crf report for study e7694105 · 2014. 8. 22. · crf report for study e7694105 report run by brian...

CRF Report for Study E7694105Report run by Brian Saari at 05-MAR-2013 09:29:29

Abc 123

Abc 123

P3880_0342

All statuses

All statuses

R4022

R4022

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

09.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

10.LINKS



11.LINKS




13.LINKS




20.LINKS




25.LINKS




26.LINKS



27.LINKS



28.LINKS



29.LINKS



30.LINKS



32.LINKS



39.LINKS




40.LINKS



42.LINKS



43.LINKS



44.OS.1

OverFlow Section For Document Number R278148213

GREAT TOE NAILS 1/2 GROWN IN "HAD FALLEN OFF AFTER RUNNING AND FUNGUS", NAILSGROWING BACK OKAY

1

44.LINKS




45.LINKS



Appendix: Audit and Discrepancy Information

Report run by Brian Saari at 05-MAR-2013 09:29:33 68Page


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.


R278137413

Page_09

P3880_0342

R4022 Screening09

Mh Page number 9 Screening

MH1

Date of Onset

1

25-MAY-2009

00-MAY-2008

02-FEB-2010 11:30:00

Lana Glaser

Data Entry Error

2

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


R247046413

Page_10

P3880_0342

R4022 Screening10

Smoking History Page number 10 Screening

DRUGSCR

Comments (otherattemps) (7)1

UNKNOWN

06-NOV-2009 11:32:59

Kim Freschly

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R247046813

Page_11

P3880_0342

R4022 Screening11

Oral Health Exam Page number 11 Screening

EX1

Findings*

3

NE

NO

19-JUN-2009 13:33:33

Kim Freschly

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R247047013

Page_13

P3880_0342

R4022 Screening13

Behavioral Coun Page number 13 Screening

EX1

Comments

Date

Date

Date

Result

2

2

2

2

2

26-MAR-2009

30-MAR-2009

ND

YES

NOT GIVEN AT SCREENING

30-MAR-2009

ND

26-MAR-2009

NO

18-MAR-2010 16:42:29

06-NOV-2009 11:33:41

18-MAR-2010 16:42:29

12-MAY-2010 13:43:39

18-MAR-2010 16:42:29

Lana Glaser

Kim Freschly

Lana Glaser

Lana Glaser

Lana Glaser

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


R247048513

Page_20

P3880_0342

R4022 Ip, Week 620

Status Review Page number 20 Ip, Week 6

CHKYN

If Subject wasnot compliant,approximat (5)1

14

7

06-NOV-2009 11:34:35

Kim Freschly

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278140913

Page_25

P3880_0342

R4022 Ip, Week 1325

Status Review Page number 25 Ip, Week 13

CHKYN

If Subject wasnot compliant,approximat (5)1

14

2

04-JAN-2010 11:33:33

Kim Freschly

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278141313

Page_26

P3880_0342

R4022 Ip, Week 1626

CRF Header

DCI Blank Flag

1

N

Y

19-MAR-2010 08:13:02

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278142413

Page_27

P3880_0342

R4022 Ip, Week 1627

CRF Header

DCI Blank Flag

1

N

Y

19-MAR-2010 08:13:22

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278142913

Page_28

P3880_0342

R4022 Ip, Week 1628

CRF Header

DCI Blank Flag

1

N

Y

19-MAR-2010 08:13:28

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278143013

Page_29

P3880_0342

R4022 Ip, Week 1629

CRF Header

DCI Blank Flag

1

N

Y

19-MAR-2010 08:13:35

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278143413

Page_30

P3880_0342

R4022 Ip, Week 1630

CRF Header

DCI Blank Flag

1

N

Y

19-MAR-2010 08:13:55

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278144313

Page_32

P3880_0342

R4022 Fu, Week 20 & 2432

CRF Header

DCI Blank Flag

1

N

Y

18-MAR-2010 17:35:15

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278144313

Page_32

P3880_0342

R4022 Fu, Week 20 & 2432

Status Review Page number 32.1 Fu, Week 20 & 24

CHKYN

Was Subjectcontacted bytelephone (1)

Was Subjectcontacted bytelephone (1)

1

1

NO

NO

06-NOV-2009 11:39:23

04-JAN-2010 11:34:14

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


R278145613

Page_39

P3880_0342

R4022 Pcm39

Pcm Page number 39 Pcm

CM1

ATC1 Code

ATC1 Text

ATC2 Code

ATC2 Text

ATC3 Code

ATC3 Text

ATC4 Code

ATC4 Text

Frequency

Ongoing

Stop Date

Stop Date

Stop Date

1

1

1

1

1

1

1

1

1

1

1

1

1

D

DERMATOLOGICALS, D

D01

ANTIFUNGALS FORDERMATOLOGICAL USE, D01

D01A

ANTIFUNGALS FOR TOPICALUSE, D01A

D01AC

IMIDAZOLE AND TRIAZOLEDERIVATIVES, D01AC

EVERY WEEK

CHECKED

UNK

00-MAY-2009

J

ANTIINFECTIVES FORSYSTEMIC USE, J

J02

ANTIMYCOTICS FORSYSTEMIC USE, J02

J02A

ANTIMYCOTICS FORSYSTEMIC USE, J02A

J02AC

TRIAZOLE DERIVATIVES,J02AC

ONCE

UNK

00-MAY-2009

25-MAY-2009

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

13-APR-2010 12:52:26

04-JAN-2010 11:35:26

04-JAN-2010 11:35:26

02-FEB-2010 11:32:29

02-FEB-2010 11:34:12

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Joanne Mccaigue

Lana Glaser

Kim Freschly

Kim Freschly

Lana Glaser

Lana Glaser

Class. Change

Class. Change

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

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R296687413

Page_40

P3880_0342

R4022 Ae40

Ae Page number 40 Ae

CRF

Document

1

R278146113

<CRF Deleted>

03-MAR-2010 13:38:27

Kim Freschly

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278147913

Page_42

P3880_0342

R4022 Additional Lab42

Lb Page number 42 Additional Lab

LB

ClinicallySignificant(additional) (2)


Comments

Date

RequisitionNumber(additionallabs) (4)

Test Code ID CSLabs only

Test Name CSLabs only

Were anyadditionalLaboratoryevaluatio



1

1

1

1

1

1

1

1

2

2

NO

YES

NO

18-AUG-2009

NA

YES

YES

19-MAR-2010 08:14:11

19-MAR-2010 08:14:34

19-MAR-2010 08:14:11

19-MAR-2010 08:14:11

19-MAR-2010 08:14:11

19-MAR-2010 08:14:11

19-MAR-2010 08:14:11

19-MAR-2010 08:14:11

19-MAR-2010 08:14:11

19-MAR-2010 08:14:34

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Row Inserted

Data Entry Error

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Row Inserted

Data Entry Error

Row Inserted

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278147913

Page_42

P3880_0342

R4022 Additional Lab42

Lb Page number 42 Additional Lab

LB


Comments

Comments

Date

Date







2

2

2

2

2

2

2

2

2

2

2

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

<Row Deleted>

19-MAR-2010 08:14:42

19-MAR-2010 08:14:11

19-MAR-2010 08:14:42

19-MAR-2010 08:14:11

19-MAR-2010 08:14:42

19-MAR-2010 08:14:11

19-MAR-2010 08:14:42

19-MAR-2010 08:14:11

19-MAR-2010 08:14:42

19-MAR-2010 08:14:11

19-MAR-2010 08:14:42

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

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

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R278148113

Page_43

P3880_0342

R4022 Additional Vs43

Vs Page number 43 Additional Vs

VS

Actual Time

Body Temperature

Body TemperatureUnit

Comments (2)

Date

Diastolic BloodPressure

Diastolic BloodPressure unit

Heart Rate

Heart Rate Unit

Other, specify(1)

Position(Unscheduled)(2)

Respiratory Rate

Respiratory RateUnit

1

1

1

1

1

1

1

1

1

1

1

1

1

1638

37.0

C

18-AUG-2009

70

MMHG

86

BEATS/MINUTE

SEATED

16

BREATHS/MINUTE

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Lana Glaser

Row Inserted

Row Inserted

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


R278148113

Page_43

P3880_0342

R4022 Additional Vs43

Vs Page number 43 Additional Vs

VS

Systolic BloodPressure

Systolic BloodPressure unit

Were Vital SignsCollected/Wereany addi (1)

1

1

1

NO

105

MMHG

YES

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

19-MAR-2010 08:14:53

Lana Glaser

Lana Glaser

Lana Glaser

Row Inserted

Row Inserted

Data Entry Error

1

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name


R278148213

Page_44

P3880_0342

R4022 Additional Pe44

CRF Header

DCI Blank Flag

1

Y

N

19-MAR-2010 08:15:28

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R278148313

Page_45

P3880_0342

R4022 Oral Health Exam45

CRF Header

DCI Blank Flag

1

Y

N

19-MAR-2010 08:16:56

Lana Glaser

Data Entry Error

0

Document #:

PatientSite

Visit

Visit Date

CRFCRF Page

SectionSection Date


Group # Group Name

FieldRow

Changed From


OnBy

Reason

Comment


R247046813

P3880_0342 R40221672764213

SCREENING

ORAL HEALTH EXA 11PAGE_11

Findings* 3

CURRENT

Confirmed

MANUAL

Resolved-Response Edited

NO

Please update to 'No' per CRF guidelines

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:


R247047013

P3880_0342

P3880_0342

P3880_0342

R4022

R4022

R4022

86823511

1730992313

119606611

SCREENING

SCREENING

SCREENING

BEHAVIORAL COUN

BEHAVIORAL COUN

BEHAVIORAL COUN

13

13

13

PAGE_13

PAGE_13

PAGE_13

Date

Result

2

2

CURRENT

CURRENT

CURRENT

Data value changed. Disc no longer applicable.

Confirmed


MANUAL

MANUAL

MANUAL HEADER




20090326

NO

Screening assessmemts occurred on 26-Mar-2009. Please enter correct date. If booklet wasnot given at Screening, please check No and enter a comment.

Please verify. Source is not signed for dispensing of clean air booklet

Due to setup, ND can not be entered. Please add the date (26Mar2009).

comment added

Source correction requested.

added

RECEIVED BOOKLET AT FIRST VISIT

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:


R278137413

P3880_0342 R402233384411

SCREENING

MH 9PAGE_09

Date of Onset 1

CURRENT


MANUAL


200805

Please review - start date is after study start.

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:


R247048513

P3880_0342 R40221730992913

IP, WEEK 6

STATUS REVIEW 20PAGE_20

If Subject was not compliant, approximat 1

CURRENT

Confirmed

MANUAL


7

Please review # smoked - use information from week 6 diary ( week ending 5/14/09

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:


R278140913

P3880_0342 R402233385411

IP, WEEK 13

STATUS REVIEW 25PAGE_25

If Subject was not compliant, approximat 1

CURRENT

Confirmed

MANUAL


2

Please review value. Per source 4 cigs/2 weeks = 2/week

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:


R278145613

P3880_0342

P3880_0342

R4022

R4022

99016711

33390911

PCM

PCM

PCM

PCM

39

39

PAGE_39

PAGE_39

Frequency

Stop Date

1

1

CURRENT

CURRENT

Confirmed

Confirmed

MANUAL

MANUAL



ONCE

20090525

Please verify frequency...medication was only taken for one day.

Please review for stop date

Please review if freq is 1 - source indicates 1 per week...

Verified. JLM 20Apr2010

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:


R278148213

P3880_0342 R402290240111

ADDITIONAL PE

PE 44PAGE_44

Findings 1

CURRENT

No Action Required

MANUAL


GREAT TOE NAILS 1/2 GROWN IN "HAD FALLEN OFF AFTER RUNNING AND FUNGUS", NAILS GROWINGBACK OKAY

Physical exam finding is recorded after first product administration. Please record acorresponding event on the adverse events page.

this is not an AE as subject had condition at screening.

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 e7694105 · 2014. 8. 22. · crf report for study e7694105 report run by brian...

Documents