crf report for study e7694105d...crf report for study e7694105d report run by brian saari at...

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

Abc 123

P3880_0342

All statuses

Report Parameters

Abc 123

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

04.LINKS

05.LINKS

06.LINKS

07.LINKS

Click here to navigate to discrepancy details for this CRF

08.LINKS

09.LINKS

10.LINKS

11.LINKS

12.LINKS

13.LINKS

14.LINKS

15.LINKS

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

16.LINKS

22.LINKS

28.LINKS

Appendix: Audit and Discrepancy Information

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

R288092013

Week_1

P3880_0342

R4045 Week 101

Study Diary Page number 1 Week 1

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

01-APR-2010 10:08:40

Krysia Magnuson 10-12 to 12.

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Qualifying Prompt Qualifying Value Section Visit

Group # Group Name

FieldRow

Changed From

Changed ToImpact onresequence

Reason

Comment

R288092113

Week_2

P3880_0342

R4045 Week 202

DRUGSCR

01-APR-2010 10:09:12

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288092513

Week_4

P3880_0342

R4045 Week 404

DRUGSCR

01-APR-2010 10:09:26

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288093013

Week_5

P3880_0342

R4045 Week 505

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

5. Large (1g)(2)

2 TO 3

01-APR-2010 10:30:35

Krysia Magnuson

2 TO 3 to 3.

8-10 to 10.

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288093213

Week_6

P3880_0342

R4045 Week 606

DRUGSCR

5. Large (1g)(2)

01-APR-2010 10:10:30

Krysia Magnuson

0-2 to 2.

6-8 to 8.

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288093413

Week_7

P3880_0342

R4045 Week 707

DRUGSCR

5. Large (1g)(2)

6. I haveexperienced thefollowing AEs(3)

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

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

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288093913

Week_8

P3880_0342

R4045 Week 808

DRUGSCR

5. Large (1g)(2)

4 TO 5

4-5 PER WEEK

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

Krysia Magnuson

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

5-7 to 7.

Data Entry Error

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288094513

Week_9

P3880_0342

R4045 Week 909

DRUGSCR

5. Large (1g)(2)

23-APR-2010 10:17:49

01-APR-2010 13:15:50

Kim Freschly

Data Entry Error

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288094713

Week_10

P3880_0342

R4045 Week 1010

DRUGSCR

5. Large (1g)(2)

01-APR-2010 10:11:03

Krysia Magnuson

1-3 to 3.

4-6 to 6.

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288094913

Week_11

P3880_0342

R4045 Week 1111

DRUGSCR

5. Large (1g)(2)

01-APR-2010 10:11:44

Krysia Magnuson

3-4 to 4.

5-7 to 7

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288095713

Week_12

P3880_0342

R4045 Week 1212

DRUGSCR

5. Large (1g)(2)1

01-APR-2010 13:48:21

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288095913

Week_13

P3880_0342

R4045 Week 1313

DRUGSCR

01-APR-2010 10:12:19

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288096113

Week_14

P3880_0342

R4045 Week 1414

DRUGSCR

01-APR-2010 10:12:40

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288096313

Week_15

P3880_0342

R4045 Week 1515

DRUGSCR

5. Large (1g)(2)

5. Small (0.5g)(3)

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

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288096513

Week_16

P3880_0342

R4045 Week 1616

DRUGSCR

01-APR-2010 10:29:58

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

R288097913

Week_22

P3880_0342

R4045 Follow-Up Wk 2222

Study Diary Page number 22 Follow-Up Wk 22

DRUGSCR

01-APR-2010 10:31:27

ODM/SEC

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

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

14-JAN-2010 13:48:11

Lana Glaser

Data Entry Error

Document #:

PatientSite

Visit Date

CRFCRF Page

SectionSection Date

Group # Group Name

FieldRow

Changed From

Reason

Comment

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:

Field:

Value Text:

Review Status:

Discrepancy:

Internal Comment:

Resolution Type:

Resolution Text:

Status:

Visit Date:

Section:

Patient:

Qualifying Value:

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

Please enter "4 to 5 per week" per source.

Document #:

Discrepancy ID:

Visit:

Field:

Value Text:

Review Status:

Discrepancy:

Internal Comment:

Resolution Type:

Resolution Text:

Status:

Visit Date:

Section:

Patient:

Qualifying Value:

R288094513

P3880_0342 R4045100163311

WEEK 9

STUDY DIARY 9WEEK_9

2. I have smoked on average_cigarettes p 1

CURRENT

Confirmed

MANUAL

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:

Field:

Value Text:

Review Status:

Discrepancy:

Internal Comment:

Resolution Type:

Resolution Text:

Status:

Visit Date:

Section:

Patient:

Qualifying Value:

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