CRF Report for Study E7694105 ap… · Document #: Patient Site Visit Visit Date CRF CRF Page Section Section Date Qualifying Prompt Qualifying Value Section Visit Group # Group Name

CRF Report for Study E7694105Report run by Brian Saari at 05-MAR-2013 11:53:48

Abc 123

Abc 123

P3880_0342

All statuses

All statuses

R4091

R4091

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

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

09.LINKS




20.LINKS



32.OS.1

OverFlow Section For Document Number R288811913

UNABLE TO CONTACT SUBJECT1

32.LINKS




38.LINKS




39.LINKS




39.1.U1.LINKS




40.U1.LINKS



40.U3.LINKS



40.U4.LINKS



46.LINKS




Appendix: Audit and Discrepancy Information

Report run by Brian Saari at 05-MAR-2013 11:53:52 66Page


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.


R268233213

Page_05

P3880_0342

R4091 Screening05

Dm Page number 5 Screening

DM

Race

1 W

11-SEP-2009 10:04:02

Kim Freschly

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


R268233213

Page_05

P3880_0342

R4091 Screening05

Bm Page number 5 Screening

BM

Height

1

76.9

66.6

03-MAR-2010 10:55:00

Kim Freschly

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R296634613

Page_09

P3880_0342

R4091 Screening09

Mh Page number 9 Screening

MH1

Date of Onset

Date ofResolution

Diagnosis/Procedure

Does the subjecthave anyrelevant medic

Ongoing

Sequence Number

Date of Onset

Date ofResolution

Diagnosis/Procedure

Ongoing

Sequence Number

Date of Onset

Date ofResolution

1

1

1

1

1

1

2

2

2

2

2

3

3

12-AUG-2009

18-AUG-2009

VIRAL UPPER RESPIRATORYINFECTION

YES

1

06-JUL-2009

06-JUL-2009

HEADACHE

2

03-JUL-2009

08-JUL-2009

NO

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Kim Freschly

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R296634613

Page_09

P3880_0342

R4091 Screening09

Mh Page number 9 Screening

MH1

Diagnosis/Procedure

Ongoing

Sequence Number

3

3

3

STYE (HORDEOLUM) LEFTEYE

3

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

11-MAR-2010 14:33:27

Kim Freschly

Kim Freschly

Kim Freschly

Data Entry Error

Data Entry Error

Data Entry Error

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R288811913

Page_32

P3880_0342

R4091 Fu, Week 20 & 2432

Status Review Page number 32 Fu, Week 20 & 24

CHKYN

Comments(contacted byphone) (1)

Was Subjectcontacted bytelephone (1)

1

1

UNABLE TO CONTACTSUBJECT

NO

23-MAR-2010 11:13:32

19-JAN-2010 16:41:19

Lana Glaser

Kim Freschly

CRA Correction

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R288811913

Page_32

P3880_0342

R4091 Fu, Week 20 & 2432

Status Review Page number 32.1 Fu, Week 20 & 24

Section Header

DCM Blank flag

1

N

Y

23-MAR-2010 11:13:32

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R296644213

Page_38

P3880_0342

R4091 Fu, Week 2838

Status Review Page number 38 Fu, Week 28

CHKYN

Comments(compliant) (4)

If Subject wasnot compliant,approximat (5)

1

1

UNKNOWN

UNKNOWN

03-MAR-2010 11:08:10

23-MAR-2010 11:15:43

Kim Freschly

Lana Glaser

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


R268239013

Page_39

P3880_0342

R4091 Pcm39

Pcm Page number 39 Pcm

CM1

Start Date

Stop Date

1

1

07-JUL-2009

07-JUL-2009

06-JUL-2009

06-JUL-2009

11-MAR-2010 15:53:49

11-MAR-2010 15:53:49

Kim Freschly

Kim Freschly

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


R296646513

Page_39

P3880_0342

R4091 Pcm.1

Pcm Page number 39 Pcm.1

CM1

Stop Date

1

04-FEB-2010

03-FEB-2010

11-MAR-2010 15:56:30

Kim Freschly

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R288812713

Page_40

P3880_0342

R4091 Ae.3

Ae Page number 40 Ae.3

AE1

Adverse Event

1

COUGH

VIRAL UPPER RESPIRATORYINFECTION

03-MAR-2010 11:11:20

Kim Freschly

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R296647513

Page_40

P3880_0342

R4091 Ae.4


CRF

Document

1

R288812813

03-MAR-2010 11:10:57

Kim Freschly

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R296648413

Page_46

P3880_0342

R4091 Study Competion46

Ds Page number 46 Study Competion

DS

Other specify(2)

Reason forwithdrawal

1

1

NA

SUBJECT COMPLETED BUTWAS OUTSIDE THE WINDOW

OTHER

23-MAR-2010 11:16:50

23-MAR-2010 11:16:50

Lana Glaser

Lana Glaser

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


R268233213

P3880_0342 R409119325411

SCREENING

BM 5PAGE_05

Height 1

CURRENT

Confirmed

MANUAL

Resolved-Response Edited

66.6

Please review conversion value.

Source clarification needed. Source captured height in cm.

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:


R296634613

P3880_0342 R409182659411

SCREENING

MH 9PAGE_09

Does the subject have any relevant medic 1

CURRENT

Confirmed

MANUAL


NO

These all occurred after dosing. Please remove.

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:


R268238013

P3880_0342 R409119330211

IP, WEEK 6

STATUS REVIEW 20PAGE_20

Comments (how many cigarettes) 1

CURRENT

Confirmed

MANUAL


Per wk 6 check-in Q subject used NRT. Please add comment or update the source.

Per wk 6 check-in Q subject used NRT. Please add comment or update the source.

comment added to source

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:


R288811913

P3880_0342 R409189261811

FU, WEEK 20 & 2


Comments (contacted by phone) 1

CURRENT

Data value changed. Disc no longer applicable.

MANUAL


UNABLE TO CONTACT SUBJECT

Please provide a comment for why the assessment was not done.

comment added

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:


R296644213

P3880_0342 R409189262211

FU, WEEK 28


If Subject was not compliant, approximat 1

CURRENT


MANUAL


UNKNOWN

Please enter Unknown for result.

unknown added

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:


R268239013

P3880_0342 R409182801911

PCM

PCM 39PAGE_39

Stop Date 1

CURRENT

Confirmed

MANUAL


20090706

Please review stop date as subject had a ConMed for Headache on 07Jul09.

Source corrections needed.SOURCE 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:


R296646513

P3880_0342 R409182802711

PCM.1

PCM 39PAGE_39

Stop Date 1

CURRENT

Confirmed

MANUAL


20100203

Please review stop date of OTO conmed

Source correction needed.SOURCE 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:


R288812313

P3880_0342 R409182809511

AE.1

AE 40PAGE_40

Resolved Date 1

CURRENT

Confirmed

MANUAL


20090706

Pls review date as conmed was taken on 07Jul10

CONMED 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:


R296648413

P3880_0342 R409189263811

STUDY COMPETION

DS 46PAGE_46

Reason for withdrawal 1

CURRENT


MANUAL


OTHER

Please verify Week 28/Completion dates. If correct, Week 28 assessments occurred outsideof the +/- 7 day window of the scheduled visit date. Please update Study CompletionStatus to Other, specify. Specification should be: Subject completed but was out ofwindow.

comment added

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:


R288813013

Page_40

P3880_0342

R4091 Ae.5


CRF

1

03-MAR-2010 11:11:17

Kim Freschly

Data Entry Error

0

Deleted CRFs ReportDocument #:

Patient

Site

Visit

Visit Date

CRF

CRF Page #

Section Qualifying Prompt Qualifying Value Section Visit

Group # Group Name

FieldRow

Changed FromChanged To

OnBy

ReasonComment

Section Date

Documents

CRF Report for Study E7694105 ap… · Document #: Patient Site Visit Visit Date CRF CRF Page Section Section Date Qualifying Prompt Qualifying Value Section Visit Group # Group Name