CRF Report for Study E7694105D - accessdata.fda.gov fileCRF Report for Study E7694105D Report run by...

CRF Report for Study E7694105DReport run by Brian Saari at 22-FEB-2013 10:36:37

Abc 123

Abc 123

CP_001

All statuses

All statuses

R3006

R3006

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

21.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

22.LINKS



Click here to navigate to discrepancy details for this CRF

23.LINKS



24.LINKS



26.LINKS



27.LINKS



28.LINKS



Appendix: Audit and Discrepancy Information

Report run by Brian Saari at 22-FEB-2013 10:36:40 36Page


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.


R274826813

Week_21

CP_001

R3006 Follow-Up Wk 2121

Study Diary Page number 21 Follow-Up Wk 21

DRUGSCR

2. I have smokedonaverage_cigarettes p (1)


1

1

63

LESS THAN 1

LESS THAN 1

1

18-NOV-2009 15:55:40

02-APR-2010 13:42:13

Heather Aiona

Krysia Magnuson LESS THAN 1 to 1.

InvestigatorCorrection

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


R274826913

Week_22

CP_001



DRUGSCR



1

1

2

LESS THAN 1

LESS THAN 1

1

18-NOV-2009 15:57:55

02-APR-2010 13:42:31

Heather Aiona



ODM/SEC

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R274827013

Week_23

CP_001



DRUGSCR



1

1

2

LESS THAN 1

LESS THAN 1

1

18-NOV-2009 15:59:39

02-APR-2010 13:42:40

Heather Aiona



ODM/SEC

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R274827113

Week_24

CP_001



DRUGSCR



1

1

1

LESS THAN 1

LESS THAN 1

1

18-NOV-2009 16:00:25

02-APR-2010 13:42:49

Heather Aiona



ODM/SEC

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R274827213

Week_25

CP_001



DRUGSCR

4. Did you usesmokelesstobacco product(3)

4. Yes specify:(2)

1

1

NO

YES

MELLOW CAMEL STICKS-3

18-NOV-2009 16:05:49

18-NOV-2009 16:05:49

Heather Aiona

Heather Aiona



1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R274827313

Week_26

CP_001



DRUGSCR



4. Did you usesmokelesstobacco product(3)

4. Yes specify:(2)

1

1

1

1

1

LESS THAN 1

NO

LESS THAN 1

1

YES

CAMELSTICKS MELLOW - 3

18-NOV-2009 16:01:13

02-APR-2010 13:43:03

19-OCT-2009 17:27:38

19-OCT-2009 17:27:38

Heather Aiona

Krysia Magnuson

Marilyn Mindolovich

Marilyn Mindolovich

LESS THAN 1 to 1.


ODM/SEC



1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R274827513

Week_27

CP_001



DRUGSCR



1

1

1

LESS THAN 1

LESS THAN 1

1

18-NOV-2009 16:02:02

02-APR-2010 13:43:14

Heather Aiona



ODM/SEC

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R274827613

Week_28

CP_001



DRUGSCR



1

1

3

LESS THAN 1

LESS THAN 1

1

18-NOV-2009 16:02:58

02-APR-2010 13:43:24

Heather Aiona



ODM/SEC

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R274826813

CP_001 R30061779452713

FOLLOW-UP WK 21

STUDY DIARY 21WEEK_21

2. I have smoked on average_cigarettes p 1

CURRENT

Data value changed. Disc no longer applicable.

MANUAL

Resolved-Response Edited

1

Please verify amount, can enter decimal for cig less than 1 / day.

amount 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:


R274826913

CP_001 R30061779453013

FOLLOW-UP WK 22


2. I have smoked on average_cigarettes p 1

CURRENT


MANUAL


1

Please verify cig. amounts. The subject has used the greater than sign instead of theless than sign and then wrote in a total number of cigs. Please clarify if the total isfor the week. Please verify with subject and document verification on source for alldiary entries weeks 22-28.

corrected. Pt. smoked 2 per this week. less than 1 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:


R274827213

CP_001 R30061796444913

FOLLOW-UP WK 25


4. Did you use smokeless tobacco product 1

CURRENT


MANUAL


YES

Per diary subject used camel sticks-mallow times 3.

corrected

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:


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