CRF Report for Study E7694105D ap… · CRF Report for Study E7694105D Report run by Brian Saari at...
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CRF Report for Study E7694105D Report run by Brian Saari at 21-FEB-2013 14:47:32 Abc 123 Abc 123 CD_001 All statuses All statuses R5003 R5003 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 E7694105D ap… · CRF Report for Study E7694105D Report run by Brian Saari at...
CRF Report for Study E7694105DReport run by Brian Saari at 21-FEB-2013 14:47:32
Abc 123
Abc 123
CD_001
All statuses
All statuses
R5003
R5003
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
01.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
02.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
03.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
04.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
05.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
06.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
07.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
08.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
09.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
10.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
11.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
12.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
13.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
15.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
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
18.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 21-FEB-2013 14:47:35 48Page
Report run by Brian Saari at 21-FEB-2013 14:47:35 49Page
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 21-FEB-2013 14:47:35 50Page
R267043013
Week_1
CD_001
R5003 Week 101
Study Diary Page number 1 Week 1
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
NONE
19-JAN-2010 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 21-FEB-2013 14:47:35 51Page
R267043613
Week_2
CD_001
R5003 Week 202
Study Diary Page number 2 Week 2
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
NONE
19-JAN-2010 18:30:13
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 21-FEB-2013 14:47:35 52Page
R267043813
Week_3
CD_001
R5003 Week 303
Study Diary Page number 3 Week 3
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:30:23
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 21-FEB-2013 14:47:35 53Page
R267044213
Week_4
CD_001
R5003 Week 404
Study Diary Page number 4 Week 4
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:30:34
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 21-FEB-2013 14:47:35 54Page
R267044313
Week_5
CD_001
R5003 Week 505
Study Diary Page number 5 Week 5
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:30:50
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 21-FEB-2013 14:47:35 55Page
R275014713
Week_6
CD_001
R5003 Week 606
Study Diary Page number 6 Week 6
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
NONE
19-JAN-2010 18:31:00
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 21-FEB-2013 14:47:35 56Page
R275014913
Week_7
CD_001
R5003 Week 707
Study Diary Page number 7 Week 7
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:31:14
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 21-FEB-2013 14:47:35 57Page
R275015113
Week_8
CD_001
R5003 Week 808
Study Diary Page number 8 Week 8
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:31:25
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 21-FEB-2013 14:47:35 58Page
R275015313
Week_9
CD_001
R5003 Week 909
Study Diary Page number 9 Week 9
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:33:49
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 21-FEB-2013 14:47:35 59Page
R275015413
Week_10
CD_001
R5003 Week 1010
Study Diary Page number 10 Week 10
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:34:00
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 21-FEB-2013 14:47:35 60Page
R275095513
Week_11
CD_001
R5003 Week 1111
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
N
Y
Y
N
05-JAN-2010 14:02:34
05-JAN-2010 14:03:20
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 21-FEB-2013 14:47:35 61Page
R275095513
Week_11
CD_001
R5003 Week 1111
Study Diary Page number 11 Week 11
DRUGSCR
6. I haveexperienced thefollowing AEs(3)1
N/A
19-JAN-2010 18:34:12
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 21-FEB-2013 14:47:35 62Page
R275095613
Week_12
CD_001
R5003 Week 1212
Study Diary Page number 12 Week 12
DRUGSCR
6. I haveexperienced thefollowing AEs(3)
Date
1
1
14-SEP-2009
N/A
21-SEP-2009
19-JAN-2010 18:34:24
05-JAN-2010 14:03:53
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 21-FEB-2013 14:47:35 63Page
R275095713
Week_13
CD_001
R5003 Week 1313
Study Diary Page number 13 Week 13
DRUGSCR
6. I haveexperienced thefollowing AEs(3)
Date
1
1
21-SEP-2009
N/A
28-SEP-2009
19-JAN-2010 18:34:33
05-JAN-2010 14:04:28
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 21-FEB-2013 14:47:35 64Page
R275095813
Week_14
CD_001
R5003 Week 1414
Study Diary Page number 14 Week 14
DRUGSCR
2. I have smokedonaverage_cigarettes p (1)
6. I haveexperienced thefollowing AEs(3)
Date
1
1
1
15
28-SEP-2009
10
N/A
05-OCT-2009
05-JAN-2010 14:04:48
19-JAN-2010 18:34:43
05-JAN-2010 14:04:48
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 21-FEB-2013 14:47:35 65Page
R275095913
Week_15
CD_001
R5003 Week 1515
Study Diary Page number 15 Week 15
DRUGSCR
6. I haveexperienced thefollowing AEs(3)
Date
1
1
05-OCT-2009
N/A
12-OCT-2009
19-JAN-2010 18:34:53
05-JAN-2010 14:05:17
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 21-FEB-2013 14:47:35 66Page
R275096013
Week_16
CD_001
R5003 Week 1616
Study Diary Page number 16 Week 16
DRUGSCR
2. I have smokedonaverage_cigarettes p (1)
6. I haveexperienced thefollowing AEs(3)
Date
1
1
1
10
12-OCT-2009
15
N/A
19-OCT-2009
05-JAN-2010 14:05:43
19-JAN-2010 18:35:03
05-JAN-2010 14:05:43
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 21-FEB-2013 14:47:35 67Page
R288100213
Week_17
CD_001
R5003 Follow-Up Wk 1717
Study Diary Page number 17 Follow-Up Wk 17
DRUGSCR
Date
1
02-NOV-2009
26-OCT-2009
14-JAN-2010 13:51:10
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 21-FEB-2013 14:47:35 68Page
R288100413
Week_18
CD_001
R5003 Follow-Up Wk 1818
Study Diary Page number 18 Follow-Up Wk 18
DRUGSCR
Date
1
09-NOV-2009
02-NOV-2009
14-JAN-2010 13:50:47
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 21-FEB-2013 14:47:35 69Page
Discrepancy Detail Report
Report run by Brian Saari at 21-FEB-2013 14:47:35 70Page
Deleted CRFs Report
