CRF Report for Study E7694105D...CP_001 R3028 Follow-Up Wk 21 21 Study Diary Page number 21...

CRF Report for Study E7694105DReport run by Brian Saari at 22-FEB-2013 11:08:46

Abc 123

Abc 123

CP_001

All statuses

All statuses

R3028

R3028

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




03.LINKS




04.LINKS




05.LINKS




06.LINKS




07.LINKS




08.LINKS




09.LINKS



21.LINKS



Appendix: Audit and Discrepancy Information

Report run by Brian Saari at 22-FEB-2013 11:08:50 40Page


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.


R266317813

Week_1

CP_001

R3028 Week 101

Study Diary Page number 1 Week 1

DRUGSCR

6. I haveexperienced thefollowing AEs(3)

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

1

1

AE

SUBJECT DID NOT ANSWERQUESTION 7 IN DIARY

19-FEB-2010 09:10:13

19-FEB-2010 09:10:13

Tricia Hunt

Tricia Hunt

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


R266317913

Week_2

CP_001

R3028 Week 202


DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

30

4

19-FEB-2010 09:17:11

Tricia Hunt

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266318013

Week_3

CP_001

R3028 Week 303


DRUGSCR

2. I have smokedonaverage_cigarettes p (1)1

30

4

19-FEB-2010 09:17:54

Tricia Hunt

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266318113

Week_4

CP_001

R3028 Week 404


DRUGSCR

6. I haveexperienced thefollowing AEs(3)1

STRESS!

19-FEB-2010 09:23:13

Tricia Hunt

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266318213

Week_5

CP_001

R3028 Week 505

CRF Header

DCI Blank Flag

1

Y

N

31-AUG-2009 18:54:45

Tricia Hunt

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266318313

Week_6

CP_001

R3028 Week 606


DRUGSCR

2. I have smokedonaverage_cigarettes p (1)



1

1

1

3

2-3

2-3

3

NONE

19-FEB-2010 09:24:03

02-APR-2010 13:43:55

19-FEB-2010 09:24:27

Tricia Hunt

Krysia Magnuson

Tricia Hunt

2-3 to 3.

Data Entry Error

ODM/SEC

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266318413

Week_7

CP_001

R3028 Week 707


DRUGSCR

7. I think theAE is related tothe snus (4)1

CORRECT

AE

19-FEB-2010 09:25:29

Tricia Hunt

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266318513

Week_8

CP_001

R3028 Week 808


DRUGSCR



1

1

21

5

NONE

19-FEB-2010 09:31:51

19-FEB-2010 09:32:26

Tricia Hunt

Tricia Hunt

Data Entry Error

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266318613

Week_9

CP_001

R3028 Week 909


DRUGSCR

5. Large (1g)(2)

5. Small (0.5g)(3)


1

1

1

0

0

5

5

NONE

19-FEB-2010 11:12:35

19-FEB-2010 11:12:35

19-FEB-2010 09:32:54

Tricia Hunt

Tricia Hunt

Tricia Hunt

Informationupdated withsubject.

Data Entry Error

Data Entry Error

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R281368313

Week_21

CP_001

R3028 Follow-Up Wk 2121

Study Diary Page number 21 Follow-Up Wk 21

DRUGSCR

1. I have notsmoked anycigarettes at a(1)1

INCORRECT

23-NOV-2009 12:51:33

Marilyn Mindolovich

InvestigatorCorrection

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R266317813

CP_001

CP_001

R3028

R3028

68655411

70686211

WEEK 1

WEEK 1

STUDY DIARY

STUDY DIARY

1

1

WEEK_1

WEEK_1

7. I think the AE is related to the snus


1

1

CURRENT

CURRENT

Data value changed. Disc no longer applicable.


MANUAL

UNIVARIATE

Resolved-Response Edited


Please uncheck this box and enter comment in #6 that subject did not answer question #7.

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

Subject did not check a box on question 7.

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:


R266317913

CP_001 R302868656011

WEEK 2

STUDY DIARY 2WEEK_2

2. I have smoked on average_cigarettes p 1

CURRENT


MANUAL


4

Please review source for correct amount of cigs per day.

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:


R266318013

CP_001 R302868660111

WEEK 3

STUDY DIARY 3WEEK_3


CURRENT


MANUAL


4

Please review source for correct amount of cigs / day.

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:


R266318113

CP_001 R302868660411

WEEK 4

STUDY DIARY 4WEEK_4

6. I have experienced the following AEs 1

CURRENT


MANUAL


STRESS!

Please add verbatim from diary.

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:


R266318213

CP_001

CP_001

CP_001

CP_001

R3028

R3028

R3028

R3028

1734777913

1734778013

1734778113

1734778213

WEEK 5

WEEK 5

WEEK 5

WEEK 5

STUDY DIARY

STUDY DIARY

STUDY DIARY

STUDY DIARY

5

5

5

5

WEEK_5

WEEK_5

WEEK_5

WEEK_5

1. I have not smoked any cigarettes at a

2. I have smoked on average_cigarettes p

3. I have smoked tobacco products other

4. Did you use smokeless tobacco product

1

1

1

1

CURRENT

CURRENT

CURRENT

CURRENT

No Action Required

No Action Required

No Action Required

No Action Required

UNIVARIATE

UNIVARIATE

UNIVARIATE

UNIVARIATE





Value for 1. I have not smoked any cigarettes at a has not been supplied

Value for 2. I have smoked on average_cigarettes p has not been supplied

Value for 3. I have smoked tobacco products other has not been supplied

Value for 4. Did you use smokeless tobacco product has not been supplied

Subject did not complete all information for week 5




Document #:

Discrepancy ID:

Discrepancy ID:

Discrepancy ID:

Discrepancy ID:

Visit:

Visit:

Visit:

Visit:

CRF:

CRF:

CRF:

CRF:

Field:

Field:

Field:

Field:

Value Text:

Value Text:

Value Text:

Value Text:

Type:

Type:

Type:

Type:

Review Status:

Review Status:

Review Status:

Review Status:

Discrepancy:

Discrepancy:

Discrepancy:

Discrepancy:

Internal Comment:

Internal Comment:

Internal Comment:

Internal Comment:

Resolution Type:

Resolution Type:

Resolution Type:

Resolution Type:

Resolution Text:

Resolution Text:

Resolution Text:

Resolution Text:

Status:

Status:

Status:

Status:

Site:

Site:

Site:

Site:

Visit Date:

Visit Date:

Visit Date:

Visit Date:

Section:

Section:

Section:

Section:

Patient:

Patient:

Patient:

Patient:

Qualifying Value:

Qualifying Value:

Qualifying Value:

Qualifying Value:

Row:

Row:

Row:

Row:


R266318213

CP_001

CP_001

CP_001

R3028

R3028

R3028

1734778313

1734778413

1734778513

WEEK 5

WEEK 5

WEEK 5

STUDY DIARY

STUDY DIARY

STUDY DIARY

5

5

5

WEEK_5

WEEK_5

WEEK_5

5. Large (1g)

5. Small (0.5g)


1

1

1

CURRENT

CURRENT

CURRENT

No Action Required

No Action Required

No Action Required

UNIVARIATE

UNIVARIATE

UNIVARIATE




Value for 5. Large (1g) has not been supplied

Value for 5. Small (0.5g) has not been supplied

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




Discrepancy ID:

Discrepancy ID:

Discrepancy ID:

Visit:

Visit:

Visit:

CRF:

CRF:

CRF:

Field:

Field:

Field:

Value Text:

Value Text:

Value Text:

Type:

Type:

Type:

Review Status:

Review Status:

Review Status:

Discrepancy:

Discrepancy:

Discrepancy:

Internal Comment:

Internal Comment:

Internal Comment:

Resolution Type:

Resolution Type:

Resolution Type:

Resolution Text:

Resolution Text:

Resolution Text:

Status:

Status:

Status:

Site:

Site:

Site:

Visit Date:

Visit Date:

Visit Date:

Section:

Section:

Section:

Patient:

Patient:

Patient:

Qualifying Value:

Qualifying Value:

Qualifying Value:

Row:

Row:

Row:


R266318313

CP_001 R302868892511

WEEK 6

STUDY DIARY 6WEEK_6


CURRENT


MANUAL


3

Please enter verbatim from diary question 2 and 6.

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:


R266318413

CP_001 R302868892611

WEEK 7

STUDY DIARY 7WEEK_7

7. I think the AE is related to the snus 1

CURRENT


MANUAL


AE

Please see source for correct response.

Unable to close as resolved

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:


R266318513

CP_001 R302868892911

WEEK 8

STUDY DIARY 8WEEK_8


CURRENT


MANUAL


5

Please see source for correct response.

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:


Deleted CRFs Report

CRF Report for Study E7694105D...CP_001 R3028 Follow-Up Wk 21 21 Study Diary Page number 21...

Documents

Transcript of CRF Report for Study E7694105D...CP_001 R3028 Follow-Up Wk 21 21 Study Diary Page number 21...