visit on 01Jun2009, 1 day out of window.", "source_page": 8}, {"entry_tracking_id": "486179", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:46 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 8}, {"entry_tracking_id": "486179", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:46 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 8}, {"entry_tracking_id": "486179", "comment_index": 3, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:46 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 8}, {"entry_tracking_id": "486179", "comment_index": 4, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:46 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 8}, {"entry_tracking_id": "486179", "comment_index": 5, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:28 PM (GMT -5)", "text": "Subject (b) /3029 completed the week 8 call 6 days out of window due to a scheduling conflict.", "source_page": 8}, {"entry_tracking_id": "486178", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:47 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 8}, {"entry_tracking_id": "486178", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:47 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 8}, {"entry_tracking_id": "486178", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:26 PM (GMT -5)", "text": "Due to previous scheduling issues with subject 3031/(b) the week 13 call was missed to allow the subject to finish out the rest of her visits for the study within the visit windows allowed per protocol.", "source_page": 9}, {"entry_tracking_id": "486176", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:49 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 9}, {"entry_tracking_id": "486176", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:49 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 9}, {"entry_tracking_id": "486176", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:23 PM (GMT -5)", "text": "Subject 3031(b) completed the week 10 visit 18 days out of window due to previous error. Subject was expected to miss the week 8 call so that the week 10 visit would be within the visit window. This was an oversite by staff.", "source_page": 9}, {"entry_tracking_id": "486174", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:50 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 9}, {"entry_tracking_id": "486174", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:50 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 9}, {"entry_tracking_id": "486174", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:20 PM (GMT -5)", "text": "Subject's week 8 call was completed 13 days out of window. Per previous progress note the week 8 call was to be a missed visit to get the subject back on schedule for the study, however, the staff completing visits at that time did not see the note and completed the week 8 call.", "source_page": 9}, {"entry_tracking_id": "486173", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:51 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 9}, {"entry_tracking_id": "486173", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:51 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 9}, {"entry_tracking_id": "486170", "comment_index": 1, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:16 PM (GMT -5)", "text": "Subject(b)/3031 completed the week 6 visit 13 days out of window due to a scheduling conflict.", "source_page": 9}, {"entry_tracking_id": "486170", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:54 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 9}, {"entry_tracking_id": "486170", "comment_index": 3, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:54 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 9}, {"entry_tracking_id": "486169", "comment_index": 1, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:06 PM (GMT -5)", "text": "Due to schedule conflict subject(b)/3022 completed his week 10 visit 4 days out of window. Subject was counseled on importance of completing visits as scheduled.", "source_page": 10}, {"entry_tracking_id": "486169", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:55 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 10}, {"entry_tracking_id": "486169", "comment_index": 3, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:55 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 10}, {"entry_tracking_id": "484319", "comment_index": 1, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:03 PM (GMT -5)", "text": "Due to a staff scheduling error subject(b)/3022 completed his week 13 visit 7 days out of window. A new calander has been provided to appropriate staff to avoid future errors.", "source_page": 10}, {"entry_tracking_id": "484319", "comment_index": 2, "author": "Harry Farmer", "commented_at": "27 Aug 2009, 08:59 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 10}, {"entry_tracking_id": "484319", "comment_index": 3, "author": "Harry Farmer", "commented_at": "27 Aug 2009, 08:59 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 10}, {"entry_tracking_id": "484319", "comment_index": 4, "author": "Yvette Taylor", "commented_at": "27 Aug 2009, 07:44 AM (GMT -5)", "text": "Study Coordinator and Regulatory Specialist need to determine if this is reportable to the IRB.", "source_page": 10}, {"entry_tracking_id": "484319", "comment_index": 5, "author": "Christina Breedlove", "commented_at": "25 Aug 2009, 03:14 PM (GMT -5)", "text": "Per the Protocol; Subjects are allowed to use Study Product from Baseline up to Week 16. Week 16 visit has a (+/- 1 wk) window. However, there is no window for product use.\n\nSubject #1015 discontinued product use on 23-Aug-2009, an additional 6 days more than allowed by the protocol.", "source_page": 10}, {"entry_tracking_id": "481013", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:56 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 10}, {"entry_tracking_id": "481013", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:56 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 10}, {"entry_tracking_id": "481013", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "14 Aug 2009, 02:47 PM (GMT -5)", "text": "During the Early Termination visit subject(b) 3015 failed to complete the FTND due to a staff oversight. The appropriate staff have reviewed the protocol to avoid furture error.", "source_page": 10}, {"entry_tracking_id": "461545", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:57 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 11}, {"entry_tracking_id": "461545", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:57 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 11}, {"entry_tracking_id": "461545", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "18 Jun 2009, 10:14 AM (GMT -5)", "text": "Subject(b)/3015 failed to complete Fagerstrom Test for Nicotine Dependence at the early term visit.", "source_page": 11}, {"entry_tracking_id": "458680", "comment_index": 1, "author": "Keith Klatt", "commented_at": "20 Jul 2009, 01:13 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 11}, {"entry_tracking_id": "458680", "comment_index": 2, "author": "Keith Klatt", "commented_at": "20 Jul 2009, 01:13 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 11}, {"entry_tracking_id": "458680", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "10 Jun 2009, 02:12 PM (GMT -5)", "text": "Subject(b) 3001 did not complete the week 13 phone contact within window. Subject completed call 1 day out of window. Subject was counseled regarding importance of visit window to avoid future issues.", "source_page": 11}, {"entry_tracking_id": "567211", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "22 Apr 2010, 09:52 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 12}, {"entry_tracking_id": "567211", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "22 Apr 2010, 09:52 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 12}, {"entry_tracking_id": "567211", "comment_index": 3, "author": "Faye Terry", "commented_at": "21 Apr 2010, 03:16 PM (GMT -5)", "text": "Study # 7694-105\nRE: Outside of Window Visit (Screenig)\nRE: Rand# 4093\nThe above-referenced subject was 42 days outside of the screening window. The screen visit was on 26 May 2009. The baseline visit was on 08 Jul 2009.", "source_page": 12}, {"entry_tracking_id": "567177", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "22 Apr 2010, 09:56 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 12}, {"entry_tracking_id": "567177", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "22 Apr 2010, 09:56 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.\n4118 13 22 Oct 2009 12 Nov 2009 18 days\n4119 28 04 Feb 2010 16 Feb 2010 9 days\n4100 2 22 Jul 2009 27 Jul 2009 2 days\n4099 2 22 Jul 2009 27 Jul 2009 2 days\n4099 24 23 Dec 2009 18 Dec 2009 2 days\n4099 28 20 Jan 2010 02 Feb 2010 10 days\n4133 2 06 Aug 2009 10 Aug 2009 1 day\n4109 4 20 Aug 2009 27 Aug 2009 4 days\n4103 3 31 Jul 2009 20 Aug 2009 17 days\n4103 4 07 Aug 2009 27 Aug 2009 17 days\n4102 2 22 Jul 2009 27 Jul 2009 2 days\n4102 24 23 Dec 2009 06 Jan 2010 11 days\n4107 2 06 Aug 2009 10 Aug 2009 1 day\n4093 20 25 Nov 2009 28 Oct 2009 28 days (early)\n4093 24 23 Dec 2009 11 Jan 2010 16 days\n4108 8 17 Sep 2009 24 Sep 2009 4 days\n4101 1 15 Jul 2009 20 Jul 2009 2 days\n4101 2 22 Jul 2009 27 Jul 2009 2 days\n4094 2 22 Jul 2009 28 Jul 2009 3 days\n4094 24 23 Dec 2009 23 Jan 2010 28 days\n4092 1 09 Jul 2009 15 Jul 2009 3 days\n4092 2 16 Jul 2009 24 Jul 2009 5 days\n4092 3 23 Jul 2009 30 Jul 2009 4 days\n4092 4 30 Jul 2009 18 Aug 2009 15 days\n4092 6 13 Aug 2009 18 Aug 2009 2 days\n4092 8 27 Aug 2009 31 Aug 2009 1 day\n4092 13 01 Oct 2009 14 Oct 2009 10 days\n4092 16 22 Oct 2009 28 Dec 2009 3 days\n4092 20 19 Nov 2009 08 Jan 2010 16 days\n4092 28 14 Jan 2010 20 Jan 2010 3 days\n4097 2 22 Jul 2009 27 Jul 2009 2 days\n4097 20 25 Nov 2009 15 Dec 2009 17 days\n4097 24 23 Dec 2009 14 Jan 2010 19 days\n4096 1 15 Jul 2009 20 Jul 2009 2 days\n4096 2 22 Jul 2009 27 Jul 2009 2 days\n4096 20 25 Nov 2009 08 Dec 2009 10 days\n4096 24 23 Dec 2009 23 Feb 2010 28 days\n4096 28 20 Jan 2010 23 Feb 2010 31 days\n4033 2 11 May 2009 18 May 2009 4 days\n4029 28 05 Nov 2009 12 Nov 2009 4 days\n4057 3 02 Jul 2009 06 Jul 2009 1 day\n4057 6 23 Jul 2009 31 Jul 2009 5 days\n4057 16 01 Oct 2009 09 Oct 2009 5 days\n4057 24 26 Nov 2009 21 Jan 2010 53 days\n4057 28 24 Dec 2009 21 Jan 2010 25 days\n4027 20 02 Sep 2009 23 Sep 2009 18 days\n4053 6 14 Jul 2009 30 Jul 2009 13 days\n4059 4 09 Jul 2009 11 Aug 2009 30 days\n4072 1 03 Jul 2009 07 Jul 2009 1 day\n4072 16 16 Oct 2009 22 Oct 2009 3 days\n4087 1 09 Jul 2009 13 Jul 2009 1 day\n4087 6 13 Aug 2009 24 Aug 2009 8 days\n4087 8 27 Aug 2009 17 Sep 2009 18 days\n4087 10 10 Sep 2009 23 Sep 2009 10 days\n4070 6 07 Aug 2009 12 Aug 2009 2 days\n4070 13 25 Sep 2009 01 Oct 2009 4 days\n4070 28 08 Jan 2010 18 Feb 2010 38 days\n4069 10 01 Sep 2009 09 Sep 2009 5 days\n4089 3 23 Jul 2009 27 Jul 2009 1 day\n4089 6 13 Aug 2009 10 Sep 2009 25 days\n4089 8 27 Aug 2009 21 Sep 2009 22 days\n4089 10 10 Sep 2009 24 Sep 2009 11 days\n4084 6 12 Aug 2009 17 Aug 2009 2 days\n4084 8 26 Aug 2009 11 Sep 2009 13 days\n4083 13 28 Sep 2009 05 Oct 2009 4 days\n4075 6 10 Aug 2009 14 Aug 2009 1 day\n4088 3 23 Jul 2009 27 Jul 2009 1 day\n4076 6 10 Aug 2009 18 Aug 2009 5 days\n4079 16 19 Oct 2009 04 Nov 2009 13 days\n4079 24 14 Dec 2009 18 Nov 2009 23 days (early)\n4077 10 07 Sep 2009 31 Aug 2009 5 days\n4055 20 22 Oct 2009 26 Oct 2009 1 day\n4068 8 14 Aug 2009 20 Aug 2009 3 days\n4068 16 09 Oct 2009 16 Oct 2009 4 days\n4068 28 04 Jan 2010 08 Jan 2010 1 day\nThe following subjects were early terminations; therefore, the visits are not outside of the window:\n- Rand#4014\n- Rand#4098\nAn Enote was generated for the above-referenced subjects (#4014 and #4098) as documentation that the visits were outside of the window; however, this is an updated Enote to clarify that early termination subjects visits are not considered to be outside of the window.", "source_page": 12}, {"entry_tracking_id": "560703", "comment_index": 1, "author": "Harry Farmer", "commented_at": "06 Apr 2010, 12:20 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 14}, {"entry_tracking_id": "560703", "comment_index": 2, "author": "Harry Farmer", "commented_at": "06 Apr 2010, 12:20 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 14}, {"entry_tracking_id": "560703", "comment_index": 3, "author": "Yvette Taylor", "commented_at": "06 Apr 2010, 12:11 PM (GMT -5)", "text": "Corrective action referenced in previous comment.", "source_page": 14}, {"entry_tracking_id": "560703", "comment_index": 4, "author": "Christina Breedlove", "commented_at": "05 Apr 2010, 09:49 AM (GMT -5)", "text": "This NTF is to clarify how subject #1010 dated their weekly diaries for weeks 17 thru week 28. When the subject reported for their Final Visit/Week 28, on 06Oct2009, they had all data recorded for each week, but did not have the \"Date of Completion\" line filled out on their weekly diaries. The subject was confused as to which date they were to record, (the beginning of the week or the end of the week).\n\nDuring the clinic visit on 06/Oct/2009, Subject #1010, made a late entry and entered the dates from their study calendar in the \"Date of Completion\" line, for each weekly diary , for Weeks 17 thru Week 28. For each late entry the subject included their initials and the date of entry which was 10-6-09.", "source_page": 14}, {"entry_tracking_id": "551110", "comment_index": 1, "author": "William Lewis", "commented_at": "09 Mar 2010, 09:11 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 14}, {"entry_tracking_id": "551110", "comment_index": 2, "author": "William Lewis", "commented_at": "09 Mar 2010, 09:11 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 14}, {"entry_tracking_id": "551110", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "09 Mar 2010, 09:06 AM (GMT -5)", "text": "This note to file serves to document the protocol deviations for subject #5025.\n\n-There is no documentation regarding the week 13 phone call being completed.\n\n-When the subject returned for the week 28 visit, he returned blank diaries for weeks 19-27. The subject reported that he is still smoking as of his Week 28 visit.", "source_page": 14}, {"entry_tracking_id": "548143", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "01 Mar 2010, 04:58 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 15}, {"entry_tracking_id": "548143", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "01 Mar 2010, 04:58 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 15}, {"entry_tracking_id": "548143", "comment_index": 3, "author": "Faye Terry", "commented_at": "01 Mar 2010, 01:44 PM (GMT -5)", "text": "RE: Information Session at the Screen Visit\nRandomization # - 4065\n\nThe information session at the screen visit was not signed by staff to verify completion of this procedure. However, the purpose and nature of the study was explained to the subject and the staff did sign-off on this procedure. And, the clean-air booklet was dispensed to the subject and the staff did sign-off on this procedure.", "source_page": 15}, {"entry_tracking_id": "542864", "comment_index": 1, "author": "Harry Farmer", "commented_at": "16 Feb 2010, 12:45 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 15}, {"entry_tracking_id": "542864", "comment_index": 2, "author": "Harry Farmer", "commented_at": "16 Feb 2010, 12:45 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 15}, {"entry_tracking_id": "542864", "comment_index": 3, "author": "Yvette Taylor", "commented_at": "16 Feb 2010, 10:11 AM (GMT -5)", "text": "No additional comments.", "source_page": 15}, {"entry_tracking_id": "542864", "comment_index": 4, "author": "Christina Breedlove", "commented_at": "15 Feb 2010, 05:29 PM (GMT -5)", "text": "Per the protocol subjects that have received study product will come to the clinic for evaluation on Weeks 6, 10, 16 and 28.\n\nThe following subjects were unavailable for clinic visits and subsequently were out-of-window one or more days, for their scheduled clinic visits; (b) #1012, WK 10-1 day out of window & WK 16-11 days out of window, (b) #1018, WK 6-1 day out of window, (b) #1019, WK 10-3 days out of window, & WK 16-1 day out of window, (b) #1022, WK 28-1 day out of window, (b) #1028, WK 10-7 days out of window & WK 28-8 days out of window, (b) #1031, WK 6-1 day out of window & WK 10-8 days out of window, (b) #1037, WK 6-7 days out of window.", "source_page": 15}, {"entry_tracking_id": "539288", "comment_index": 1, "author": "Harry Farmer", "commented_at": "08 Feb 2010, 09:02 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 15}, {"entry_tracking_id": "539288", "comment_index": 2, "author": "Harry Farmer", "commented_at": "08 Feb 2010, 09:02 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 15}, {"entry_tracking_id": "539288", "comment_index": 3, "author": "Yvette Taylor", "commented_at": "05 Feb 2010, 08:59 AM (GMT -5)", "text": "No corrective action indicated.", "source_page": 16}, {"entry_tracking_id": "539288", "comment_index": 4, "author": "Christina Breedlove", "commented_at": "04 Feb 2010, 01:14 PM (GMT -5)", "text": "Per the Protocol, telephone contacts will occur at weeks 1 thru 4, 8 & 13, to review the subject's smoking status, use of study products, brief behavioral counseling and assess any Adverse Events. Telephone contacts will also be made at weeks 20 & 24 to assess any Adverse Events, review the subject's smoking status and to provide brief behavioral counseling.\n\nThe following subjects were unavailable for contact and subsequently were out-of-window one or more days, for their Follow-up telephone calls; (b) #1011 WK 8 was 1 day out of window, (b) #1012, WK 8 was 3 days out of window & WK 13 was 3 days out of window, (b) #1020, WK 8 was 1 day out of window, (b) #1021 WK 2 was 1 day out of window, (b) #1030, WK 3 was 1 day out of window, & WK 8 was 4 days out of window, (b) #1031, WK 8 was 1 day out of window, (b) #1032, WK 1 was 2 days out of window, (b) #1036, WK 8 was 1 day out of window & WK 13 was 2 days out of window.", "source_page": 16}, {"entry_tracking_id": "536303", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:17 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 16}, {"entry_tracking_id": "536303", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:17 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 16}, {"entry_tracking_id": "536303", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:57 AM (GMT -5)", "text": "Randomization number 4018 completed the week 13 visit outside of the window visit - +/- 3 days. The expected date of the visit was 12 Jun 2009 and the visit occurred on 17 Jun 2009 - 2 days outside of the window visit.", "source_page": 16}, {"entry_tracking_id": "536300", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:17 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 16}, {"entry_tracking_id": "536300", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:17 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 16}, {"entry_tracking_id": "536300", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:54 AM (GMT -5)", "text": "Randomization number 4017 completed the week 13 visit outside of the window visit - +/- 3 days. The expected date of the visit was 12 Jun 2009 and the visit occurred on 17 Jun 2009 - 2 days outside of the window visit.", "source_page": 16}, {"entry_tracking_id": "536296", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:18 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 16}, {"entry_tracking_id": "536296", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:18 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 17}, {"entry_tracking_id": "536296", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:51 AM (GMT -5)", "text": "Randomization number 4016 completed the week 13 visit outside of the window visit - +/- 3 days. The expected date of the visit was 12 Jun 2009 and the visit occurred on 17 Jun 2009 - 2 days outside of the window visit.", "source_page": 17}, {"entry_tracking_id": "536284", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:21 PM (GMT -5)", "text": "Impact: as above", "source_page": 17}, {"entry_tracking_id": "536284", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:21 PM (GMT -5)", "text": "Corrective Action: please verify dates", "source_page": 17}, {"entry_tracking_id": "536284", "comment_index": 3, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:20 PM (GMT -5)", "text": "expected date does not correlate", "source_page": 17}, {"entry_tracking_id": "536284", "comment_index": 4, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:45 AM (GMT -5)", "text": "Randomization number 4014 completed the week 28 visit outside of the window visit - +/- 3 days. The expected date of the visit was 23 Sep 2009 and the visit occurred on 06 Jul 2009 - 10 days outside of the window visit.", "source_page": 17}, {"entry_tracking_id": "536278", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:22 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 17}, {"entry_tracking_id": "536278", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:22 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 17}, {"entry_tracking_id": "536278", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:43 AM (GMT -5)", "text": "Randomization number 4007 completed the week 28 visit outside of the window visit - +/- 3 days. The expected date of the visit was 23 Sep 2009 and the visit occurred on 29 Sep 2009 - 3 days outside of the window visit.", "source_page": 17}, {"entry_tracking_id": "536272", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:23 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 17}, {"entry_tracking_id": "536272", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:23 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 17}, {"entry_tracking_id": "536272", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:39 AM (GMT -5)", "text": "Randomization number 4011 completed the week 24 visit outside of the window visit - +/- 3 days. The expected date of the visit was 26 Aug 2009 and the visit occurred on 02 Sep 2009 - 4 days outside of the window visit.", "source_page": 18}, {"entry_tracking_id": "536267", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:25 PM (GMT -5)", "text": "Impact: significant delay in visit noted", "source_page": 18}, {"entry_tracking_id": "536267", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:25 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 18}, {"entry_tracking_id": "536267", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:35 AM (GMT -5)", "text": "Randomization number 4011 completed the week 16 visit outside of the window visit - +/- 3 days. The expected date of the visit was 01 Jul 2009 and the visit occurred on 29 Jul 2009 - 25 days outside of the window visit.", "source_page": 18}, {"entry_tracking_id": "536261", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:27 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 18}, {"entry_tracking_id": "536261", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:27 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 18}, {"entry_tracking_id": "536261", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:32 AM (GMT -5)", "text": "Randomization number 4010 completed the week 16 visit outside of the window visit - +/3 days. The expected date of the visit was 01 Jul 2009 and the visit occurred on 07 Jul 2009 - 3 days outside of the window visit.", "source_page": 18}, {"entry_tracking_id": "536252", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:29 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 18}, {"entry_tracking_id": "536252", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:29 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 18}, {"entry_tracking_id": "536252", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:27 AM (GMT -5)", "text": "Randomization number 4007 completed the week 16 visit outside of the window visit - +/- 3 days. The expected date of the visit was 01 Jul 2009 and the visit occurred on 07 Jul 2009 - 4 days outside of the window visit.", "source_page": 18}, {"entry_tracking_id": "536246", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:31 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 18}, {"entry_tracking_id": "536246", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:31 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 19}, {"entry_tracking_id": "536246", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:22 AM (GMT -5)", "text": "Randomization number 4014 completed the week 13 visit outside of the window visit -(+/- 3 days). The expected date of the visit was 10 Jun 2009 and the actual date of the visit was 15 Jun 2009 - 2 days outside of the window visit.", "source_page": 19}, {"entry_tracking_id": "536243", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:33 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 19}, {"entry_tracking_id": "536243", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:33 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 19}, {"entry_tracking_id": "536243", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:18 AM (GMT -5)", "text": "Randomization number 4007 completed the week 13 visit outside of the window visit - (+/- 3 days). The expected date of the visit was 10 Jun 2009 and the actual date of the visit occurred on 18 Jun 2009 - 5 days outside of the window visit.", "source_page": 19}, {"entry_tracking_id": "536237", "comment_index": 1, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:34 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 19}, {"entry_tracking_id": "536237", "comment_index": 2, "author": "Randall Stoltz", "commented_at": "27 Jan 2010, 12:34 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 19}, {"entry_tracking_id": "536237", "comment_index": 3, "author": "Faye Terry", "commented_at": "27 Jan 2010, 11:14 AM (GMT -5)", "text": "Randomization number 4007 completed the week 10 visit outside of the window visit (+/-) 3 days. The expected date of the visit was 20 May 2009 and the visit occurred on 26 May 2009 - 3 days outside of the window visit.", "source_page": 19}, {"entry_tracking_id": "531726", "comment_index": 1, "author": "William Lewis", "commented_at": "14 Jan 2010, 12:32 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 19}, {"entry_tracking_id": "531726", "comment_index": 2, "author": "William Lewis", "commented_at": "14 Jan 2010, 12:32 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 19}, {"entry_tracking_id": "531726", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "14 Jan 2010, 11:41 AM (GMT -5)", "text": "In error, no week 1 phone call was completed for the above referenced subject. In reviewing the call logs, no documentation is available for any attempts. The site implemented a new call log to track attempts and contacts. The study team actively reviews these logs weekly.", "source_page": 19}, {"entry_tracking_id": "531331", "comment_index": 1, "author": "William Lewis", "commented_at": "13 Jan 2010, 02:30 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 20}, {"entry_tracking_id": "531331", "comment_index": 2, "author": "William Lewis", "commented_at": "13 Jan 2010, 02:30 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 20}, {"entry_tracking_id": "531331", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "13 Jan 2010, 02:26 PM (GMT -5)", "text": "Subject R5009 returned to the clinic to perform his Early Termination Visit. In error, the team did not collect his Fagerstrom and Minnesota questionnaire at this time. This memo is to document the deviation.", "source_page": 20}, {"entry_tracking_id": "531309", "comment_index": 1, "author": "William Lewis", "commented_at": "13 Jan 2010, 02:18 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 20}, {"entry_tracking_id": "531309", "comment_index": 2, "author": "William Lewis", "commented_at": "13 Jan 2010, 02:18 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 20}, {"entry_tracking_id": "531309", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "13 Jan 2010, 02:03 PM (GMT -5)", "text": "In error, no week 1 phone call was completed for the above referenced subjects. In reviewing the call logs, no documentation is available for any attempts. The site implemented a new call log to track attempts and contacts. The study team actively reviews these logs weekly.", "source_page": 20}, {"entry_tracking_id": "527283", "comment_index": 1, "author": "David Carter", "commented_at": "04 Jan 2010, 08:36 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 20}, {"entry_tracking_id": "527283", "comment_index": 2, "author": "David Carter", "commented_at": "04 Jan 2010, 08:36 AM (GMT -5)", "text": "Corrective Action: As written.", "source_page": 20}, {"entry_tracking_id": "527283", "comment_index": 3, "author": "David Carter", "commented_at": "04 Jan 2010, 08:34 AM (GMT -5)", "text": "Noted.", "source_page": 20}, {"entry_tracking_id": "527283", "comment_index": 4, "author": "Laura Vol", "commented_at": "30 Dec 2009, 03:09 PM (GMT -5)", "text": "Subject(b) /2022 missed her scheduled Week 20 phone visit on 20 Nov 2009. Subject contacted site to complete phone visit on 03 Dec 2009 leaving her out of the +/- 7 day window period.", "source_page": 20}, {"entry_tracking_id": "527280", "comment_index": 1, "author": "David Carter", "commented_at": "04 Jan 2010, 08:37 AM (GMT -5)", "text": "Corrective Action: As written.", "source_page": 20}, {"entry_tracking_id": "527280", "comment_index": 2, "author": "David Carter", "commented_at": "04 Jan 2010, 08:37 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 20}, {"entry_tracking_id": "527280", "comment_index": 3, "author": "David Carter", "commented_at": "04 Jan 2010, 08:37 AM (GMT -5)", "text": "Noted.", "source_page": 21}, {"entry_tracking_id": "527280", "comment_index": 4, "author": "Laura Vol", "commented_at": "30 Dec 2009, 03:02 PM (GMT -5)", "text": "Subject(b) /2022 missed her Week 24 visit that was scheduled on 18 Dec 2009. Subject contacted site on 30 Dec 2009 to complete the phone visit therefore subject is out of the +/- 7 day window period.", "source_page": 21}, {"entry_tracking_id": "510840", "comment_index": 1, "author": "David Carter", "commented_at": "16 Nov 2009, 12:05 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 21}, {"entry_tracking_id": "510840", "comment_index": 2, "author": "David Carter", "commented_at": "16 Nov 2009, 12:05 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 21}, {"entry_tracking_id": "502029", "comment_index": 1, "author": "David Carter", "commented_at": "16 Nov 2009, 12:05 PM (GMT -5)", "text": "See attached source. I could find no documentation of review on 10 Nov. Review was signed off on 16 Nov 2009.", "source_page": 21}, {"entry_tracking_id": "502029", "comment_index": 2, "author": "Laura Vol", "commented_at": "10 Nov 2009, 04:59 PM (GMT -5)", "text": "At Week 10 visit on 18 Sep 2009 for subject(b) /2022 the systolic blood pressure was out of range. Repeat was not performed due to staff error. Out of range vital signs were not assessed by the investigator(s) until 10 Nov 2009. Please refer to page 2 of 4 of Week 10 visit source documents.", "source_page": 21}, {"entry_tracking_id": "502029", "comment_index": 3, "author": "Harry Farmer", "commented_at": "19 Oct 2009, 08:05 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 21}, {"entry_tracking_id": "502029", "comment_index": 4, "author": "Harry Farmer", "commented_at": "19 Oct 2009, 08:05 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 21}, {"entry_tracking_id": "502029", "comment_index": 5, "author": "Yvette Taylor", "commented_at": "19 Oct 2009, 07:42 AM (GMT -5)", "text": "No corrective action indicated.", "source_page": 21}, {"entry_tracking_id": "502029", "comment_index": 6, "author": "Christina Breedlove", "commented_at": "16 Oct 2009, 01:39 PM (GMT -5)", "text": "This note to file is to clarify that the subject did not complete a weekly diary for Week 6 and misdated the following diaries for Week 7 thru Week 9.\n\nThe subject entered their Week 6 diary information, on their Week 7 diary, dated 04/26/09. They entered their Week 7 diary information on their Week 8 diary, dated 03/May/09 Also, they entered their Week 8 diary information, on their Week 9 diary dated 10/May/09.\n\nThis was confirmed on 07/Oct/2009 with the monitor and the subject's entries of \"dates of completion\".", "source_page": 21}, {"entry_tracking_id": "480138", "comment_index": 1, "author": "Harry Farmer", "commented_at": "17 Aug 2009, 05:57 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 22}, {"entry_tracking_id": "480138", "comment_index": 2, "author": "Harry Farmer", "commented_at": "17 Aug 2009, 05:57 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 22}, {"entry_tracking_id": "480138", "comment_index": 3, "author": "Yvette Taylor", "commented_at": "14 Aug 2009, 06:40 PM (GMT -5)", "text": "Error reviewed with responsible staff member. Reminded to review and adhere to protocol requirements when performing procedures.", "source_page": 22}, {"entry_tracking_id": "480138", "comment_index": 4, "author": "Christina Breedlove", "commented_at": "12 Aug 2009, 04:13 PM (GMT -5)", "text": "Re: Subject #1002 ((b) Subject's weight was not taken at Week 10 visit, in error. Per the Protocol, subject's body weight is to be taken whenever vital signs are taken.", "source_page": 22}, {"entry_tracking_id": "480126", "comment_index": 1, "author": "Harry Farmer", "commented_at": "17 Aug 2009, 05:55 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 22}, {"entry_tracking_id": "480126", "comment_index": 2, "author": "Harry Farmer", "commented_at": "17 Aug 2009, 05:55 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 22}, {"entry_tracking_id": "480126", "comment_index": 3, "author": "Yvette Taylor", "commented_at": "14 Aug 2009, 06:36 PM (GMT -5)", "text": "Error reviewed with responsible staff member. Reminded to adhere to timing in protocol when performing procedures.", "source_page": 22}, {"entry_tracking_id": "480126", "comment_index": 4, "author": "Christina Breedlove", "commented_at": "12 Aug 2009, 03:56 PM (GMT -5)", "text": "Subject #1020(b) was only seated (1) minute prior to vitals being taken at week 6 visit. Per the protocol, subjects must be seated for (5) minutes prior to vitals.", "source_page": 22}, {"entry_tracking_id": "431526", "comment_index": 1, "author": "Harry Farmer", "commented_at": "23 Mar 2009, 08:35 AM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 22}, {"entry_tracking_id": "431526", "comment_index": 2, "author": "Harry Farmer", "commented_at": "23 Mar 2009, 08:35 AM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 22}, {"entry_tracking_id": "431526", "comment_index": 3, "author": "Yvette Taylor", "commented_at": "20 Mar 2009, 02:55 PM (GMT -5)", "text": "Reviewed 20Mar2009 Y. Taylor - No corrective action recommended.", "source_page": 22}, {"entry_tracking_id": "431526", "comment_index": 4, "author": "Christina Breedlove", "commented_at": "20 Mar 2009, 02:51 PM (GMT -5)", "text": "Subject #01002(b) was only seated (1) minute prior to screening vitals. Per the protocol, subjects must be seated for (5) minutes prior to vitals.", "source_page": 23}, {"entry_tracking_id": "486172", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:52 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 24}, {"entry_tracking_id": "486172", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:52 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 24}, {"entry_tracking_id": "486172", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:13 PM (GMT -5)", "text": "Due to subject's week 6 visit being out of window subject 3031(b) did not complete diary pages at week 6 or 7.", "source_page": 24}, {"entry_tracking_id": "486171", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:52 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 24}, {"entry_tracking_id": "486171", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:52 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 24}, {"entry_tracking_id": "486171", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:09 PM (GMT -5)", "text": "Due to staff error a return questionnaire was not completed for subject 3013(b) during the week 16 visits. Staff has been retrained to avoid future error.", "source_page": 24}, {"entry_tracking_id": "486168", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:55 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 24}, {"entry_tracking_id": "486168", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:55 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 24}, {"entry_tracking_id": "486168", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "31 Aug 2009, 10:00 PM (GMT -5)", "text": "Subject 3022(b) failed to complete the diary entries for weeks 10-16. Subject completed the entries during the week 16 visit and was re-educated on diary completion to avoid furture issue.", "source_page": 24}, {"entry_tracking_id": "481010", "comment_index": 1, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:58 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 24}, {"entry_tracking_id": "481010", "comment_index": 2, "author": "Keith Klatt", "commented_at": "01 Sep 2009, 12:58 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 24}, {"entry_tracking_id": "481010", "comment_index": 3, "author": "Trisha Hunt", "commented_at": "14 Aug 2009, 02:43 PM (GMT -5)", "text": "RE:3003(b)\n\nDue to staff error during the week 6 visit, the number of cigarettes smoked during the past week was not documented.", "source_page": 24}, {"entry_tracking_id": "580475", "comment_index": 1, "author": "William Lewis", "commented_at": "28 May 2010, 01:01 PM (GMT -5)", "text": "Corrective Action: Documentation of deviation serves as the corrective action.", "source_page": 25}, {"entry_tracking_id": "580475", "comment_index": 2, "author": "William Lewis", "commented_at": "28 May 2010, 01:01 PM (GMT -5)", "text": "Impact: No impact to study integrity apparent at this time.", "source_page": 25}, {"entry_tracking_id": "580475", "comment_index": 3, "author": "Adrienne Levandowski", "commented_at": "28 May 2010, 09:51 AM (GMT -5)", "text": "Subject #5010 returned to the clinic on 08Sep2009 to complete early termination events. Due to staff error, the Serum, EDTA, and Sodium Citrate Plasma were all placed in the freezer greater than 1 hour after collection. This deviation has been notated on the source.\n\nContinuing training on blood processing will occur for all staff members.", "source_page": 25}, {"entry_tracking_id": "501410", "comment_index": 1, "author": "Adrienne Levandowski", "commented_at": "15 Oct 2009, 10:19 AM (GMT -5)", "text": "Subject #R5023 returned on week 9 to complete her week 6 visit due to being unavailable. The staff member performing the event did not get the PD biomarker in error. Upon return to the clinic the following week, this marker was drawn (during week 10 visit).", "source_page": 26}]}