CRF Report for Study E7694105 - Food and Drug …...CRF Report for Study E7694105 Report run by...

CRF Report for Study E7694105Report run by Brian Saari at 06-MAR-2013 16:13:40

Abc 123

Abc 123

CD_001

All statuses

All statuses

R5020

R5020

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

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




04.OS.1

OverFlow Section For Document Number R259445213

LAST DENTAL CHECK-UP OVER 5 YEARS AGO1

04.LINKS




09.LINKS




10.LINKS



14.LINKS



16.OS.1


MESSAGE WAS LEFT FOR SUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED1



16.LINKS




17.LINKS




18.LINKS



20.LINKS



21.OS.1


UNABLE TO CONTACT AFTER 3 ATTEMPTS1

21.LINKS




27.LINKS




36.LINKS



39.LINKS



39.1.U1.LINKS



39.1.U3.LINKS




39.1.U4.LINKS




39.1.U5.LINKS




39.1.U6.LINKS




39.1.U7.LINKS



40.LINKS



43.LINKS



Appendix: Audit and Discrepancy Information

Report run by Brian Saari at 06-MAR-2013 16:13:44 81Page


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.


R259337813

Page_02

CD_001

R5020 Screening02

Ic Page number 2 Screening

IE

InclusionCriteria Answer6

YES

NO

04-DEC-2009 13:43:01

Sharon Ladenes

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


R259352813

Page_03

CD_001

R5020 Screening03

Ec Page number 3 Screening

IE

ExclusionCriteria Answer

ExclusionCriteria Answer

3

3

NO

YES

YES

NO

23-JUL-2009 18:15:00

04-DEC-2009 13:43:35

Sharon Ladenes

Sharon Ladenes

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


R259445213

Page_04

CD_001

R5020 Screening04

Elig Page number 4 Screening

IE

Category

Category

Did the subjectmeet all of theinclusio

ExemptionGranted?

Explanation (1)

If Yes, DateGranted

Inclusion/Exclusion No.



1

1

1

1

1

1

1

1

1

E

YES

03

06

E

I

NO

YES

LAST DENTAL CHECK-UPOVER 5 YEARS AGO

21-JUL-2009

03

06

6

23-JUL-2009 18:15:54

04-DEC-2009 13:44:06

23-JUL-2009 18:14:18

23-JUL-2009 18:15:54

23-JUL-2009 18:15:54

23-JUL-2009 18:15:54

23-JUL-2009 18:15:54

04-DEC-2009 13:44:06

17-MAR-2010 18:07:35

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Krysia Magnuson 06 to 6. KAY17Mar2010.

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Data Entry Error

ODM/SEC

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R259447413

Page_09

CD_001

R5020 Screening09

Mh Page number 9 Screening

MH1

Date of Onset

Date of Onset

Date ofResolution

Date ofResolution

Diagnosis/Procedure

Diagnosis/Procedure

Ongoing

Ongoing

Sequence Number

Sequence Number

Date of Onset

Date of Onset

Date ofResolution

Date ofResolution

1

1

1

1

1

1

1

1

1

1

2

2

2

2

00-APR-2009

00-APR-2009

GALL BLADDER REMOVAL

1

00-MAY-2007

00-MAY-2007

<Row Deleted>

00-00-2007

<Row Deleted>

<Row Deleted>

OSTEOARTHRITIS

<Row Deleted>

CHECKED

<Row Deleted>

1

<Row Deleted>

00-00-1996

<Row Deleted>

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R259447413

Page_09

CD_001

R5020 Screening09


MH1

Diagnosis/Procedure

Diagnosis/Procedure

Ongoing

Ongoing

Sequence Number

Sequence Number

Diagnosis/Procedure

Date of Onset

Date of Onset

Date ofResolution

Date ofResolution

Diagnosis/Procedure

Diagnosis/Procedure

Ongoing

Ongoing

2

2

2

2

2

2

5

6

6

6

6

6

6

6

6

LEFT HIP REPLACEMENT

2

OVARIAN CYST

00-00-1997

00-00-1998

HOT FLASHES

<Row Deleted>

POST MENOPAUSAL

<Row Deleted>

CHECKED

<Row Deleted>

2

OVARIAN CYST (RIGHTOVARY)

<Row Deleted>

00-00-2007

<Row Deleted>

<Row Deleted>

RECURRENT JOINT PAIN

<Row Deleted>

CHECKED

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

11-MAR-2010 14:42:47

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Stephanie Felton

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R259447413

Page_09

CD_001

R5020 Screening09


MH1

Sequence Number

Sequence Number

Date of Onset

Date of Onset

Date of Onset

Date of Onset

Date of Onset

Date ofResolution

Date ofResolution

Date ofResolution

Date ofResolution

Diagnosis/Procedure

Diagnosis/Procedure

Diagnosis/Procedure

Diagnosis/Procedure

6

6

7

7

7

7

7

7

7

7

7

7

7

7

7

6

00-00-2007

00-APR-2008

OSTEOARTHRITIS

ALLERGIES

<Row Deleted>

6

<Row Deleted>

<Row Deleted>

00-APR-2008

01-APR-2008

<Row Deleted>

<Row Deleted>

<Row Deleted>

ALLERGIES

<Row Deleted>

BACK SPASMS

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-JAN-2010 16:08:08

11-FEB-2010 12:56:24

11-FEB-2010 12:56:24

03-MAR-2010 12:44:09

04-DEC-2009 13:36:13

04-JAN-2010 16:08:08

11-FEB-2010 12:56:24

11-FEB-2010 12:56:24

04-DEC-2009 13:36:13

04-JAN-2010 16:08:08

11-FEB-2010 12:56:24

11-FEB-2010 12:56:24

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R259447413

Page_09

CD_001

R5020 Screening09


MH1

Diagnosis/Procedure

Ongoing

Ongoing

Ongoing

Ongoing

Sequence Number

Sequence Number

Sequence Number

Sequence Number

Date of Onset

Date of Onset

Date of Onset

Date of Onset

Date of Onset

Date of Onset

Date of Onset

7

7

7

7

7

7

7

7

7

8

8

8

8

8

8

8

BACK SPASMS

CHECKED

CHECKED

7

7

00-00-2006

00-00-1996

00-00-1999

00-00-1985

INTERMITTENT BACK SPASMS

<Row Deleted>

CHECKED

<Row Deleted>

CHECKED

<Row Deleted>

7

<Row Deleted>

7

<Row Deleted>

00-00-1996

<Row Deleted>

00-00-1999

<Row Deleted>

00-00-1985

<Row Deleted>

08-MAR-2010 11:22:15

04-DEC-2009 13:36:13

04-JAN-2010 16:08:08

11-FEB-2010 12:56:24

11-FEB-2010 12:56:24

04-DEC-2009 13:36:13

04-JAN-2010 16:08:08

11-FEB-2010 12:56:24

11-FEB-2010 12:56:24

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

04-DEC-2009 13:36:13

03-MAR-2010 12:40:42

09-MAR-2010 11:08:22

27-APR-2010 12:39:56

01-JUN-2010 14:39:05

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R259447413

Page_09

CD_001

R5020 Screening09


MH1

Date ofResolution

Date ofResolution

Date ofResolution

Date ofResolution

Date ofResolution

Date ofResolution

Date ofResolution

Diagnosis/Procedure

Diagnosis/Procedure

Diagnosis/Procedure

Diagnosis/Procedure

Diagnosis/Procedure

Diagnosis/Procedure

8

8

8

8

8

8

8

8

8

8

8

8

8

00-00-2006

BROKEN RIGHT TIBIA

POST MENOPAUSAL

INSOMNIA

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

POST MENOPAUSAL

<Row Deleted>

INSOMNIA

<Row Deleted>

SEASONAL ALLERGIES

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

04-DEC-2009 13:36:13

03-MAR-2010 12:40:42

09-MAR-2010 11:08:22

27-APR-2010 12:39:56

01-JUN-2010 14:39:05

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

04-DEC-2009 13:36:13

03-MAR-2010 12:40:42

09-MAR-2010 11:08:22

27-APR-2010 12:39:56

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R259447413

Page_09

CD_001

R5020 Screening09


MH1

Diagnosis/Procedure

Ongoing

Ongoing

Ongoing

Ongoing

Ongoing

Ongoing

Ongoing

Sequence Number

Sequence Number

Sequence Number

Sequence Number

Sequence Number

Sequence Number

Sequence Number

Date of Onset

8

8

8

8

8

8

8

8

8

8

8

8

8

8

8

9

SEASONAL ALLERGIES

CHECKED

CHECKED

CHECKED

8

8

8

8

00-00-2007

<Row Deleted>

<Row Deleted>

CHECKED

<Row Deleted>

CHECKED

<Row Deleted>

CHECKED

<Row Deleted>

<Row Deleted>

8

<Row Deleted>

8

<Row Deleted>

8

<Row Deleted>

<Row Deleted>

01-JUN-2010 14:39:05

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

04-DEC-2009 13:36:13

03-MAR-2010 12:40:42

09-MAR-2010 11:08:22

27-APR-2010 12:39:56

01-JUN-2010 14:39:05

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

04-DEC-2009 13:36:13

03-MAR-2010 12:40:42

09-MAR-2010 11:08:22

27-APR-2010 12:39:56

01-JUN-2010 14:39:05

04-DEC-2009 13:36:13

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

2

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R259447413

Page_09

CD_001

R5020 Screening09


MH1

Date ofResolution

Diagnosis/Procedure

Ongoing

Sequence Number

Date of Onset

Date ofResolution

Diagnosis/Procedure

Ongoing

Sequence Number

9

9

9

9

10

10

10

10

10

RECURRENT JOINT PAIN

CHECKED

9

00-00-1996

POST MENOPAUSAL

CHECKED

10

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

04-DEC-2009 13:36:13

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

22-OCT-2009 14:52:00

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

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


R259448313

Page_10

CD_001

R5020 Screening10

Smoking History Page number 10 Screening

DRUGSCR

Attempted toquit (Otherattempts) (5)

Attempted toquit(Pharmaceuticals) (3)

Comments (otherattemps) (7)

Comments(pharmaceuticals) (5)

If Yes, how many(pharmaceuticals) (4)

If yes, how many(other attemptsto quit (6)

1

1

1

1

1

1

YES

NO

AFTER HOSPITAL STAY

1

NO

YES

ATTEMPTED TWICE USINGWELLBUTRIN

2

10-NOV-2009 13:28:10

10-NOV-2009 13:28:10

10-NOV-2009 13:28:10

10-NOV-2009 13:28:10

10-NOV-2009 13:28:10

10-NOV-2009 13:28:10

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Data Entry Error

Data Entry Error

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


R259449713

Page_14

CD_001

R5020 Baseline, Week 014

Behavioral Coun Page number 14 Baseline, Week 0

EX1

Result

1 YES

23-JUL-2009 18:29:49

Sharon Ladenes

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R265106013

Page_16

CD_001

R5020 Sptp, Weeks 1-416

Status Review Page number 16 Sptp, Weeks 1-4

CHKYN

Comments(contacted byphone) (1)


Date

1

1

1

MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL.NO RETURN CALL RECEIVED

27-JUL-2009


ND

06-MAY-2010 13:01:26

06-MAY-2010 13:40:34

06-MAY-2010 13:01:26

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

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


R265106013

Page_16

CD_001


Status Review Page number 16.1 Sptp, Weeks 1-4

CHKYN



Date

1

1

1


03-AUG-2009


ND

06-MAY-2010 13:01:26

06-MAY-2010 13:40:34

06-MAY-2010 13:01:26

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

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


R265106013

Page_16

CD_001


Status Review Page number 16A Sptp, Weeks 1-4

CHKYN



Date

1

1

1


10-AUG-2009


ND

06-MAY-2010 13:01:26

06-MAY-2010 13:41:25

06-MAY-2010 13:01:26

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

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


R267031313

Page_17

CD_001

R5020 Ip, Week 617

Vs Page number 17 Ip, Week 6

VS

Diastolic BloodPressure

Systolic BloodPressure

1

1

90

123

UNK

UNK

10-FEB-2010 19:21:51

10-FEB-2010 19:21:51

Sharon Ladenes

Sharon Ladenes

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


R267031713

Page_18

CD_001

R5020 Ip, Week 618

Lb Page number 18 Ip, Week 6

LB

RequisitionNumber 1: (1)

Were there anyclinicallysignificant la(1)

1

1

NA

NO

20-OCT-2009 13:39:42

20-OCT-2009 13:39:42

Sharon Ladenes

Sharon Ladenes

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


R267032313

Page_20

CD_001

R5020 Ip, Week 620

Status Review Page number 20 Ip, Week 6

CHKYN

Comments(smoking statusreviewed) (2)1

SUBJECT STATES STILLSMOKING MOSTLY OUT OFHABIT. NOT SURE PRODUCTIS HELPING AS IT IS"AWAKWARD THAT IT'S INMY MOUTH"

22-OCT-2009 14:56:44

Sharon Ladenes

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R275376013

Page_21

CD_001

R5020 Ip, Week 821

CRF Header

DCI Blank Flag

1

Y

N

10-FEB-2010 19:22:56

Sharon Ladenes

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R275376013

Page_21

CD_001

R5020 Ip, Week 821

Status Review Page number 21 Ip, Week 8

CHKYN



Date

1

1

1

UNABLE TO CONTACT AFTER3 ATTEMPTS

14-SEP-2009

UNABLE TO CONTACT AFTER3 ATTEMPTS

ND

06-MAY-2010 13:08:16

06-MAY-2010 13:45:28

06-MAY-2010 13:08:16

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

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


R282982513

Page_27

CD_001

R5020 Ip, Week 1627

Lb Page number 27 Ip, Week 16

LB

Were there anyclinicallysignificant la(1)1

NO

10-FEB-2010 17:47:18

Sharon Ladenes

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R291331313

Page_36

CD_001

R5020 Fu, Week 2836

CRF Header

DCI Blank Flag

1

Y

N

02-FEB-2010 12:53:14

Sharon Ladenes

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R259450213

Page_39

CD_001

R5020 Pcm39

CRF Header

DCI Blank Flag

DCI Blank Flag

1

1

N

Y

Y

N

30-JUL-2009 16:38:07

03-SEP-2009 14:38:54

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R259450213

Page_39

CD_001

R5020 Pcm39

Pcm Page number 39 Pcm

CM1

Dose

Dose

Dose

Drug name

Drug name

Drug name

Frequency

Frequency

Frequency

Has the subjecttaken anymedications pr


Indication

Indication

Indication

1

1

1

1

1

1

1

1

1

1

1

1

1

1

600

UNKNOWN

IBUPROFEN

MIDOL

EVERY DAY

ONCE

NO

PAIN

MENSTRAL CRAMPS

UNKNOWN

600

2

MIDOL

IBUPROFEN

OMEGA 1+

ONCE

EVERY DAY

EVERY DAY

NO

YES

MENSTRAL CRAMPS

PAIN

SUPPLEMENT

23-JUL-2009 18:39:49

23-JUL-2009 18:54:57

04-JAN-2010 16:42:28

23-JUL-2009 18:39:49

23-JUL-2009 18:54:57

04-JAN-2010 16:42:28

23-JUL-2009 18:39:49

23-JUL-2009 18:54:57

04-JAN-2010 16:42:28

03-SEP-2009 14:38:54

04-JAN-2010 16:05:18

23-JUL-2009 18:39:49

23-JUL-2009 18:54:57

04-JAN-2010 16:42:28

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Data Entry Error

Data Entry Error

Row Inserted

CRA Correction

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Row Inserted

Data Entry Error

Data Entry Error

Data Entry Error

Row Inserted

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R259450213

Page_39

CD_001

R5020 Pcm39

Pcm Page number 39 Pcm

CM1

Ongoing

Start Date

Start Date

Start Date

Start Date

Stop Date

Stop Date

Stop Date

Unit

Unit

Unit

other, specify(frequency)

other, specify(unit)

1

1

1

1

1

1

1

1

1

1

1

1

1

00-00-1995

00-00-1999

07-JUL-2009

13-JUL-2009

07-JUL-2009

MILLIGRAMS

CHECKED

00-00-1999

07-JUL-2009

00-00-1999

00-00-2008

07-JUL-2009

13-JUL-2009

MILLIGRAMS

TABLET

04-JAN-2010 16:42:28

23-JUL-2009 18:35:11

23-JUL-2009 18:39:49

23-JUL-2009 18:54:57

04-JAN-2010 16:42:28

23-JUL-2009 18:39:49

23-JUL-2009 18:54:57

04-JAN-2010 16:42:28

23-JUL-2009 18:39:49

23-JUL-2009 18:54:57

04-JAN-2010 16:42:28

04-JAN-2010 16:42:28

04-JAN-2010 16:42:28

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Row Inserted

Data Entry Error

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Data Entry Error

Data Entry Error

Row Inserted

Row Inserted

Row Inserted

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R259450313

Page_39

CD_001

R5020 Pcm.1

CRF Header

DCI Blank Flag

DCI Blank Flag

1

1

N

Y

Y

N

30-JUL-2009 16:38:27

04-JAN-2010 16:43:31

Sharon Ladenes

Sharon Ladenes

Data Entry Error

CRA Correction

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R259450313

Page_39

CD_001

R5020 Pcm.1

Pcm Page number 39 Pcm.1

CM1

Dose

Drug name

Frequency


Indication

Ongoing

Start Date

Stop Date

Unit

other, specify(frequency)


1

1

1

1

1

1

1

1

1

1

1

1

MULTIVITAMIN

EVERY DAY

YES

SUPPLEMENT

CHECKED

00-00-1999

TABLET

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

04-JAN-2010 16:43:31

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R286407313

Page_39

CD_001

R5020 Pcm.3


CM1

Unit


1

1

MILLIGRAMS

OTHER

INTERNATIONAL UNITS

10-FEB-2010 19:29:58

10-FEB-2010 19:29:58

Sharon Ladenes

Sharon Ladenes

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


R286407413

Page_39

CD_001

R5020 Pcm.4


CM1

Dose

1

150

300

10-FEB-2010 18:03:30

Sharon Ladenes

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R286407613

Page_39

CD_001

R5020 Pcm.5


CM1

ATC1 Code

ATC1 Text

ATC2 Code

ATC2 Text

ATC3 Code

ATC3 Text

ATC4 Code

ATC4 Text

Dose

1

1

1

1

1

1

1

1

1

C

CARDIOVASCULAR SYSTEM, C

C01

CARDIAC THERAPY, C01

C01E

OTHER CARDIACPREPARATIONS, C01E

C01EB

OTHER CARDIACPREPARATIONS, C01EB

200

M

MUSCULO-SKELETAL SYSTEM,M

M01

ANTIINFLAMMATORY ANDANTIRHEUMATIC PRODUCTS,M01

M01A

ANTIINFLAMMATORY/ANTIRHEUMATIC PROD.,NON-STEROIDS, M01A

M01AE

PROPIONIC ACIDDERIVATIVES, M01AE

600

27-APR-2010 12:10:38

27-APR-2010 12:10:38

27-APR-2010 12:10:38

27-APR-2010 12:10:38

27-APR-2010 12:10:38

27-APR-2010 12:10:38

27-APR-2010 12:10:38

27-APR-2010 12:10:38

10-FEB-2010 18:04:37

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Sharon Ladenes

Class. Change

Class. Change

Class. Change

Class. Change

Class. Change

Class. Change

Class. Change

Class. Change

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R286407813

Page_39

CD_001

R5020 Pcm.6


CM1

ATC1 Code

ATC1 Text

ATC2 Code

ATC2 Text

ATC3 Code

ATC3 Text

Dose

Drug name

Indication

Indication

Indication

Preferred Term

Preferred TermCode

1

1

1

1

1

1

1

1

1

1

1

1

1

25

ALLERGY ANAHISTINE

SLEEPING

SLEEP AID

SLEEP AID IN RELATION TOSEASONAL ALLERGIES

R

RESPIRATORY SYSTEM, R

R06

ANTIHISTAMINES FORSYSTEMIC USE, R06

R06A

ANTIHISTAMINES FORSYSTEMIC USE, R06A

50

ALLERGY ANTIHISTAMINE

SLEEP AID

SLEEP AID IN RELATION TOSEASONAL ALLERGIES

SLEEP AID

ANTIHISTAMINES

90047901001

26-APR-2010 10:36:00

26-APR-2010 10:36:00

26-APR-2010 10:36:00

26-APR-2010 10:36:00

26-APR-2010 10:36:00

26-APR-2010 10:36:00

10-FEB-2010 19:31:02

08-MAR-2010 16:21:05

11-FEB-2010 13:01:33

27-APR-2010 11:56:14

01-JUN-2010 14:40:31

26-APR-2010 10:36:00

26-APR-2010 10:36:00

Carol Kraucyk

Carol Kraucyk

Carol Kraucyk

Carol Kraucyk

Carol Kraucyk

Carol Kraucyk

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Carol Kraucyk

Carol Kraucyk

Class. Change

Class. Change

Class. Change

Class. Change

Class. Change

Class. Change

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Data Entry Error

Class. Change

Class. Change

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R286408013

Page_39

CD_001

R5020 Pcm.7


CM1

Indication

Ongoing

Stop Date

Stop Date

Stop Date

1

1

1

1

1

BACK SPASMS

CHECKED

UNK

30-SEP-2009

PRE-EXISTING BACK SPASMSINTERMITTENT

UNK

30-SEP-2009

11-SEP-2009

04-MAR-2010 14:39:39

04-FEB-2010 17:59:26

04-FEB-2010 17:59:26

04-MAR-2010 14:39:39

08-MAR-2010 11:25:03

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

SUBJECT REPORTSEXACT DAY UNKNOWN,HOWEVER IT WASONLY A 30 DAYSUPPLY

Data Entry Error

Data Entry Error

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


R272840913

Page_40

CD_001

R5020 Ae40

CRF Header

DCI Blank Flag

DCI Blank Flag

1

1

N

Y

Y

N

10-NOV-2009 18:50:44

02-FEB-2010 14:07:14

Sharon Ladenes

Sharon Ladenes

Key Change

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R282982213

Page_43

CD_001

R5020 Additional Vs43

Vs Page number 43 Additional Vs

VS

Body Temperature

Heart Rate

Respiratory Rate

1

1

1

NA

NA

NA

ND

ND

ND

25-FEB-2010 12:12:32

25-FEB-2010 12:12:32

25-FEB-2010 12:12:32

Sharon Ladenes

Sharon Ladenes

Sharon Ladenes

Validation Statuschanged



1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R259337813

CD_001

CD_001

R5020

R5020

1789641613

20543911

SCREENING

SCREENING

IC

IC

2

2

PAGE_02

PAGE_02

Inclusion Criteria Answer 6

CURRENT

CURRENT

Data value changed. Disc no longer applicable.

Confirmed

MANUAL

MULTIVARIATE

Resolved-Response Edited


NO

Waiver granted for subject not having regular dental check-ups. Please revise responseto question.

Response to Inclusion Criterion <06> is No. Please verify response and ensure subjecteligibility page is completed as appropriate.

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:


R259352813

CD_001 R50201789641713

SCREENING

EC 3PAGE_03

Exclusion Criteria Answer 3

CURRENT


MANUAL


NO

Please verify if this questions should be answered No see query for inclusion #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:


R259445213

CD_001 R50201789641813

SCREENING

ELIG 4PAGE_04

Category 1

CURRENT


MANUAL


I

Please verify if this should be 'I' number 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:


R259447413

CD_001 R502081724111

SCREENING

MH 9PAGE_09

Diagnosis/Procedure 5

CURRENT


MANUAL


OVARIAN CYST (RIGHT OVARY)

Per source this is the right ovary. Please review source and amend CRF page ifapplicable.

Updated CRF, verified 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:


R265106013

CD_001 R5020115220811

SPTP, WEEKS 1-4

STATUS REVIEW 16PAGE_16

Date 1

CURRENT


MANUAL


ND

Please update date to 'ND' as assessment did not occur.

DM Response: Please replace the comment that was previously present (MESSAGE WAS LEFT FORSUBJECT TO RETURN CALL. NO RETURN CALL RECEIVED).

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:


R265106013

CD_001 R5020115220911

SPTP, WEEKS 1-4

STATUS REVIEW 16.1PAGE_16

Date 1

CURRENT


MANUAL


ND



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:


R265106013

CD_001 R5020115221011

SPTP, WEEKS 1-4

STATUS REVIEW 16APAGE_16

Date 1

CURRENT


MANUAL


ND



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:


R267031313

CD_001 R502060985311

IP, WEEK 6

VS 17PAGE_17

Systolic Blood Pressure 1

CURRENT


MANUAL


UNK

Please review footnotes regarding the systolic /diastolic at this visit. Amend CRF pageif 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:


R275376013

CD_001

CD_001

R5020

R5020

115222211

60986211

IP, WEEK 8

IP, WEEK 8

STATUS REVIEW

STATUS REVIEW

21

21

PAGE_21

PAGE_21

Date 1

CURRENT

CURRENT



MANUAL

MANUAL HEADER



ND


Please review source. Please add the date of the visit, check no to the first questionand enter comment from source unable to contact subject after 3 attempts.

DM Response: A comment was previously present 'Unable to contact after 3 attempts'.Please replace comment.

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:


R282982513

CD_001 R502061027711

IP, WEEK 16

LB 27PAGE_27

Were there any clinically significant la 1

CURRENT


MANUAL


NO

Please answer question.

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:


R286407313

CD_001 R502061028411

PCM.3

PCM 39PAGE_39

Unit 1

CURRENT


MANUAL


OTHER

Please clarify the units, source shows international units. Please review source,clarify and amend CRF page 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:


R286407413

CD_001 R502061028611

PCM.4

PCM 39PAGE_39

Dose 1

CURRENT


MANUAL


300

Please see source for correct amount. Per source, 150 mg capsules that the subject takes2 capsules (300mg) everyday. Please review and amend CRF page 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:


R286407613

CD_001 R502061028711

PCM.5

PCM 39PAGE_39

Dose 1

CURRENT


MANUAL


600

Please review source for amount taken, 200 mg soft gels which the subject takes 3 softgels QD. Please review and amend CRF 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:


R286407813

CD_001

CD_001

CD_001

R5020

R5020

R5020

61029011

79784811

60899211

PCM.6

PCM.6

PCM.6

PCM

PCM

PCM

39

39

39

PAGE_39

PAGE_39

PAGE_39

Dose

Drug name

Indication

1

1

1

CURRENT

CURRENT

CURRENT




MANUAL

MANUAL

MANUAL




50

ALLERGY ANTIHISTAMINE

SLEEP AID

Please review amount taken by subject.

Please verify spelling of antihistamine.

Per monitor, please amend indication to sleep aid.

confirmed

Document #:

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:


R286407813

CD_001

CD_001

R5020

R5020

98559511

104319811

PCM.6

PCM.6

PCM

PCM

39

39

PAGE_39

PAGE_39

CURRENT

CURRENT

Confirmed

Confirmed

MANUAL HEADER

MANUAL HEADER



Please verify indication of sleep aid. If correct, please provide reason andcorresponding medical history.

Please update indication to indicate that it is a sleep aid in relation to seasonalallergies.

Seasonal allergies prevent subject from sleeping

Please also add Seasonal allergies to Medical history. - PLEASE ADD DONE

Verified. JLM 20Apr2010

Verified. JLM 27Apr2010

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:


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