crf report for study e7694105 · 2014. 8. 22. · crf report for study e7694105 report run by brian...
TRANSCRIPT
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
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
11.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
13.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
20.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
25.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
26.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
27.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
28.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
29.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
30.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
32.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
39.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
40.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
42.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
43.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
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
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
45.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
Appendix: Audit and Discrepancy Information
Report run by Brian Saari at 05-MAR-2013 09:29:33 68Page
Report run by Brian Saari at 05-MAR-2013 09:29:33 69Page
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.
Report run by Brian Saari at 05-MAR-2013 09:29:33 70Page
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
Report run by Brian Saari at 05-MAR-2013 09:29:33 71Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 72Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 73Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 74Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 75Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 76Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 77Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 78Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 79Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 80Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 81Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 82Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 83Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 84Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 85Page
R278147913
Page_42
P3880_0342
R4022 Additional Lab42
Lb Page number 42 Additional Lab
LB
ClinicallySignificant(additional) (2)
ClinicallySignificant(additional) (2)
Comments
Date
RequisitionNumber(additionallabs) (4)
Test Code ID CSLabs only
Test Name CSLabs only
Were anyadditionalLaboratoryevaluatio
ClinicallySignificant(additional) (2)
ClinicallySignificant(additional) (2)
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 86Page
R278147913
Page_42
P3880_0342
R4022 Additional Lab42
Lb Page number 42 Additional Lab
LB
ClinicallySignificant(additional) (2)
Comments
Comments
Date
Date
RequisitionNumber(additionallabs) (4)
RequisitionNumber(additionallabs) (4)
Test Code ID CSLabs only
Test Code ID CSLabs only
Test Name CSLabs only
Test Name CSLabs only
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 05-MAR-2013 09:29:33 87Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 88Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
Report run by Brian Saari at 05-MAR-2013 09:29:33 89Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 90Page
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
Qualifying Prompt Qualifying Value Section Visit
Group # Group Name
FieldRow
Changed From
Changed ToImpact onresequence
OnBy
Reason
Comment
Report run by Brian Saari at 05-MAR-2013 09:29:33 91Page
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:
Report run by Brian Saari at 05-MAR-2013 09:29:33 92Page
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
Data value changed. Disc no longer applicable.
MANUAL
MANUAL
MANUAL HEADER
Resolved-Response Edited
Resolved-Response Edited
Resolved-Response Edited
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:
Report run by Brian Saari at 05-MAR-2013 09:29:33 93Page
R278137413
P3880_0342 R402233384411
SCREENING
MH 9PAGE_09
Date of Onset 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
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:
Report run by Brian Saari at 05-MAR-2013 09:29:33 94Page
R247048513
P3880_0342 R40221730992913
IP, WEEK 6
STATUS REVIEW 20PAGE_20
If Subject was not compliant, approximat 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
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:
Report run by Brian Saari at 05-MAR-2013 09:29:33 95Page
R278140913
P3880_0342 R402233385411
IP, WEEK 13
STATUS REVIEW 25PAGE_25
If Subject was not compliant, approximat 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
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:
Report run by Brian Saari at 05-MAR-2013 09:29:33 96Page
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
Resolved-Response Edited
Resolved-Response Edited
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
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Report run by Brian Saari at 05-MAR-2013 09:29:33 97Page
R278148213
P3880_0342 R402290240111
ADDITIONAL PE
PE 44PAGE_44
Findings 1
CURRENT
No Action Required
MANUAL
Resolved-Response Edited
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.
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Report run by Brian Saari at 05-MAR-2013 09:29:33 98Page
Deleted CRFs Report