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CRF Report for Study E7694105Report run by Brian Saari at 06-MAR-2013 16:13:40
Abc 123
Abc 123
CD_001
All statuses
All statuses
R5020
R5020
All statuses
Report Parameters
Abc 123
Site:
Discrepancy status choice:
Approval status choice:
Verification status choice:
Legend: How different values appear in the report
The data contained in this report is current at the time of printing (time as shown above)All time stamps displayed in this report are in the timezone of the database server.
Starting patient:
Ending patient:
PromptData valueData value with discrepancy
02.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
03.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
04.OS.1
OverFlow Section For Document Number R259445213
LAST DENTAL CHECK-UP OVER 5 YEARS AGO1
04.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
09.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
10.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
14.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
16.OS.1
OverFlow Section For Document Number R265106013
MESSAGE WAS LEFT FOR SUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED1
MESSAGE WAS LEFT FOR SUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED2
MESSAGE WAS LEFT FOR SUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED3
16.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
17.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
18.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
20.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
21.OS.1
OverFlow Section For Document Number R275376013
UNABLE TO CONTACT AFTER 3 ATTEMPTS1
21.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
27.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
36.LINKS
Links to Discrepancy and Audit Sections
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39.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
39.1.U1.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
39.1.U3.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
39.1.U4.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
39.1.U5.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Click here to navigate to discrepancy details for this CRF
39.1.U6.LINKS
Links to Discrepancy and Audit Sections
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Click here to navigate to discrepancy details for this CRF
39.1.U7.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
40.LINKS
Links to Discrepancy and Audit Sections
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43.LINKS
Links to Discrepancy and Audit Sections
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Appendix: Audit and Discrepancy Information
Report run by Brian Saari at 06-MAR-2013 16:13:44 81Page
Report run by Brian Saari at 06-MAR-2013 16:13:44 82Page
Audit History Report
This section lists audited data that meets the parameters set when the report was run. It may not include all of the auditeddata in a particular CRF. Refer to the documentation for a complete description of the parameters that can affect this report.
Report run by Brian Saari at 06-MAR-2013 16:13:44 83Page
R259337813
Page_02
CD_001
R5020 Screening02
Ic Page number 2 Screening
IE
InclusionCriteria Answer6
YES
NO
04-DEC-2009 13:43:01
Sharon Ladenes
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 84Page
R259352813
Page_03
CD_001
R5020 Screening03
Ec Page number 3 Screening
IE
ExclusionCriteria Answer
ExclusionCriteria Answer
3
3
NO
YES
YES
NO
23-JUL-2009 18:15:00
04-DEC-2009 13:43:35
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 85Page
R259445213
Page_04
CD_001
R5020 Screening04
Elig Page number 4 Screening
IE
Category
Category
Did the subjectmeet all of theinclusio
ExemptionGranted?
Explanation (1)
If Yes, DateGranted
Inclusion/Exclusion No.
Inclusion/Exclusion No.
Inclusion/Exclusion No.
1
1
1
1
1
1
1
1
1
E
YES
03
06
E
I
NO
YES
LAST DENTAL CHECK-UPOVER 5 YEARS AGO
21-JUL-2009
03
06
6
23-JUL-2009 18:15:54
04-DEC-2009 13:44:06
23-JUL-2009 18:14:18
23-JUL-2009 18:15:54
23-JUL-2009 18:15:54
23-JUL-2009 18:15:54
23-JUL-2009 18:15:54
04-DEC-2009 13:44:06
17-MAR-2010 18:07:35
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Krysia Magnuson 06 to 6. KAY17Mar2010.
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Data Entry Error
ODM/SEC
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 86Page
R259447413
Page_09
CD_001
R5020 Screening09
Mh Page number 9 Screening
MH1
Date of Onset
Date of Onset
Date ofResolution
Date ofResolution
Diagnosis/Procedure
Diagnosis/Procedure
Ongoing
Ongoing
Sequence Number
Sequence Number
Date of Onset
Date of Onset
Date ofResolution
Date ofResolution
1
1
1
1
1
1
1
1
1
1
2
2
2
2
00-APR-2009
00-APR-2009
GALL BLADDER REMOVAL
1
00-MAY-2007
00-MAY-2007
<Row Deleted>
00-00-2007
<Row Deleted>
<Row Deleted>
OSTEOARTHRITIS
<Row Deleted>
CHECKED
<Row Deleted>
1
<Row Deleted>
00-00-1996
<Row Deleted>
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 87Page
R259447413
Page_09
CD_001
R5020 Screening09
Mh Page number 9 Screening
MH1
Diagnosis/Procedure
Diagnosis/Procedure
Ongoing
Ongoing
Sequence Number
Sequence Number
Diagnosis/Procedure
Date of Onset
Date of Onset
Date ofResolution
Date ofResolution
Diagnosis/Procedure
Diagnosis/Procedure
Ongoing
Ongoing
2
2
2
2
2
2
5
6
6
6
6
6
6
6
6
LEFT HIP REPLACEMENT
2
OVARIAN CYST
00-00-1997
00-00-1998
HOT FLASHES
<Row Deleted>
POST MENOPAUSAL
<Row Deleted>
CHECKED
<Row Deleted>
2
OVARIAN CYST (RIGHTOVARY)
<Row Deleted>
00-00-2007
<Row Deleted>
<Row Deleted>
RECURRENT JOINT PAIN
<Row Deleted>
CHECKED
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
11-MAR-2010 14:42:47
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Stephanie Felton
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 06-MAR-2013 16:13:44 88Page
R259447413
Page_09
CD_001
R5020 Screening09
Mh Page number 9 Screening
MH1
Sequence Number
Sequence Number
Date of Onset
Date of Onset
Date of Onset
Date of Onset
Date of Onset
Date ofResolution
Date ofResolution
Date ofResolution
Date ofResolution
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
6
6
7
7
7
7
7
7
7
7
7
7
7
7
7
6
00-00-2007
00-APR-2008
OSTEOARTHRITIS
ALLERGIES
<Row Deleted>
6
<Row Deleted>
<Row Deleted>
00-APR-2008
01-APR-2008
<Row Deleted>
<Row Deleted>
<Row Deleted>
ALLERGIES
<Row Deleted>
BACK SPASMS
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-JAN-2010 16:08:08
11-FEB-2010 12:56:24
11-FEB-2010 12:56:24
03-MAR-2010 12:44:09
04-DEC-2009 13:36:13
04-JAN-2010 16:08:08
11-FEB-2010 12:56:24
11-FEB-2010 12:56:24
04-DEC-2009 13:36:13
04-JAN-2010 16:08:08
11-FEB-2010 12:56:24
11-FEB-2010 12:56:24
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 06-MAR-2013 16:13:44 89Page
R259447413
Page_09
CD_001
R5020 Screening09
Mh Page number 9 Screening
MH1
Diagnosis/Procedure
Ongoing
Ongoing
Ongoing
Ongoing
Sequence Number
Sequence Number
Sequence Number
Sequence Number
Date of Onset
Date of Onset
Date of Onset
Date of Onset
Date of Onset
Date of Onset
Date of Onset
7
7
7
7
7
7
7
7
7
8
8
8
8
8
8
8
BACK SPASMS
CHECKED
CHECKED
7
7
00-00-2006
00-00-1996
00-00-1999
00-00-1985
INTERMITTENT BACK SPASMS
<Row Deleted>
CHECKED
<Row Deleted>
CHECKED
<Row Deleted>
7
<Row Deleted>
7
<Row Deleted>
00-00-1996
<Row Deleted>
00-00-1999
<Row Deleted>
00-00-1985
<Row Deleted>
08-MAR-2010 11:22:15
04-DEC-2009 13:36:13
04-JAN-2010 16:08:08
11-FEB-2010 12:56:24
11-FEB-2010 12:56:24
04-DEC-2009 13:36:13
04-JAN-2010 16:08:08
11-FEB-2010 12:56:24
11-FEB-2010 12:56:24
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
04-DEC-2009 13:36:13
03-MAR-2010 12:40:42
09-MAR-2010 11:08:22
27-APR-2010 12:39:56
01-JUN-2010 14:39:05
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 06-MAR-2013 16:13:44 90Page
R259447413
Page_09
CD_001
R5020 Screening09
Mh Page number 9 Screening
MH1
Date ofResolution
Date ofResolution
Date ofResolution
Date ofResolution
Date ofResolution
Date ofResolution
Date ofResolution
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
8
8
8
8
8
8
8
8
8
8
8
8
8
00-00-2006
BROKEN RIGHT TIBIA
POST MENOPAUSAL
INSOMNIA
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
POST MENOPAUSAL
<Row Deleted>
INSOMNIA
<Row Deleted>
SEASONAL ALLERGIES
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
04-DEC-2009 13:36:13
03-MAR-2010 12:40:42
09-MAR-2010 11:08:22
27-APR-2010 12:39:56
01-JUN-2010 14:39:05
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
04-DEC-2009 13:36:13
03-MAR-2010 12:40:42
09-MAR-2010 11:08:22
27-APR-2010 12:39:56
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 06-MAR-2013 16:13:44 91Page
R259447413
Page_09
CD_001
R5020 Screening09
Mh Page number 9 Screening
MH1
Diagnosis/Procedure
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Sequence Number
Sequence Number
Sequence Number
Sequence Number
Sequence Number
Sequence Number
Sequence Number
Date of Onset
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
9
SEASONAL ALLERGIES
CHECKED
CHECKED
CHECKED
8
8
8
8
00-00-2007
<Row Deleted>
<Row Deleted>
CHECKED
<Row Deleted>
CHECKED
<Row Deleted>
CHECKED
<Row Deleted>
<Row Deleted>
8
<Row Deleted>
8
<Row Deleted>
8
<Row Deleted>
<Row Deleted>
01-JUN-2010 14:39:05
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
04-DEC-2009 13:36:13
03-MAR-2010 12:40:42
09-MAR-2010 11:08:22
27-APR-2010 12:39:56
01-JUN-2010 14:39:05
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
04-DEC-2009 13:36:13
03-MAR-2010 12:40:42
09-MAR-2010 11:08:22
27-APR-2010 12:39:56
01-JUN-2010 14:39:05
04-DEC-2009 13:36:13
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 06-MAR-2013 16:13:44 92Page
R259447413
Page_09
CD_001
R5020 Screening09
Mh Page number 9 Screening
MH1
Date ofResolution
Diagnosis/Procedure
Ongoing
Sequence Number
Date of Onset
Date ofResolution
Diagnosis/Procedure
Ongoing
Sequence Number
9
9
9
9
10
10
10
10
10
RECURRENT JOINT PAIN
CHECKED
9
00-00-1996
POST MENOPAUSAL
CHECKED
10
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
<Row Deleted>
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
04-DEC-2009 13:36:13
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
22-OCT-2009 14:52:00
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 06-MAR-2013 16:13:44 93Page
R259448313
Page_10
CD_001
R5020 Screening10
Smoking History Page number 10 Screening
DRUGSCR
Attempted toquit (Otherattempts) (5)
Attempted toquit(Pharmaceuticals) (3)
Comments (otherattemps) (7)
Comments(pharmaceuticals) (5)
If Yes, how many(pharmaceuticals) (4)
If yes, how many(other attemptsto quit (6)
1
1
1
1
1
1
YES
NO
AFTER HOSPITAL STAY
1
NO
YES
ATTEMPTED TWICE USINGWELLBUTRIN
2
10-NOV-2009 13:28:10
10-NOV-2009 13:28:10
10-NOV-2009 13:28:10
10-NOV-2009 13:28:10
10-NOV-2009 13:28:10
10-NOV-2009 13:28:10
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 94Page
R259449713
Page_14
CD_001
R5020 Baseline, Week 014
Behavioral Coun Page number 14 Baseline, Week 0
EX1
Result
1 YES
23-JUL-2009 18:29:49
Sharon Ladenes
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 95Page
R265106013
Page_16
CD_001
R5020 Sptp, Weeks 1-416
Status Review Page number 16 Sptp, Weeks 1-4
CHKYN
Comments(contacted byphone) (1)
Comments(contacted byphone) (1)
Date
1
1
1
MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL.NO RETURN CALL RECEIVED
27-JUL-2009
MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL.NO RETURN CALL RECEIVED
ND
06-MAY-2010 13:01:26
06-MAY-2010 13:40:34
06-MAY-2010 13:01:26
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 96Page
R265106013
Page_16
CD_001
R5020 Sptp, Weeks 1-416
Status Review Page number 16.1 Sptp, Weeks 1-4
CHKYN
Comments(contacted byphone) (1)
Comments(contacted byphone) (1)
Date
1
1
1
MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL.NO RETURN CALL RECEIVED
03-AUG-2009
MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL.NO RETURN CALL RECEIVED
ND
06-MAY-2010 13:01:26
06-MAY-2010 13:40:34
06-MAY-2010 13:01:26
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 97Page
R265106013
Page_16
CD_001
R5020 Sptp, Weeks 1-416
Status Review Page number 16A Sptp, Weeks 1-4
CHKYN
Comments(contacted byphone) (1)
Comments(contacted byphone) (1)
Date
1
1
1
MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL.NO RETURN CALL RECEIVED
10-AUG-2009
MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL.NO RETURN CALL RECEIVED
ND
06-MAY-2010 13:01:26
06-MAY-2010 13:41:25
06-MAY-2010 13:01:26
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 98Page
R267031313
Page_17
CD_001
R5020 Ip, Week 617
Vs Page number 17 Ip, Week 6
VS
Diastolic BloodPressure
Systolic BloodPressure
1
1
90
123
UNK
UNK
10-FEB-2010 19:21:51
10-FEB-2010 19:21:51
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 99Page
R267031713
Page_18
CD_001
R5020 Ip, Week 618
Lb Page number 18 Ip, Week 6
LB
RequisitionNumber 1: (1)
Were there anyclinicallysignificant la(1)
1
1
NA
NO
20-OCT-2009 13:39:42
20-OCT-2009 13:39:42
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 100Page
R267032313
Page_20
CD_001
R5020 Ip, Week 620
Status Review Page number 20 Ip, Week 6
CHKYN
Comments(smoking statusreviewed) (2)1
SUBJECT STATES STILLSMOKING MOSTLY OUT OFHABIT. NOT SURE PRODUCTIS HELPING AS IT IS"AWAKWARD THAT IT'S INMY MOUTH"
22-OCT-2009 14:56:44
Sharon Ladenes
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 101Page
R275376013
Page_21
CD_001
R5020 Ip, Week 821
CRF Header
DCI Blank Flag
1
Y
N
10-FEB-2010 19:22:56
Sharon Ladenes
Data Entry Error
0
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 102Page
R275376013
Page_21
CD_001
R5020 Ip, Week 821
Status Review Page number 21 Ip, Week 8
CHKYN
Comments(contacted byphone) (1)
Comments(contacted byphone) (1)
Date
1
1
1
UNABLE TO CONTACT AFTER3 ATTEMPTS
14-SEP-2009
UNABLE TO CONTACT AFTER3 ATTEMPTS
ND
06-MAY-2010 13:08:16
06-MAY-2010 13:45:28
06-MAY-2010 13:08:16
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 103Page
R282982513
Page_27
CD_001
R5020 Ip, Week 1627
Lb Page number 27 Ip, Week 16
LB
Were there anyclinicallysignificant la(1)1
NO
10-FEB-2010 17:47:18
Sharon Ladenes
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 104Page
R291331313
Page_36
CD_001
R5020 Fu, Week 2836
CRF Header
DCI Blank Flag
1
Y
N
02-FEB-2010 12:53:14
Sharon Ladenes
Data Entry Error
0
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 105Page
R259450213
Page_39
CD_001
R5020 Pcm39
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
N
Y
Y
N
30-JUL-2009 16:38:07
03-SEP-2009 14:38:54
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
0
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 106Page
R259450213
Page_39
CD_001
R5020 Pcm39
Pcm Page number 39 Pcm
CM1
Dose
Dose
Dose
Drug name
Drug name
Drug name
Frequency
Frequency
Frequency
Has the subjecttaken anymedications pr
Has the subjecttaken anymedications pr
Indication
Indication
Indication
1
1
1
1
1
1
1
1
1
1
1
1
1
1
600
UNKNOWN
IBUPROFEN
MIDOL
EVERY DAY
ONCE
NO
PAIN
MENSTRAL CRAMPS
UNKNOWN
600
2
MIDOL
IBUPROFEN
OMEGA 1+
ONCE
EVERY DAY
EVERY DAY
NO
YES
MENSTRAL CRAMPS
PAIN
SUPPLEMENT
23-JUL-2009 18:39:49
23-JUL-2009 18:54:57
04-JAN-2010 16:42:28
23-JUL-2009 18:39:49
23-JUL-2009 18:54:57
04-JAN-2010 16:42:28
23-JUL-2009 18:39:49
23-JUL-2009 18:54:57
04-JAN-2010 16:42:28
03-SEP-2009 14:38:54
04-JAN-2010 16:05:18
23-JUL-2009 18:39:49
23-JUL-2009 18:54:57
04-JAN-2010 16:42:28
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
Row Inserted
CRA Correction
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Row Inserted
Data Entry Error
Data Entry Error
Data Entry Error
Row Inserted
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 107Page
R259450213
Page_39
CD_001
R5020 Pcm39
Pcm Page number 39 Pcm
CM1
Ongoing
Start Date
Start Date
Start Date
Start Date
Stop Date
Stop Date
Stop Date
Unit
Unit
Unit
other, specify(frequency)
other, specify(unit)
1
1
1
1
1
1
1
1
1
1
1
1
1
00-00-1995
00-00-1999
07-JUL-2009
13-JUL-2009
07-JUL-2009
MILLIGRAMS
CHECKED
00-00-1999
07-JUL-2009
00-00-1999
00-00-2008
07-JUL-2009
13-JUL-2009
MILLIGRAMS
TABLET
04-JAN-2010 16:42:28
23-JUL-2009 18:35:11
23-JUL-2009 18:39:49
23-JUL-2009 18:54:57
04-JAN-2010 16:42:28
23-JUL-2009 18:39:49
23-JUL-2009 18:54:57
04-JAN-2010 16:42:28
23-JUL-2009 18:39:49
23-JUL-2009 18:54:57
04-JAN-2010 16:42:28
04-JAN-2010 16:42:28
04-JAN-2010 16:42:28
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Row Inserted
Data Entry Error
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Row Inserted
Row Inserted
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 06-MAR-2013 16:13:44 108Page
R259450313
Page_39
CD_001
R5020 Pcm.1
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
N
Y
Y
N
30-JUL-2009 16:38:27
04-JAN-2010 16:43:31
Sharon Ladenes
Sharon Ladenes
Data Entry Error
CRA Correction
0
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 109Page
R259450313
Page_39
CD_001
R5020 Pcm.1
Pcm Page number 39 Pcm.1
CM1
Dose
Drug name
Frequency
Has the subjecttaken anymedications pr
Indication
Ongoing
Start Date
Stop Date
Unit
other, specify(frequency)
other, specify(unit)
1
1
1
1
1
1
1
1
1
1
1
1
MULTIVITAMIN
EVERY DAY
YES
SUPPLEMENT
CHECKED
00-00-1999
TABLET
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
04-JAN-2010 16:43:31
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 110Page
R286407313
Page_39
CD_001
R5020 Pcm.3
Pcm Page number 39 Pcm.3
CM1
Unit
other, specify(unit)
1
1
MILLIGRAMS
OTHER
INTERNATIONAL UNITS
10-FEB-2010 19:29:58
10-FEB-2010 19:29:58
Sharon Ladenes
Sharon Ladenes
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 111Page
R286407413
Page_39
CD_001
R5020 Pcm.4
Pcm Page number 39 Pcm.4
CM1
Dose
1
150
300
10-FEB-2010 18:03:30
Sharon Ladenes
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 112Page
R286407613
Page_39
CD_001
R5020 Pcm.5
Pcm Page number 39 Pcm.5
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
Dose
1
1
1
1
1
1
1
1
1
C
CARDIOVASCULAR SYSTEM, C
C01
CARDIAC THERAPY, C01
C01E
OTHER CARDIACPREPARATIONS, C01E
C01EB
OTHER CARDIACPREPARATIONS, C01EB
200
M
MUSCULO-SKELETAL SYSTEM,M
M01
ANTIINFLAMMATORY ANDANTIRHEUMATIC PRODUCTS,M01
M01A
ANTIINFLAMMATORY/ANTIRHEUMATIC PROD.,NON-STEROIDS, M01A
M01AE
PROPIONIC ACIDDERIVATIVES, M01AE
600
27-APR-2010 12:10:38
27-APR-2010 12:10:38
27-APR-2010 12:10:38
27-APR-2010 12:10:38
27-APR-2010 12:10:38
27-APR-2010 12:10:38
27-APR-2010 12:10:38
27-APR-2010 12:10:38
10-FEB-2010 18:04:37
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Sharon Ladenes
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 113Page
R286407813
Page_39
CD_001
R5020 Pcm.6
Pcm Page number 39 Pcm.6
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
Dose
Drug name
Indication
Indication
Indication
Preferred Term
Preferred TermCode
1
1
1
1
1
1
1
1
1
1
1
1
1
25
ALLERGY ANAHISTINE
SLEEPING
SLEEP AID
SLEEP AID IN RELATION TOSEASONAL ALLERGIES
R
RESPIRATORY SYSTEM, R
R06
ANTIHISTAMINES FORSYSTEMIC USE, R06
R06A
ANTIHISTAMINES FORSYSTEMIC USE, R06A
50
ALLERGY ANTIHISTAMINE
SLEEP AID
SLEEP AID IN RELATION TOSEASONAL ALLERGIES
SLEEP AID
ANTIHISTAMINES
90047901001
26-APR-2010 10:36:00
26-APR-2010 10:36:00
26-APR-2010 10:36:00
26-APR-2010 10:36:00
26-APR-2010 10:36:00
26-APR-2010 10:36:00
10-FEB-2010 19:31:02
08-MAR-2010 16:21:05
11-FEB-2010 13:01:33
27-APR-2010 11:56:14
01-JUN-2010 14:40:31
26-APR-2010 10:36:00
26-APR-2010 10:36:00
Carol Kraucyk
Carol Kraucyk
Carol Kraucyk
Carol Kraucyk
Carol Kraucyk
Carol Kraucyk
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Carol Kraucyk
Carol Kraucyk
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Class. Change
Class. Change
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 114Page
R286408013
Page_39
CD_001
R5020 Pcm.7
Pcm Page number 39 Pcm.7
CM1
Indication
Ongoing
Stop Date
Stop Date
Stop Date
1
1
1
1
1
BACK SPASMS
CHECKED
UNK
30-SEP-2009
PRE-EXISTING BACK SPASMSINTERMITTENT
UNK
30-SEP-2009
11-SEP-2009
04-MAR-2010 14:39:39
04-FEB-2010 17:59:26
04-FEB-2010 17:59:26
04-MAR-2010 14:39:39
08-MAR-2010 11:25:03
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
SUBJECT REPORTSEXACT DAY UNKNOWN,HOWEVER IT WASONLY A 30 DAYSUPPLY
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
Data Entry Error
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 115Page
R272840913
Page_40
CD_001
R5020 Ae40
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
N
Y
Y
N
10-NOV-2009 18:50:44
02-FEB-2010 14:07:14
Sharon Ladenes
Sharon Ladenes
Key Change
Data Entry Error
0
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 116Page
R282982213
Page_43
CD_001
R5020 Additional Vs43
Vs Page number 43 Additional Vs
VS
Body Temperature
Heart Rate
Respiratory Rate
1
1
1
NA
NA
NA
ND
ND
ND
25-FEB-2010 12:12:32
25-FEB-2010 12:12:32
25-FEB-2010 12:12:32
Sharon Ladenes
Sharon Ladenes
Sharon Ladenes
Validation Statuschanged
Validation Statuschanged
Validation Statuschanged
1
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 06-MAR-2013 16:13:44 117Page
R259337813
CD_001
CD_001
R5020
R5020
1789641613
20543911
SCREENING
SCREENING
IC
IC
2
2
PAGE_02
PAGE_02
Inclusion Criteria Answer 6
CURRENT
CURRENT
Data value changed. Disc no longer applicable.
Confirmed
MANUAL
MULTIVARIATE
Resolved-Response Edited
Resolved-Response Edited
NO
Waiver granted for subject not having regular dental check-ups. Please revise responseto question.
Response to Inclusion Criterion <06> is No. Please verify response and ensure subjecteligibility page is completed as appropriate.
Discrepancy Detail ReportDocument #:
Discrepancy ID:
Discrepancy ID:
Visit:
Visit:
CRF:
CRF:
Field:
Field:
Value Text:
Value Text:
Type:
Type:
Review Status:
Review Status:
Discrepancy:
Discrepancy:
Internal Comment:
Internal Comment:
Resolution Type:
Resolution Type:
Resolution Text:
Resolution Text:
Status:
Status:
Site:
Site:
Visit Date:
Visit Date:
Section:
Section:
Patient:
Patient:
Qualifying Value:
Qualifying Value:
Row:
Row:
Report run by Brian Saari at 06-MAR-2013 16:13:44 118Page
R259352813
CD_001 R50201789641713
SCREENING
EC 3PAGE_03
Exclusion Criteria Answer 3
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
NO
Please verify if this questions should be answered No see query for inclusion #6.
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
Type:
Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
Site:
Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 16:13:44 119Page
R259445213
CD_001 R50201789641813
SCREENING
ELIG 4PAGE_04
Category 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
I
Please verify if this should be 'I' number 6.
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
Type:
Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
Site:
Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 16:13:44 120Page
R259447413
CD_001 R502081724111
SCREENING
MH 9PAGE_09
Diagnosis/Procedure 5
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
OVARIAN CYST (RIGHT OVARY)
Per source this is the right ovary. Please review source and amend CRF page ifapplicable.
Updated CRF, verified source
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
Type:
Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
Site:
Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 16:13:44 121Page
R265106013
CD_001 R5020115220811
SPTP, WEEKS 1-4
STATUS REVIEW 16PAGE_16
Date 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
ND
Please update date to 'ND' as assessment did not occur.
DM Response: Please replace the comment that was previously present (MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED).
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
Type:
Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
Site:
Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 16:13:44 122Page
R265106013
CD_001 R5020115220911
SPTP, WEEKS 1-4
STATUS REVIEW 16.1PAGE_16
Date 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
ND
Please update date to 'ND' as assessment did not occur.
DM Response: Please replace the comment that was previously present (MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED).
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
Type:
Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
Site:
Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 16:13:44 123Page
R265106013
CD_001 R5020115221011
SPTP, WEEKS 1-4
STATUS REVIEW 16APAGE_16
Date 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
ND
Please update date to 'ND' as assessment did not occur.
DM Response: Please replace the comment that was previously present (MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED).
Document #:
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Report run by Brian Saari at 06-MAR-2013 16:13:44 124Page
R267031313
CD_001 R502060985311
IP, WEEK 6
VS 17PAGE_17
Systolic Blood Pressure 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
UNK
Please review footnotes regarding the systolic /diastolic at this visit. Amend CRF pageif applicable.
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Report run by Brian Saari at 06-MAR-2013 16:13:44 125Page
R275376013
CD_001
CD_001
R5020
R5020
115222211
60986211
IP, WEEK 8
IP, WEEK 8
STATUS REVIEW
STATUS REVIEW
21
21
PAGE_21
PAGE_21
Date 1
CURRENT
CURRENT
Data value changed. Disc no longer applicable.
Data value changed. Disc no longer applicable.
MANUAL
MANUAL HEADER
Resolved-Response Edited
Resolved-Response Edited
ND
Please update date to 'ND' as assessment did not occur.
Please review source. Please add the date of the visit, check no to the first questionand enter comment from source unable to contact subject after 3 attempts.
DM Response: A comment was previously present 'Unable to contact after 3 attempts'.Please replace comment.
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Report run by Brian Saari at 06-MAR-2013 16:13:44 126Page
R282982513
CD_001 R502061027711
IP, WEEK 16
LB 27PAGE_27
Were there any clinically significant la 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
NO
Please answer question.
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Report run by Brian Saari at 06-MAR-2013 16:13:44 127Page
R286407313
CD_001 R502061028411
PCM.3
PCM 39PAGE_39
Unit 1
CURRENT
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Resolved-Response Edited
OTHER
Please clarify the units, source shows international units. Please review source,clarify and amend CRF page if applicable.
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Report run by Brian Saari at 06-MAR-2013 16:13:44 128Page
R286407413
CD_001 R502061028611
PCM.4
PCM 39PAGE_39
Dose 1
CURRENT
Data value changed. Disc no longer applicable.
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Resolved-Response Edited
300
Please see source for correct amount. Per source, 150 mg capsules that the subject takes2 capsules (300mg) everyday. Please review and amend CRF page if applicable.
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Report run by Brian Saari at 06-MAR-2013 16:13:44 129Page
R286407613
CD_001 R502061028711
PCM.5
PCM 39PAGE_39
Dose 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
600
Please review source for amount taken, 200 mg soft gels which the subject takes 3 softgels QD. Please review and amend CRF if applicable.
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Report run by Brian Saari at 06-MAR-2013 16:13:44 130Page
R286407813
CD_001
CD_001
CD_001
R5020
R5020
R5020
61029011
79784811
60899211
PCM.6
PCM.6
PCM.6
PCM
PCM
PCM
39
39
39
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PAGE_39
Dose
Drug name
Indication
1
1
1
CURRENT
CURRENT
CURRENT
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Data value changed. Disc no longer applicable.
Data value changed. Disc no longer applicable.
MANUAL
MANUAL
MANUAL
Resolved-Response Edited
Resolved-Response Edited
Resolved-Response Edited
50
ALLERGY ANTIHISTAMINE
SLEEP AID
Please review amount taken by subject.
Please verify spelling of antihistamine.
Per monitor, please amend indication to sleep aid.
confirmed
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Report run by Brian Saari at 06-MAR-2013 16:13:44 131Page
R286407813
CD_001
CD_001
R5020
R5020
98559511
104319811
PCM.6
PCM.6
PCM
PCM
39
39
PAGE_39
PAGE_39
CURRENT
CURRENT
Confirmed
Confirmed
MANUAL HEADER
MANUAL HEADER
Resolved-Response Edited
Resolved-Response Edited
Please verify indication of sleep aid. If correct, please provide reason andcorresponding medical history.
Please update indication to indicate that it is a sleep aid in relation to seasonalallergies.
Seasonal allergies prevent subject from sleeping
Please also add Seasonal allergies to Medical history. - PLEASE ADD DONE
Verified. JLM 20Apr2010
Verified. JLM 27Apr2010
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Report run by Brian Saari at 06-MAR-2013 16:13:44 132Page
Deleted CRFs Report