CRF Report for Study E7694105 · CRF Report for Study E7694105 Report run by Brian Saari at...
114
CRF Report for Study E7694105 Report run by Brian Saari at 06-MAR-2013 13:08:04 Abc 123 Abc 123 CDB_001 All statuses All statuses R1025 R1025 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: Prompt Data value Data value with discrepancy
Transcript of CRF Report for Study E7694105 · CRF Report for Study E7694105 Report run by Brian Saari at...
CRF Report for Study E7694105Report run by Brian Saari at 06-MAR-2013 13:08:04
Abc 123
Abc 123
CDB_001
All statuses
All statuses
R1025
R1025
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
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
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16.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history 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
20.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
21.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
30.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
31.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
32.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
33.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
37.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
38.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.LINKS
Links to Discrepancy and Audit Sections
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39.1.U1.LINKS
Links to Discrepancy and Audit Sections
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Click here to navigate to discrepancy details for this CRF
39.1.U2.LINKS
Links to Discrepancy and Audit Sections
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40.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
40.U1.LINKS
Links to Discrepancy and Audit Sections
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44.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Appendix: Audit and Discrepancy Information
Report run by Brian Saari at 06-MAR-2013 13:08:08 70Page
Report run by Brian Saari at 06-MAR-2013 13:08:08 71Page
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 13:08:08 72Page
R255355513
Page_09
CDB_001
R1025 Screening09
Mh Page number 9 Screening
MH1
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
Date of Onset
Date of Onset
Date ofResolution
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
Ongoing
Ongoing
Sequence Number
3
4
4
6
6
6
6
6
6
6
6
6
HYSTORECTOMY
WELLBUTIN ALLERGIES
WELLBRUTIN ALLERGIES
LEG CRAMPS
HYSTERECTOMY
WELLBRUTIN ALLERGIES
WELLBUTRIN ALLERGIES
00-00-1995
LEG CRAMPS
LEG CRAMPS-OCCASIONALLYAT NIGHT
CHECKED
03-DEC-2009 09:19:41
26-JUN-2009 14:12:07
26-APR-2010 14:10:47
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
01-MAR-2010 11:04:13
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
Sharon Daly
Rossana Matos
Joanne Mccaigue
Heather Kretschmer
Sharon Daly
Heather Kretschmer
Heather Kretschmer
Sharon Daly
Christina Breedlove
Heather Kretschmer
Sharon Daly
Heather Kretschmer
Obvious spellingcorrection. JLM26Apr2010
confirmed persource, "legcramps occur"occasionally atnight"
Data Entry Error
Data Entry Error
ODM/SEC
Row Inserted
Data Entry Error
Row Inserted
Row Inserted
Data Entry Error
Data Entry Mode
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 13:08:08 73Page
R255355513
Page_09
CDB_001
R1025 Screening09
Mh Page number 9 Screening
MH1
Sequence Number
Date of Onset
Date of Onset
Date ofResolution
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
Ongoing
Ongoing
Sequence Number
Sequence Number
Sequence Number
Date of Onset
Date of Onset
Date ofResolution
6
7
7
7
7
7
7
7
7
7
7
7
8
8
8
OSTROPENIA
6
6
00-00-2008
OSTROPENIA
OSTEOPENIA
CHECKED
6
7
00-00-2002
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
03-DEC-2009 09:16:31
10-NOV-2009 16:08:56
10-NOV-2009 16:08:56
03-DEC-2009 09:16:31
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
03-DEC-2009 09:16:31
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
Sharon Daly
Heather Kretschmer
Sharon Daly
Heather Kretschmer
Heather Kretschmer
Sharon Daly
Sharon Daly
Heather Kretschmer
Sharon Daly
Heather Kretschmer
Sharon Daly
Sharon Daly
Heather Kretschmer
Sharon Daly
Heather Kretschmer
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Row Inserted
Data Entry Error
Data Entry Error
Row Inserted
Data Entry Error
Row Inserted
Data Entry Error
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 13:08:08 74Page
R255355513
Page_09
CDB_001
R1025 Screening09
Mh Page number 9 Screening
MH1
Diagnosis/Procedure
Diagnosis/Procedure
Ongoing
Ongoing
Sequence Number
Sequence Number
8
8
8
8
8
8
SCOLIOSIS
CHECKED
8
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
10-NOV-2009 16:08:56
03-DEC-2009 09:19:41
Heather Kretschmer
Sharon Daly
Heather Kretschmer
Sharon Daly
Heather Kretschmer
Sharon Daly
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 13:08:08 75Page
R255360713
Page_10
CDB_001
R1025 Screening10
Smoking History Page number 10 Screening
DRUGSCR
Comments(pharmaceuticals) (5)1
CHANTIX(2X),WELLBRUTIN(1X)CHANTIX(2X),WELLBUTRIN(1X)
24-MAR-2010 14:54:32
Krysia Magnuson wellbrutin towellbutrin. KAY24Mar2010.
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 13:08:08 76Page
R256687213
Page_16
CDB_001
R1025 Sptp, Weeks 1-416
Status Review Page number 16A Sptp, Weeks 1-4
Section Header
DCM Blank flag
DCM Blank flag
1
1
N
Y
Y
N
10-JUL-2009 12:36:48
16-JUL-2009 14:25:42
Rossana Matos
Rossana Matos
Key Change
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 13:08:08 77Page
R256687213
Page_16
CDB_001
R1025 Sptp, Weeks 1-416
Status Review Page number 16B Sptp, Weeks 1-4
Section Header
DCM Blank flag
DCM Blank flag
1
1
N
Y
Y
N
10-JUL-2009 12:36:48
23-JUL-2009 13:57:47
Rossana Matos
Sharon Daly week 4 informationwas just receivedtoday and needs tobe entered
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 13:08:08 78Page
R265927613
Page_17
CDB_001
R1025 Ip, Week 617
Vs Page number 17 Ip, Week 6
VS
Weight
1
147
147.0
03-JUN-2010 10:42:05
Christina Breedlove entered decimal
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 13:08:08 79Page
R265928213
Page_20
CDB_001
R1025 Ip, Week 620
Status Review Page number 20 Ip, Week 6
CHKYN
Was Subjectasked HDYF? (8)
Was Subjectasked HDYF? (8)
1
1
YES
NO
NO
YES
03-DEC-2009 09:25:59
03-DEC-2009 09:31:26
Sharon Daly
Sharon Daly
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 13:08:08 80Page
R265928213
Page_20
CDB_001
R1025 Ip, Week 620
Diary Page number 20 Ip, Week 6
Section Header
DCM Blank flag
1
Y
N
22-JAN-2010 12:34:41
Christina Breedlove
Validation Statuschanged
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 13:08:08 81Page
R257572013
Page_21
CDB_001
R1025 Ip, Week 821
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
N
Y
Y
N
10-JUL-2009 12:30:57
10-JUL-2009 12:31:18
Rossana Matos
Rossana Matos
Key Change
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 13:08:08 82Page
R257572013
Page_21
CDB_001
R1025 Ip, Week 821
Status Review Page number 21 Ip, Week 8
CHKYN
Comments (HDYF)(8)
Comments(behavioralcounseling) (6)
Comments(compliant) (4)
Comments(contacted byphone) (1)
Comments (howmany cigarettes)(5)
Comments(smoking statusreviewed) (2)
Comments (studyproductreviewed) (3)
Date
If Subject wasnot compliant,approximat (5)
Was BehavioralCounseling Given(6)
Was Subjectasked HDYF? (8)
1
1
1
1
1
1
1
1
1
1
1
20-AUG-2009
YES
YES
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
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 13:08:08 83Page
R257572013
Page_21
CDB_001
R1025 Ip, Week 821
Status Review Page number 21 Ip, Week 8
CHKYN
Was Subjectcompliant (4)
Was Subjectcontacted bytelephone (1)
Was Subject'ssmoking statusreviewed (2)
Was Subject'suse of studyproduct revie(3)
1
1
1
1
YES
YES
YES
YES
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
27-AUG-2009 13:32:19
Sharon Daly
Sharon Daly
Sharon Daly
Sharon Daly
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
Report run by Brian Saari at 06-MAR-2013 13:08:08 84Page
R274531513
Page_30
CDB_001
R1025 Ip, Week 1630
Eco Page number 30 Ip, Week 16
EX1
Actual Time
1
0103
1031
03-DEC-2009 09:35:06
Sharon Daly
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 13:08:08 85Page
R274532113
Page_31
CDB_001
R1025 Ip, Week 1631
Status Review Page number 31 Ip, Week 16
CHKYN
If Subject wasnot compliant,approximat (5)
Was Subjectcompliant (4)
1
1
0
NO
YES
07-JAN-2010 09:39:49
03-DEC-2009 09:37:28
Sharon Daly
Sharon Daly
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 13:08:08 86Page
R282882013
Page_32
CDB_001
R1025 Fu, Week 20 & 2432
Status Review Page number 32.1 Fu, Week 20 & 24
CHKYN
If Subject wasnot compliant,approximat (5)1
0 31-DEC-2009 12:04:29
Sharon Daly
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 13:08:08 87Page
R287082413
Page_33
CDB_001
R1025 Fu, Week 2833
Vs Page number 33 Fu, Week 28
VS
Actual Time
Body Temperature
Diastolic BloodPressure
Heart Rate
Systolic BloodPressure
Weight
1
1
1
1
1
1
1314
36.8
077
070
106
158.6
1026
36.4
080
060
119
153.6
10-FEB-2010 17:43:48
10-FEB-2010 17:43:48
10-FEB-2010 17:43:48
10-FEB-2010 17:43:48
10-FEB-2010 17:43:48
10-FEB-2010 17:43:48
Christina Breedlove
Christina Breedlove
Christina Breedlove
Christina Breedlove
Christina Breedlove
Christina Breedlove
confirmed withsource
confirmed withsource
confirmed withsource
confirmed withsource
confirmed withsource
confirmed withsource
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 13:08:08 88Page
R287082813
Page_37
CDB_001
R1025 Fu, Week 2837
Eco Page number 37 Fu, Week 28
EX1
%COHb
Actual Time
Actual Time
ECO Level
1
1
1
1
158.6
1318
1328
208
0.0
1328
1028
0
09-JAN-2010 11:47:54
09-JAN-2010 11:47:54
10-FEB-2010 17:47:19
09-JAN-2010 11:47:54
Rossana Matos
Rossana Matos
Christina Breedlove
Rossana Matos
confirmed withsource
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 13:08:08 89Page
R287082913
Page_38
CDB_001
R1025 Fu, Week 2838
Status Review Page number 38 Fu, Week 28
CHKYN
If Subject wasnot compliant,approximat (5)
Was Subjectcompliant (4)
1
1
35
NO
YES
10-FEB-2010 17:48:34
10-FEB-2010 17:48:34
Christina Breedlove
Christina Breedlove
confirmed withsource
confirmed withsource
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 13:08:08 90Page
R257044213
Page_39
CDB_001
R1025 Pcm39
Pcm Page number 39 Pcm
CM1
Frequency
1 EVERY DAY
08-JUL-2009 10:22:32
Rossana Matos
InvestigatorCorrection
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 13:08:08 91Page
R257044513
Page_39
CDB_001
R1025 Pcm.1
Pcm Page number 39 Pcm.1
CM1
Dose
Dose
other, specify(unit)
other, specify(unit)
1
1
1
1
3MG/3ML
3/3
LIQ.
MG/ML
3/3
1
MG/ML
IV BOLUS INJECTION
13-APR-2010 13:28:29
20-APR-2010 13:48:34
13-APR-2010 13:28:29
20-APR-2010 13:48:34
Christina Breedlove
Christina Breedlove
Christina Breedlove
Christina Breedlove
per query
per query
per query
per query
InvestigatorCorrection
InvestigatorCorrection
InvestigatorCorrection
InvestigatorCorrection
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 13:08:08 92Page
R287083013
Page_39
CDB_001
R1025 Pcm.2
CRF Header
DCI Blank Flag
1
N
Y
08-FEB-2010 17:05:50
Christina BreedloveRemoved data.Entered in error.
Validation Statuschanged
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 13:08:08 93Page
R282872913
Page_40
CDB_001
R1025 Ae40
Ae Page number 40 Ae
AE1
Action Specify
Action Taken
1
1
PRODUCT REDUCED
OTHER TREATMENT
NONE
10-FEB-2010 17:50:13
10-FEB-2010 17:50:13
Christina Breedlove
Christina Breedlove
confirmed withsource
confirmed withsource
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 13:08:08 94Page
R290608613
Page_40
CDB_001
R1025 Ae.1
Ae Page number 40 Ae.1
AE1
Ongoing
Resolved Date
Resolved Time
Serious Event
1
1
1
1
20-JAN-2010
1525
YES
CHECKED
NO
20-APR-2010 13:53:15
20-APR-2010 13:53:15
20-APR-2010 13:53:15
01-MAR-2010 12:44:04
Christina Breedlove
Christina Breedlove
Christina Breedlove
Christina Breedlove Confirmed to be NO
InvestigatorCorrection
InvestigatorCorrection
InvestigatorCorrection
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 13:08:08 95Page
R292526313
Page_44
CDB_001
R1025 Additional Pe44
CRF Header
DCI Blank Flag
1
N
Y
08-FEB-2010 17:18:29
Christina Breedlove
Key Change
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 13:08:08 96Page
R292526313
Page_44
CDB_001
R1025 Additional Pe44
Pe Page number 44 Additional Pe
DTE
MH1
Date
Does the subjecthave anyabnormal findi
1
1
03-SEP-2009
NO
08-FEB-2010 17:17:53
08-FEB-2010 17:17:53
Christina Breedlove
Christina Breedlove
Removed data.Entered in error.
Removed data.Entered in error.
Data Entry Error
Data Entry Error
1
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group #
Group #
Group Name
Group Name
Field
Field
Row
Row
Changed From
Changed From
Changed To
Changed To
Impact onresequence
Impact onresequence
On
On
By
By
Reason
Reason
Comment
Comment
Report run by Brian Saari at 06-MAR-2013 13:08:08 97Page
R255355513
CDB_001
CDB_001
CDB_001
R1025
R1025
R1025
13757811
13756811
13758011
SCREENING
SCREENING
SCREENING
MH
MH
MH
9
9
9
PAGE_09
PAGE_09
PAGE_09
Date of Onset
Date of Onset
Date of Onset
6
7
8
CURRENT
CURRENT
CURRENT
Data value changed. Disc no longer applicable.
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
1995
2008
2002
Discrepancy Detail ReportDocument #:
Discrepancy ID:
Discrepancy ID:
Discrepancy ID:
Visit:
Visit:
Visit:
CRF:
CRF:
CRF:
Field:
Field:
Field:
Value Text:
Value Text:
Value Text:
Type:
Type:
Type:
Review Status:
Review Status:
Review Status:
Discrepancy:
Discrepancy:
Discrepancy:
Internal Comment:
Internal Comment:
Internal Comment:
Resolution Type:
Resolution Type:
Resolution Type:
Resolution Text:
Resolution Text:
Resolution Text:
Status:
Status:
Status:
Site:
Site:
Site:
Visit Date:
Visit Date:
Visit Date:
Section:
Section:
Section:
Patient:
Patient:
Patient:
Qualifying Value:
Qualifying Value:
Qualifying Value:
Row:
Row:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 98Page
R255355513
CDB_001
CDB_001
CDB_001
R1025
R1025
R1025
1789623313
1789623413
1789623513
SCREENING
SCREENING
SCREENING
MH
MH
MH
9
9
9
PAGE_09
PAGE_09
PAGE_09
Diagnosis/Procedure
Diagnosis/Procedure
Diagnosis/Procedure
6
7
8
CURRENT
CURRENT
CURRENT
Data value changed. Disc no longer applicable.
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
LEG CRAMPS-OCCASIONALLY AT NIGHT
OSTEOPENIA
SCOLIOSIS
Please update diagnosis/procedure term to clarify if this is an intermittent/episodiccondition or a continuous chronic condition.
Please verify per med hx source osteopenia shoud be added.
Please verify per med hx source scoliosis should be added.
confirmed per source, "leg cramps occur "occasionally at night"
verified, will add
will add
Discrepancy ID:
Discrepancy ID:
Discrepancy ID:
Visit:
Visit:
Visit:
CRF:
CRF:
CRF:
Field:
Field:
Field:
Value Text:
Value Text:
Value Text:
Type:
Type:
Type:
Review Status:
Review Status:
Review Status:
Discrepancy:
Discrepancy:
Discrepancy:
Internal Comment:
Internal Comment:
Internal Comment:
Resolution Type:
Resolution Type:
Resolution Type:
Resolution Text:
Resolution Text:
Resolution Text:
Status:
Status:
Status:
Site:
Site:
Site:
Visit Date:
Visit Date:
Visit Date:
Section:
Section:
Section:
Patient:
Patient:
Patient:
Qualifying Value:
Qualifying Value:
Qualifying Value:
Row:
Row:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 99Page
R255355513
CDB_001
CDB_001
CDB_001
CDB_001
R1025
R1025
R1025
R1025
1717721913
13758111
13757711
13756711
SCREENING
SCREENING
SCREENING
SCREENING
MH
MH
MH
MH
9
9
9
9
PAGE_09
PAGE_09
PAGE_09
PAGE_09
Does the subject have any relevant medic
Ongoing
Sequence Number
Sequence Number
1
8
6
7
CURRENT
CURRENT
CURRENT
CURRENT
Confirmed
Data value changed. Disc no longer applicable.
Data value changed. Disc no longer applicable.
Data value changed. Disc no longer applicable.
MANUAL
MANUAL
MANUAL
MANUAL
Resolved-Response Edited
Resolved-Response Edited
Resolved-Response Edited
Resolved-Response Edited
YES
CHECKED
6
7
Please have MD assign relevance, update CRF if necessary.
investigator finds relevant, but NCS
Discrepancy ID:
Discrepancy ID:
Discrepancy ID:
Discrepancy ID:
Visit:
Visit:
Visit:
Visit:
CRF:
CRF:
CRF:
CRF:
Field:
Field:
Field:
Field:
Value Text:
Value Text:
Value Text:
Value Text:
Type:
Type:
Type:
Type:
Review Status:
Review Status:
Review Status:
Review Status:
Discrepancy:
Discrepancy:
Discrepancy:
Discrepancy:
Internal Comment:
Internal Comment:
Internal Comment:
Internal Comment:
Resolution Type:
Resolution Type:
Resolution Type:
Resolution Type:
Resolution Text:
Resolution Text:
Resolution Text:
Resolution Text:
Status:
Status:
Status:
Status:
Site:
Site:
Site:
Site:
Visit Date:
Visit Date:
Visit Date:
Visit Date:
Section:
Section:
Section:
Section:
Patient:
Patient:
Patient:
Patient:
Qualifying Value:
Qualifying Value:
Qualifying Value:
Qualifying Value:
Row:
Row:
Row:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 100Page
R255355513
CDB_001 R102513757911
SCREENING
MH 9PAGE_09
Sequence Number 8
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
8
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 13:08:08 101Page
R265927613
CDB_001 R102590338411
IP, WEEK 6
VS 17PAGE_17
Weight 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
147.0
Please verify if weight should be 147.0 vs. 147.
entered decimal
Confirmed data was corrected.
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 13:08:08 102Page
R265928213
CDB_001
CDB_001
CDB_001
CDB_001
R1025
R1025
R1025
R1025
1789942913
13758611
13758711
13758811
IP, WEEK 6
IP, WEEK 6
IP, WEEK 6
IP, WEEK 6
DIARY
DIARY
DIARY
DIARY
20
20
20
20
PAGE_20
PAGE_20
PAGE_20
PAGE_20
CURRENT
CURRENT
CURRENT
CURRENT
Data value changed. Disc no longer applicable.
Data value changed. Disc no longer applicable.
Data value changed. Disc no longer applicable.
Confirmed
MANUAL HEADER
MANUAL HEADER
MANUAL HEADER
MANUAL HEADER
Resolved-Response Edited
Resolved-Response Edited
Resolved-Response Edited
Resolved-Response Edited
Please complete.
will complete
will not allow me to enter information, area still gray
Document #:
Discrepancy ID:
Discrepancy ID:
Discrepancy ID:
Discrepancy ID:
Visit:
Visit:
Visit:
Visit:
CRF:
CRF:
CRF:
CRF:
Field:
Field:
Field:
Field:
Value Text:
Value Text:
Value Text:
Value Text:
Type:
Type:
Type:
Type:
Review Status:
Review Status:
Review Status:
Review Status:
Discrepancy:
Discrepancy:
Discrepancy:
Discrepancy:
Internal Comment:
Internal Comment:
Internal Comment:
Internal Comment:
Resolution Type:
Resolution Type:
Resolution Type:
Resolution Type:
Resolution Text:
Resolution Text:
Resolution Text:
Resolution Text:
Status:
Status:
Status:
Status:
Site:
Site:
Site:
Site:
Visit Date:
Visit Date:
Visit Date:
Visit Date:
Section:
Section:
Section:
Section:
Patient:
Patient:
Patient:
Patient:
Qualifying Value:
Qualifying Value:
Qualifying Value:
Qualifying Value:
Row:
Row:
Row:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 103Page
R274531513
CDB_001 R10251789944713
IP, WEEK 16
ECO 30PAGE_30
Actual Time 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
1031
Please verify time per source.
should be 10:31, will change
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
Type:
Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
Site:
Visit Date:
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Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 104Page
R274532113
CDB_001 R10251789944813
IP, WEEK 16
STATUS REVIEW 31PAGE_31
Was Subject compliant 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
YES
Please verify per guidelines compliance question is regarding cigarettes smoked,therefore answer should be "yes". Please delete "0".
verified
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
Type:
Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
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Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 105Page
R282882013
CDB_001 R102533546211
FU, WEEK 20 & 2
STATUS REVIEW 32.1PAGE_32
If Subject was not compliant, approximat 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
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 13:08:08 106Page
R287082413
CDB_001 R102558665111
FU, WEEK 28
VS 33PAGE_33
Actual Time 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
1026
Please verify per source, all vital data, except date is incorrect.
confirmed with source
confirmed with 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 13:08:08 107Page
R287082813
CDB_001 R102558665311
FU, WEEK 28
ECO 37PAGE_37
Actual Time 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
1028
Please verify time.
confirmed with source
confirmed with 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 13:08:08 108Page
R287082913
CDB_001
CDB_001
R1025
R1025
58665611
58665511
FU, WEEK 28
FU, WEEK 28
STATUS REVIEW
STATUS REVIEW
38
38
PAGE_38
PAGE_38
If Subject was not compliant, approximat
Was Subject compliant
1
1
CURRENT
CURRENT
Confirmed
Confirmed
MANUAL
MANUAL
Resolved-Response Edited
Resolved-Response Edited
YES
Please verify should be blank.
Please verify per diary and check-in questionnaire, subject was compliant.
confirmed with source
confirmed with source
confirmed with source
confirmed with source
Document #:
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:
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Patient:
Patient:
Qualifying Value:
Qualifying Value:
Row:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 109Page
R257044513
CDB_001
CDB_001
R1025
R1025
98506011
102147911
PCM.1
PCM.1
PCM
PCM
39
39
PAGE_39
PAGE_39
Dose 1
CURRENT
CURRENT
Confirmed
Confirmed
MANUAL
MANUAL HEADER
Resolved-Response Edited
Resolved-Response Edited
1
Please verify updating dose to '3/3' and unit to 'mg/ml'
Combination drug doses/units should be captured # of units. For example, dose = 1 andunit = to cup.
per query
per query
Verified. JLM 19Apr2010
Verified. JLM 23Apr2010
Document #:
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 13:08:08 110Page
R282872913
CDB_001
CDB_001
R1025
R1025
58666211
20532711
AE
AE
AE
AE
40
40
PAGE_40
PAGE_40
Action Taken 1
CURRENT
CURRENT
Confirmed
Data value changed. Disc no longer applicable.
MANUAL
MULTIVARIATE
Resolved-Response Edited
Resolved-Response Edited
NONE
please verify per action with respect to subject "none" should be entered.
Resolved Date and Time <26-JUN-2009> at <0800> is prior to Onset Date and Time <26-JUN-2009> at <0800> for Adverse Event <LIGHT HEADEDNESS>. Please provide correct Onset andResolved dates and times.
resolution time and onset time are within the same minute; therefore are the same/ SD
Document #:
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 13:08:08 111Page
R290608613
CDB_001 R1025102251911
AE.1
AE 40PAGE_40
Outcome to Date 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
CONT WITHOUT TREATMENT
Resolved date and time is present. Please verify updating Outcome to Recovered.
Resolved date and time removed. AE was ongoing without treatment when subject completedthe study.
Verified. JLM 23Apr2010
Document #:
Discrepancy ID:
Visit:
CRF:
Field:
Value Text:
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Review Status:
Discrepancy:
Internal Comment:
Resolution Type:
Resolution Text:
Status:
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Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 06-MAR-2013 13:08:08 112Page
Deleted CRFs Report
