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

Links to Discrepancy and Audit Sections

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02.LINKS

Links to Discrepancy and Audit Sections

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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

Click here to navigate to discrepancy details 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

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21.LINKS

Links to Discrepancy and Audit Sections

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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