CRF Report for Study E7694105DReport run by Brian Saari at 25-FEB-2013 15:10:52

Abc 123

Abc 123

P3880_0342

All statuses

All statuses

R4045

R4045

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.OS.1

OverFlow Section For Document Number R288092113

TRIED ABOUT 4 OR 51

02.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

Click here to navigate to discrepancy details for this CRF

08.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

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.OS.1

OverFlow Section For Document Number R288096513

STARTED TAKING 8/19 CIMI-FEM #1 40 MG SUBLINGUAL TABLET A DAY FOR HOT FLASHES ANDNIGHT SWEATS, TOOK MELATONIN 300 MCG 8-19-09

1

16.LINKS

Links to Discrepancy and Audit Sections

Click here to navigate to audit history for this CRF

22.LINKS

Links to Discrepancy and Audit Sections

Click here to navigate to audit history for this CRF

28.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 25-FEB-2013 15:10:56 49Page

Report run by Brian Saari at 25-FEB-2013 15:10:56 50Page

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 25-FEB-2013 15:10:56 51Page

R288092013

Week_1

P3880_0342

R4045 Week 101

Study Diary Page number 1 Week 1

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

10-12

12

01-APR-2010 10:08:40

Krysia Magnuson 10-12 to 12.

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 25-FEB-2013 15:10:56 52Page

R288092113

Week_2

P3880_0342

R4045 Week 202

Study Diary Page number 2 Week 2

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

10-12

12

01-APR-2010 10:09:12

Krysia Magnuson 10-12 to 12.

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 25-FEB-2013 15:10:56 53Page

R288092513

Week_4

P3880_0342

R4045 Week 404

Study Diary Page number 4 Week 4

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

10-12

12

01-APR-2010 10:09:26

Krysia Magnuson 10-12 to 12.

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 25-FEB-2013 15:10:56 54Page

R288093013

Week_5

P3880_0342

R4045 Week 505

Study Diary Page number 5 Week 5

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

5. Large (1g)(2)

1

1

2 TO 3

8-10

3

10

01-APR-2010 10:30:35

01-APR-2010 10:30:35

Krysia Magnuson

Krysia Magnuson

2 TO 3 to 3.

8-10 to 10.

ODM/SEC

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 25-FEB-2013 15:10:56 55Page

R288093213

Week_6

P3880_0342

R4045 Week 606

Study Diary Page number 6 Week 6

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

5. Large (1g)(2)

1

1

0-2

6-8

2

8

01-APR-2010 10:10:30

01-APR-2010 10:10:30

Krysia Magnuson

Krysia Magnuson

0-2 to 2.

6-8 to 8.

ODM/SEC

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 25-FEB-2013 15:10:56 56Page

R288093413

Week_7

P3880_0342

R4045 Week 707

Study Diary Page number 7 Week 7

DRUGSCR

5. Large (1g)(2)

6. I haveexperienced thefollowing AEs(3)

1

1

5-8

6-16-09 STARTED TAKINGMELATONIN BEFORE BEDTIME 30 MCG FOR INSOMNIA

8

6-16-09 STARTED TAKINGMELATONIN BEFORE BEDTIME 300 MCG FORINSOMNIA

01-APR-2010 13:15:28

03-MAR-2010 13:29:39

Krysia Magnuson

Lana Glaser

5-8 to 8.

ODM/SEC

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 25-FEB-2013 15:10:56 57Page

R288093913

Week_8

P3880_0342

R4045 Week 808

Study Diary Page number 8 Week 8

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

2. I have smokedonaverage_cigarettes p (1)

2. I have smokedonaverage_cigarettes p (1)

5. Large (1g)(2)

1

1

1

1

4 TO 5

0.71

4-5 PER WEEK

5-7

0.71

4-5 PER WEEK

0.71

7

14-JAN-2010 13:34:26

03-MAR-2010 15:19:05

05-APR-2010 12:39:28

01-APR-2010 13:16:03

Lana Glaser

Lana Glaser

Krysia Magnuson

Krysia Magnuson

4-5 PER WEEK to0.71. (convertedweekly value todaily)

5-7 to 7.

Data Entry Error

Data Entry Error

ODM/SEC

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 25-FEB-2013 15:10:56 58Page

R288094513

Week_9

P3880_0342

R4045 Week 909

Study Diary Page number 9 Week 9

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

5. Large (1g)(2)

1

1

63

5-8

2.29

8

23-APR-2010 10:17:49

01-APR-2010 13:15:50

Kim Freschly

Krysia Magnuson 5-8 to 8.

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 25-FEB-2013 15:10:56 59Page

R288094713

Week_10

P3880_0342

R4045 Week 1010

Study Diary Page number 10 Week 10

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

5. Large (1g)(2)

1

1

1-3

4-6

3

6

01-APR-2010 10:11:03

01-APR-2010 10:11:03

Krysia Magnuson

Krysia Magnuson

1-3 to 3.

4-6 to 6.

ODM/SEC

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 25-FEB-2013 15:10:56 60Page

R288094913

Week_11

P3880_0342

R4045 Week 1111

Study Diary Page number 11 Week 11

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

5. Large (1g)(2)

1

1

3-4

5-7

4

7

01-APR-2010 10:11:44

01-APR-2010 10:11:44

Krysia Magnuson

Krysia Magnuson

3-4 to 4.

5-7 to 7

ODM/SEC

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 25-FEB-2013 15:10:56 61Page

R288095713

Week_12

P3880_0342

R4045 Week 1212

Study Diary Page number 12 Week 12

DRUGSCR

5. Large (1g)(2)1

4-7

7

01-APR-2010 13:48:21

Krysia Magnuson 4-7 to 7.

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 25-FEB-2013 15:10:56 62Page

R288095913

Week_13

P3880_0342

R4045 Week 1313

Study Diary Page number 13 Week 13

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

3-4

4

01-APR-2010 10:12:19

Krysia Magnuson 3-4 to 4.

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 25-FEB-2013 15:10:56 63Page

R288096113

Week_14

P3880_0342

R4045 Week 1414

Study Diary Page number 14 Week 14

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

5-6

6

01-APR-2010 10:12:40

Krysia Magnuson 5-6 to 6.

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 25-FEB-2013 15:10:56 64Page

R288096313

Week_15

P3880_0342

R4045 Week 1515

Study Diary Page number 15 Week 15

DRUGSCR

5. Large (1g)(2)

5. Small (0.5g)(3)

1

1

3-5

5

0

01-APR-2010 13:49:23

14-JAN-2010 13:40:11

Krysia Magnuson

Lana Glaser

3-5 to 5.

ODM/SEC

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 25-FEB-2013 15:10:56 65Page

R288096513

Week_16

P3880_0342

R4045 Week 1616

Study Diary Page number 16 Week 16

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

4-6

6

01-APR-2010 10:29:58

Krysia Magnuson 4-6 to 6.

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 25-FEB-2013 15:10:56 66Page

R288097913

Week_22

P3880_0342

R4045 Follow-Up Wk 2222

Study Diary Page number 22 Follow-Up Wk 22

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

14-16

16

01-APR-2010 10:31:27

Krysia Magnuson 14-16 to 16.

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 25-FEB-2013 15:10:56 67Page

R288099113

Week_28

P3880_0342

R4045 Follow-Up Wk 2828

Study Diary Page number 28 Follow-Up Wk 28

DRUGSCR

3. I have smokedtobacco productsother (2)1

NO

14-JAN-2010 13:48:11

Lana Glaser

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 25-FEB-2013 15:10:56 68Page

R288093413

P3880_0342 R404576434111

WEEK 7

STUDY DIARY 7WEEK_7

6. I have experienced the following AEs 1

CURRENT

Confirmed

MANUAL

Resolved-Response Edited

6-16-09 STARTED TAKING MELATONIN BEFORE BED TIME 300 MCG FOR INSOMNIA

Please verify melatonin was 300 mcg, not 30.

corrected

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 25-FEB-2013 15:10:56 69Page

R288093913

P3880_0342 R404576434211

WEEK 8

STUDY DIARY 8WEEK_8

2. I have smoked on average_cigarettes p 1

CURRENT

Data value changed. Disc no longer applicable.

MANUAL

Resolved-Response Edited

0.71

Please enter "4 to 5 per week" per 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 25-FEB-2013 15:10:56 70Page

R288094513

P3880_0342 R4045100163311

WEEK 9

STUDY DIARY 9WEEK_9

2. I have smoked on average_cigarettes p 1

CURRENT

Confirmed

MANUAL

Resolved-Response Edited

2.29

Please review source - (7+9). Perhaps result would be 16/7 or 2.29. This would be morein line with values for other weeks.

Please route query to DM

Verified. JLM 27Apr2010

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 25-FEB-2013 15:10:56 71Page

Deleted CRFs Report