CRF Report for Study E7694105DReport run by Brian Saari at 22-FEB-2013 12:59:22

Abc 123

Abc 123

L0689282_2

All statuses

All statuses

R2017

R2017

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

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

07.OS.1

OverFlow Section For Document Number R264382413

FLU STARTED 6-20-09 STARTED TAKING CIPROFLOXACIN 500MG 2 TIMES A DAY ON 6-24-09 UNTIL7-3-09.

1

07.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

Click here to navigate to discrepancy details 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

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

16.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 22-FEB-2013 12:59:26 43Page

Report run by Brian Saari at 22-FEB-2013 12:59:26 44Page

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 12:59:26 45Page

R264380913

Week_3

L0689282_2

R2017 Week 303

Study Diary Page number 3 Week 3

DRUGSCR

6. I haveexperienced thefollowing AEs(3)

7. I think theAE is related tothe snus (4)

1

1

AE

SUBJECT DID NOT ANSWERQUESTION #7

16-FEB-2010 13:20:33

16-FEB-2010 13:20:33

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 12:59:26 46Page

R264381113

Week_4

L0689282_2

R2017 Week 404

Study Diary Page number 4 Week 4

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NONE

16-FEB-2010 13:21:50

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 12:59:26 47Page

R264381613

Week_5

L0689282_2

R2017 Week 505

Study Diary Page number 5 Week 5

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NONE

16-FEB-2010 13:22:27

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 12:59:26 48Page

R264382413

Week_7

L0689282_2

R2017 Week 707

Study Diary Page number 7 Week 7

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

FLU

FLU STARTED 6-20-09STARTED TAKINGCIPROFLOXACIN 500MG 2TIMES A DAY ON 6-24-09UNTIL 7-3-09.

08-JAN-2010 12:49:16

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 12:59:26 49Page

R264382913

Week_9

L0689282_2

R2017 Week 909

Study Diary Page number 9 Week 9

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)

2. I have smokedonaverage_cigarettes p (1)

1

1

0

2-3

2-3

3

11-NOV-2009 10:47:34

02-APR-2010 13:44:40

Amanda Lynn

Krysia Magnuson 2-3 to 3.

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 22-FEB-2013 12:59:26 50Page

R288071013

Week_10

L0689282_2

R2017 Week 1010

Study Diary Page number 10 Week 10

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NA

16-FEB-2010 13:22:45

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 12:59:26 51Page

R288071213

Week_11

L0689282_2

R2017 Week 1111

Study Diary Page number 11 Week 11

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NA

16-FEB-2010 13:23:05

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 12:59:26 52Page

R288071413

Week_12

L0689282_2

R2017 Week 1212

Study Diary Page number 12 Week 12

DRUGSCR

6. I haveexperienced thefollowing AEs(3)

6. I haveexperienced thefollowing AEs(3)

1

1

NA

NA

NONE

16-FEB-2010 13:23:14

17-FEB-2010 14:26:51

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 12:59:26 53Page

R288071613

Week_13

L0689282_2

R2017 Week 1313

Study Diary Page number 13 Week 13

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NONE

16-FEB-2010 13:23:23

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 12:59:26 54Page

R288071813

Week_14

L0689282_2

R2017 Week 1414

Study Diary Page number 14 Week 14

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NA

16-FEB-2010 13:23:34

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 12:59:26 55Page

R288072013

Week_15

L0689282_2

R2017 Week 1515

Study Diary Page number 15 Week 15

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NA

16-FEB-2010 13:23:42

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 12:59:26 56Page

R288072313

Week_16

L0689282_2

R2017 Week 1616

Study Diary Page number 16 Week 16

DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

NA

16-FEB-2010 13:23:49

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 12:59:26 57Page

R264380913

L0689282_2

L0689282_2

R2017

R2017

66063211

66235711

WEEK 3

WEEK 3

STUDY DIARY

STUDY DIARY

3

3

WEEK_3

WEEK_3

7. I think the AE is related to the snus

7. I think the AE is related to the snus

1

1

CURRENT

CURRENT

Data value changed. Disc no longer applicable.

Confirmed

MANUAL

UNIVARIATE

Resolved-Response Edited

Resolved-Response Edited

Per source this question is not answered. Please add a comment in question 6 that thesubject did not answer question 7.

Value for 7. I think the AE is related to the snus has not been supplied

Please add that subject did not address question 6 either.

questions #7 wasn't answered by subject.

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 22-FEB-2013 12:59:26 58Page

R264381113

L0689282_2 R201766063311

WEEK 4

STUDY DIARY 4WEEK_4

6. I have experienced the following AEs 1

CURRENT

Data value changed. Disc no longer applicable.

MANUAL

Resolved-Response Edited

NONE

Please enter 'None' for weeks 4 and 5.

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 22-FEB-2013 12:59:26 59Page

R288071013

L0689282_2 R201766064411

WEEK 10

STUDY DIARY 10WEEK_10

6. I have experienced the following AEs 1

CURRENT

Data value changed. Disc no longer applicable.

MANUAL

Resolved-Response Edited

NA

Please complete question 6 verbatim for weeks 10-16.

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 22-FEB-2013 12:59:26 60Page

R288071413

L0689282_2 R201767217811

WEEK 12

STUDY DIARY 12WEEK_12

6. I have experienced the following AEs 1

CURRENT

Data value changed. Disc no longer applicable.

MANUAL

Resolved-Response Edited

NONE

Please verify entry. Per source diary 'None' is entered instead of NA. Please reviewand revise if applicable.

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 22-FEB-2013 12:59:26 61Page

Deleted CRFs Report