CRF Report for Study E7694105DReport run by Brian Saari at 25-FEB-2013 10:22:01

Abc 123

Abc 123

P3880_0342

All statuses

All statuses

R4021

R4021

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

Click here to navigate to discrepancy details for this CRF

02.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

03.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

04.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

05.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

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

Appendix: Audit and Discrepancy Information

Report run by Brian Saari at 25-FEB-2013 10:22:05 38Page

Report run by Brian Saari at 25-FEB-2013 10:22:05 39Page

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 10:22:05 40Page

R246562513

Week_1

P3880_0342

R4021 Week 101

Study Diary Page number 1 Week 1

DRUGSCR

5. Small (0.5g)(3)

6. I haveexperienced thefollowing AEs(3)

1

1

SINUSES

1 BOX

SINUSES IN BED THURSDAY,FRIDAY AND SATURDAY,SHOT DOCTORS 4/3/09FRIDAY

06-NOV-2009 11:21:24

06-NOV-2009 11:22:03

Lana Glaser

Lana Glaser

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 25-FEB-2013 10:22:05 41Page

R246563213

Week_2

P3880_0342

R4021 Week 202

Study Diary Page number 2 Week 2

DRUGSCR

5. Large (1g)(2)

5. Small (0.5g)(3)

1

1

1

0

1 BOX

06-NOV-2009 11:26:45

06-NOV-2009 11:26:30

Lana Glaser

Lana Glaser

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 25-FEB-2013 10:22:05 42Page

R246563513

Week_3

P3880_0342

R4021 Week 303

Study Diary Page number 3 Week 3

DRUGSCR

5. Large (1g)(2)

5. Small (0.5g)(3)

1

1

1/2 BOX

1 BOX

06-NOV-2009 11:27:46

06-NOV-2009 11:27:46

Lana Glaser

Lana Glaser

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 25-FEB-2013 10:22:05 43Page

R246563713

Week_4

P3880_0342

R4021 Week 404

Study Diary Page number 4 Week 4

DRUGSCR

5. Large (1g)(2)

5. Small (0.5g)(3)

1

1

1/2BOX

1 BOX

06-NOV-2009 11:29:40

06-NOV-2009 11:29:40

Lana Glaser

Lana Glaser

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 25-FEB-2013 10:22:05 44Page

R246563813

Week_5

P3880_0342

R4021 Week 505

Study Diary Page number 5 Week 5

DRUGSCR

5. Small (0.5g)(3)1

1 BOX

06-NOV-2009 11:30:10

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 10:22:05 45Page

R278139813

Week_13

P3880_0342

R4021 Week 1313

Study Diary Page number 13 Week 13

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

10 TO 15

15

01-APR-2010 10:03:36

Krysia Magnuson 10 TO 15 to 15

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 10:22:05 46Page

R278140013

Week_14

P3880_0342

R4021 Week 1414

Study Diary Page number 14 Week 14

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

10 TO 15

15

01-APR-2010 10:04:00

Krysia Magnuson 10 TO 15 to 15

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 10:22:05 47Page

R278140213

Week_15

P3880_0342

R4021 Week 1515

Study Diary Page number 15 Week 15

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

10 TO 15

15

01-APR-2010 10:04:09

Krysia Magnuson 10 TO 15 to 15

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 10:22:05 48Page

R246562513

P3880_0342

P3880_0342

R4021

R4021

1781640613

1730954813

WEEK 1

WEEK 1

STUDY DIARY

STUDY DIARY

1

1

WEEK_1

WEEK_1

6. I have experienced the following AEs 1

CURRENT

CURRENT

Data value changed. Disc no longer applicable.

Data value changed. Disc no longer applicable.

MANUAL

MANUAL HEADER

Resolved-Response Edited

Resolved-Response Edited

SINUSES IN BED THURSDAY, FRIDAY AND SATURDAY, SHOT DOCTORS 4/3/09 FRIDAY

Pls add all info from diary

Please complete

added all info from diary

Source update requested

Discrepancy Detail ReportDocument #:

Discrepancy ID:

Discrepancy ID:

Visit:

Visit:

CRF:

CRF:

Field:

Field:

Value Text:

Value Text:

Type:

Type:

Review Status:

Review Status:

Discrepancy:

Discrepancy:

Internal Comment:

Internal Comment:

Resolution Type:

Resolution Type:

Resolution Text:

Resolution Text:

Status:

Status:

Site:

Site:

Visit Date:

Visit Date:

Section:

Section:

Patient:

Patient:

Qualifying Value:

Qualifying Value:

Row:

Row:

Report run by Brian Saari at 25-FEB-2013 10:22:05 49Page

R246563213

P3880_0342

P3880_0342

R4021

R4021

1781640713

1730989013

WEEK 2

WEEK 2

STUDY DIARY

STUDY DIARY

2

2

WEEK_2

WEEK_2

5. Large (1g) 1

CURRENT

CURRENT

Data value changed. Disc no longer applicable.

Data value changed. Disc no longer applicable.

MANUAL

MANUAL HEADER

Resolved-Response Edited

Resolved-Response Edited

0

Pls review value

Please complete

corrected

Source correction requested

Document #:

Discrepancy ID:

Discrepancy ID:

Visit:

Visit:

CRF:

CRF:

Field:

Field:

Value Text:

Value Text:

Type:

Type:

Review Status:

Review Status:

Discrepancy:

Discrepancy:

Internal Comment:

Internal Comment:

Resolution Type:

Resolution Type:

Resolution Text:

Resolution Text:

Status:

Status:

Site:

Site:

Visit Date:

Visit Date:

Section:

Section:

Patient:

Patient:

Qualifying Value:

Qualifying Value:

Row:

Row:

Report run by Brian Saari at 25-FEB-2013 10:22:05 50Page

R246563513

P3880_0342 R40211730989313

WEEK 3

STUDY DIARY 3WEEK_3

CURRENT

Data value changed. Disc no longer applicable.

MANUAL HEADER

Resolved-Response Edited

Please complete

Source correction requested

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 10:22:05 51Page

R246563713

P3880_0342 R40211730989613

WEEK 4

STUDY DIARY 4WEEK_4

CURRENT

Data value changed. Disc no longer applicable.

MANUAL HEADER

Resolved-Response Edited

Please complete

Source corrections requested

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 10:22:05 52Page

R246563813

P3880_0342 R40211730990113

WEEK 5

STUDY DIARY 5WEEK_5

CURRENT

Data value changed. Disc no longer applicable.

MANUAL HEADER

Resolved-Response Edited

Please complete

Source correction requested

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 10:22:05 53Page

Deleted CRFs Report