CRF Report for Study E7694105DReport run by Brian Saari at 22-FEB-2013 12:01:05
Abc 123
Abc 123
L0689282_2
All statuses
All statuses
R2003
R2003
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
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02.LINKS
Links to Discrepancy and Audit Sections
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03.LINKS
Links to Discrepancy and Audit Sections
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04.LINKS
Links to Discrepancy and Audit Sections
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05.LINKS
Links to Discrepancy and Audit Sections
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06.LINKS
Links to Discrepancy and Audit Sections
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Click here to navigate to discrepancy details for this CRF
07.LINKS
Links to Discrepancy and Audit Sections
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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
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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
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12.LINKS
Links to Discrepancy and Audit Sections
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13.LINKS
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14.LINKS
Links to Discrepancy and Audit Sections
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15.LINKS
Links to Discrepancy and Audit Sections
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16.LINKS
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21.LINKS
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Appendix: Audit and Discrepancy Information
Report run by Brian Saari at 22-FEB-2013 12:01:09 47Page
Report run by Brian Saari at 22-FEB-2013 12:01:09 48Page
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 22-FEB-2013 12:01:09 49Page
R244946313
Week_1
L0689282_2
R2003 Week 101
Study Diary Page number 1 Week 1
DRUGSCR
1. I have notsmoked anycigarettes at a(1)
5. Large (1g)(2)
5. Small (0.5g)(3)
1
1
1
CORRECT
4-7
INCORRECT
7
0
14-JAN-2010 10:13:12
14-JAN-2010 10:13:31
06-MAY-2009 10:06:13
Amanda Lynn
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 50Page
R244946613
Week_2
L0689282_2
R2003 Week 202
Study Diary Page number 2 Week 2
DRUGSCR
5. Large (1g)(2)1
4-7
7
14-JAN-2010 10:13:51
Amanda Lynn
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 22-FEB-2013 12:01:09 51Page
R244947013
Week_3
L0689282_2
R2003 Week 303
Study Diary Page number 3 Week 3
DRUGSCR
5. Large (1g)(2)1
4-7
7
14-JAN-2010 10:14:04
Amanda Lynn
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 22-FEB-2013 12:01:09 52Page
R244947213
Week_4
L0689282_2
R2003 Week 404
Study Diary Page number 4 Week 4
DRUGSCR
5. Large (1g)(2)1
4-5
5
14-JAN-2010 10:14:15
Amanda Lynn
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 22-FEB-2013 12:01:09 53Page
R244947413
Week_5
L0689282_2
R2003 Week 505
Study Diary Page number 5 Week 5
DRUGSCR
5. Large (1g)(2)1
2-4
4
14-JAN-2010 10:14:27
Amanda Lynn
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 22-FEB-2013 12:01:09 54Page
R249626813
Week_6
L0689282_2
R2003 Week 606
Study Diary Page number 6 Week 6
DRUGSCR
5. Small (0.5g)(3)
6. I haveexperienced thefollowing AEs(3)
1
1
1-4
4
NONE
14-JAN-2010 10:14:48
27-JAN-2010 12:50:23
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 55Page
R249627013
Week_7
L0689282_2
R2003 Week 707
Study Diary Page number 7 Week 7
DRUGSCR
5. Small (0.5g)(3)
6. I haveexperienced thefollowing AEs(3)
1
1
1-3
3
NONE
14-JAN-2010 10:15:01
27-JAN-2010 12:50:54
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 56Page
R249627213
Week_8
L0689282_2
R2003 Week 808
Study Diary Page number 8 Week 8
DRUGSCR
5. Small (0.5g)(3)
6. I haveexperienced thefollowing AEs(3)
1
1
5-9
9
NONE
14-JAN-2010 10:15:13
27-JAN-2010 12:51:03
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 57Page
R249627413
Week_9
L0689282_2
R2003 Week 909
Study Diary Page number 9 Week 9
DRUGSCR
5. Small (0.5g)(3)
5. Small (0.5g)(3)
6. I haveexperienced thefollowing AEs(3)
1
1
1
5-
5-7
5-7
7
NONE
22-SEP-2009 10:59:02
14-JAN-2010 10:15:49
27-JAN-2010 12:51:13
Amanda Lynn
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 58Page
R260402513
Week_10
L0689282_2
R2003 Week 1010
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
Y
N
N
Y
22-SEP-2009 10:47:29
11-NOV-2009 11:36:54
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 59Page
R260402513
Week_10
L0689282_2
R2003 Week 1010
Study Diary Page number 10 Week 10
DRUGSCR
5. Small (0.5g)(3)1
5
3-5
22-SEP-2009 10:59:18
Amanda Lynn
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 22-FEB-2013 12:01:09 60Page
R260402613
Week_11
L0689282_2
R2003 Week 1111
Study Diary Page number 11 Week 11
DRUGSCR
5. Small (0.5g)(3)
5. Small (0.5g)(3)
Date
Date
1
1
1
1
5
3-5
03-JUN-2009
10-JUN-2009
3-5
5
10-JUN-2009
03-JUN-2009
22-SEP-2009 10:59:30
14-JAN-2010 10:16:38
22-SEP-2009 10:48:24
11-NOV-2009 11:37:14
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 61Page
R260403013
Week_12
L0689282_2
R2003 Week 1212
Study Diary Page number 12 Week 12
DRUGSCR
5. Small (0.5g)(3)
5. Small (0.5g)(3)
Date
Date
1
1
1
1
5
3-5
10-JUN-2009
17-JUN-2009
3-5
5
17-JUN-2009
10-JUN-2009
22-SEP-2009 10:59:40
14-JAN-2010 10:17:52
22-SEP-2009 10:48:53
11-NOV-2009 11:38:19
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 62Page
R260403213
Week_13
L0689282_2
R2003 Week 1313
Study Diary Page number 13 Week 13
DRUGSCR
5. Small (0.5g)(3)
5. Small (0.5g)(3)
5. Small (0.5g)(3)
5. Small (0.5g)(3)
Date
Date
1
1
1
1
1
1
5
3
1-3
3-5
17-JUN-2009
24-JUN-2009
3
1-3
3-5
5
24-JUN-2009
17-JUN-2009
22-SEP-2009 10:49:10
22-SEP-2009 10:59:50
11-NOV-2009 11:38:54
14-JAN-2010 10:18:12
22-SEP-2009 10:49:10
11-NOV-2009 11:38:54
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 63Page
R260403813
Week_14
L0689282_2
R2003 Week 1414
Study Diary Page number 14 Week 14
DRUGSCR
2. I have smokedonaverage_cigarettes p (1)
2. I have smokedonaverage_cigarettes p (1)
3. I have smokedtobacco productsother (2)
3. I have smokedtobacco productsother (2)
3. Yes specify:(1)
3. Yes specify:(1)
5. Small (0.5g)(3)
5. Small (0.5g)(3)
Date
Date
1
1
1
1
1
1
1
1
1
1
0
1
NO
YES
BLACK N MILD AT BIRTHDAYPARTY
3
1-3
24-JUN-2009
01-JUL-2009
1
0
YES
NO
BLACK N MILD AT BIRTHDAYPARTY
1-3
3
01-JUL-2009
24-JUN-2009
22-SEP-2009 10:49:36
11-NOV-2009 11:39:16
22-SEP-2009 10:49:36
11-NOV-2009 11:39:16
22-SEP-2009 10:49:36
11-NOV-2009 11:39:16
22-SEP-2009 11:00:01
14-JAN-2010 10:18:24
22-SEP-2009 10:49:36
11-NOV-2009 11:39:16
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
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
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 22-FEB-2013 12:01:09 64Page
R260403913
Week_15
L0689282_2
R2003 Week 1515
Study Diary Page number 15 Week 15
DRUGSCR
2. I have smokedonaverage_cigarettes p (1)
2. I have smokedonaverage_cigarettes p (1)
3. I have smokedtobacco productsother (2)
3. I have smokedtobacco productsother (2)
3. Yes specify:(1)
3. Yes specify:(1)
5. Small (0.5g)(3)
5. Small (0.5g)(3)
Date
Date
1
1
1
1
1
1
1
1
1
1
1
0
YES
NO
BIRTHDAY PARTY
3
1-3
01-JUL-2009
08-JUL-2009
0
1
NO
YES
BLACK AND MILD ATBIRTHDAY PARTY
1-3
3
08-JUL-2009
01-JUL-2009
22-SEP-2009 10:50:15
11-NOV-2009 11:39:46
22-SEP-2009 10:50:15
11-NOV-2009 11:39:46
22-SEP-2009 10:50:15
11-NOV-2009 11:39:46
22-SEP-2009 11:00:12
14-JAN-2010 10:18:36
22-SEP-2009 10:50:15
11-NOV-2009 11:39:46
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
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
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 22-FEB-2013 12:01:09 65Page
R260404013
Week_16
L0689282_2
R2003 Week 1616
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
N
Y
Y
N
22-SEP-2009 10:50:43
22-SEP-2009 10:51:02
Amanda Lynn
Amanda Lynn
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 22-FEB-2013 12:01:09 66Page
R260404013
Week_16
L0689282_2
R2003 Week 1616
Study Diary Page number 16 Week 16
DRUGSCR
3. I have smokedtobacco productsother (2)
4. Did you usesmokelesstobacco product(3)
5. Large (1g)(2)
5. Small (0.5g)(3)
5. Small (0.5g)(3)
7. I think theAE is related tothe snus (4)
Date
1
1
1
1
1
1
1
1-3
15-JUL-2009
NO
NO
0
1-3
3
AE
08-JUL-2009
11-NOV-2009 11:40:23
11-NOV-2009 11:40:23
11-NOV-2009 11:40:23
11-NOV-2009 11:40:23
14-JAN-2010 10:18:52
11-NOV-2009 11:40:23
11-NOV-2009 11:40:23
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Data Entry Error
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 22-FEB-2013 12:01:09 67Page
R274973713
Week_21
L0689282_2
R2003 Follow-Up Wk 2121
Study Diary Page number 21 Follow-Up Wk 21
DRUGSCR
1. I have notsmoked anycigarettes at a(1)1
CORRECT
20-OCT-2009 12:09:17
Amanda Lynn
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 22-FEB-2013 12:01:09 68Page
R249626813
L0689282_2 R200349411011
WEEK 6
STUDY DIARY 6WEEK_6
6. I have experienced the following AEs 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
NONE
Per guidelines please enter 'None' for question 6 on diaries week 6-9.
Discrepancy Detail ReportDocument #:
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 22-FEB-2013 12:01:09 69Page
Deleted CRFs Report
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