The Factors Influencing the Food Choice and Nutritional Status of Elderly People Living Freely on
CRF Report for Study E7694105 · 2014. 8. 22. · R2025 R2025 All statuses Report Parameters Abc...
101
CRF Report for Study E7694105 Report run by Brian Saari at 05-MAR-2013 15:50:45 Abc 123 Abc 123 L0689282_2 All statuses All statuses R2025 R2025 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: Prompt Data value Data value with discrepancy
Transcript of CRF Report for Study E7694105 · 2014. 8. 22. · R2025 R2025 All statuses Report Parameters Abc...
CRF Report for Study E7694105Report run by Brian Saari at 05-MAR-2013 15:50:45
Abc 123
Abc 123
L0689282_2
All statuses
All statuses
R2025
R2025
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
06.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to discrepancy details for this CRF
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
14.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
17.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
24.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
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
39.1.U1.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
39.1.U2.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
39.1.U3.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
39.1.U4.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
39.1.U5.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
39.1.U6.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
39.1.U7.LINKS
Links to Discrepancy and Audit Sections
Click here to navigate to audit history for this CRF
40.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 15:50:49 71Page
Report run by Brian Saari at 05-MAR-2013 15:50:49 72Page
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 15:50:49 73Page
R264454113
Page_09
L0689282_2
R2025 Screening09
Mh Page number 9 Screening
DTE
MH1
Date
Date of Onset
Date ofResolution
Diagnosis/Procedure
Ongoing
Sequence Number
Date of Onset
Date ofResolution
Diagnosis/Procedure
Ongoing
Sequence Number
Date of Onset
1
2
2
2
2
2
3
3
3
3
3
4
26-JUN-2009
29-JUN-2009
00-00-1994
TENSION HEADACHES
CHECKED
02
00-00-1995
GENERAL ACHES AND PAIN
CHECKED
03
11-JUL-2009
26-FEB-2010 15:22:06
12-APR-2010 12:37:24
12-APR-2010 12:37:24
12-APR-2010 12:37:24
12-APR-2010 12:37:24
12-APR-2010 12:37:24
14-APR-2010 16:41:21
14-APR-2010 16:41:21
14-APR-2010 16:41:21
14-APR-2010 16:41:21
14-APR-2010 16:41:21
20-APR-2010 14:29:10
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Data Entry Error
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
Row Inserted
1
2
Document #:
PatientSite
Visit
Visit Date
CRFCRF Page
SectionSection Date
Qualifying Prompt Qualifying Value Section Visit
Group #
Group #
Group Name
Group Name
Field
Field
Row
Row
Changed From
Changed From
Changed To
Changed To
Impact onresequence
Impact onresequence
On
On
By
By
Reason
Reason
Comment
Comment
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R264454113
Page_09
L0689282_2
R2025 Screening09
Mh Page number 9 Screening
MH1
Date ofResolution
Diagnosis/Procedure
Ongoing
Sequence Number
4
4
4
4
17-JUL-2009
POISON IVY RASH
04
20-APR-2010 14:29:10
20-APR-2010 14:29:10
20-APR-2010 14:29:10
20-APR-2010 14:29:10
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
Row Inserted
Row Inserted
Row Inserted
Row Inserted
2
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 15:50:49 75Page
R264455513
Page_14
L0689282_2
R2025 Baseline, Week 014
Eco Page number 14 Baseline, Week 0
EX1
%COHb
Actual Time
Date
ECO Level
1
1
1
1
2.8
1212
09-JUL-2009
14
3.0
1311
13-JUL-2009
15
17-AUG-2009 15:20:55
17-AUG-2009 15:20:55
17-AUG-2009 15:20:55
17-AUG-2009 15:20:55
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
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
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R264455513
Page_14
L0689282_2
R2025 Baseline, Week 014
Behavioral Coun Page number 14 Baseline, Week 0
EX1
Date
1
09-JUL-2009
13-JUL-2009
17-AUG-2009 15:20:55
Amanda Lynn
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 15:50:49 77Page
R264455513
Page_14
L0689282_2
R2025 Baseline, Week 014
Questionnaires Page number 14 Baseline, Week 0
EX1
Date
1
09-JUL-2009
13-JUL-2009
02-SEP-2009 12:23:34
Amanda Lynn
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
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R266288013
Page_17
L0689282_2
R2025 Ip, Week 617
Vs Page number 17 Ip, Week 6
VS
Respiratory Rate
1
8
18
02-SEP-2009 12:24:29
Amanda Lynn
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 15:50:49 79Page
R266288413
Page_20
L0689282_2
R2025 Ip, Week 620
Status Review Page number 20 Ip, Week 6
CHKYN
If Subject wasnot compliant,approximat (5)1
20
7
23-OCT-2009 10:33:43
Cindy Riojas Prakop
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 15:50:49 80Page
R271133413
Page_24
L0689282_2
R2025 Ip, Week 1024
Status Review Page number 24 Ip, Week 10
CHKYN
If Subject wasnot compliant,approximat (5)1
14
UNK
16-FEB-2010 14:54:13
Amanda Lynn
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
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R264457013
Page_39
L0689282_2
R2025 Pcm39
Pcm Page number 39 Pcm
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
1
1
1
1
1
1
1
1
A
ALIMENTARY TRACT ANDMETABOLISM, A
A01
STOMATOLOGICALPREPARATIONS, A01
A01A
STOMATOLOGICALPREPARATIONS, A01A
A01AD
OTHER AGENTS FOR LOCALORAL TREATMENT, A01AD
N
NERVOUS SYSTEM, N
N02
ANALGESICS, N02
N02B
OTHER ANALGESICS ANDANTIPYRETICS, N02B
N02BA
SALICYLIC ACID ANDDERIVATIVES, N02BA
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
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
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
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R264457313
Page_39
L0689282_2
R2025 Pcm.1
Pcm Page number 39 Pcm.1
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
1
1
1
1
1
1
1
1
C
CARDIOVASCULAR SYSTEM, C
C01
CARDIAC THERAPY, C01
C01E
OTHER CARDIACPREPARATIONS, C01E
C01EB
OTHER CARDIACPREPARATIONS, C01EB
M
MUSCULO-SKELETAL SYSTEM,M
M01
ANTIINFLAMMATORY ANDANTIRHEUMATIC PRODUCTS,M01
M01A
ANTIINFLAMMATORY/ANTIRHEUMATIC PROD.,NON-STEROIDS, M01A
M01AE
PROPIONIC ACIDDERIVATIVES, M01AE
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
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
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
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R264457613
Page_39
L0689282_2
R2025 Pcm.2
Pcm Page number 39 Pcm.2
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
Dose
Frequency
Stop Date
Unit
1
1
1
1
1
1
1
1
1
1
1
1
A
ALIMENTARY TRACT ANDMETABOLISM, A
A07
ANTIDIARR.,INTEST.ANTIINFL./ANTIINFECT.AGENTS, A07
A07E
INTESTINALANTIINFLAMMATORY AGENTS,A07E
A07EA
CORTICOSTEROIDS ACTINGLOCALLY, A07EA
4
MILLIGRAMS
H
SYSTEMIC HORMONALPREP.,EXCL.SEX HORM.ANDINSULIN, H
H02
CORTICOSTEROIDS FORSYSTEMIC USE, H02
H02A
CORTICOSTEROIDS FORSYSTEMIC USE, PLAIN,H02A
H02AB
GLUCOCORTICOIDS, H02AB
6
ONCE
14-JUL-2009
TABLET
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
02-SEP-2009 12:50:53
02-SEP-2009 12:50:53
02-SEP-2009 12:50:53
02-SEP-2009 12:50:53
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Amanda Lynn
Amanda Lynn
Amanda Lynn
Amanda Lynn
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
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 15:50:49 84Page
R266794113
Page_39
L0689282_2
R2025 Pcm.3
Pcm Page number 39 Pcm.3
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
Indication
1
1
1
1
1
1
1
1
1
A
ALIMENTARY TRACT ANDMETABOLISM, A
A07
ANTIDIARR.,INTEST.ANTIINFL./ANTIINFECT.AGENTS, A07
A07E
INTESTINALANTIINFLAMMATORY AGENTS,A07E
A07EA
CORTICOSTEROIDS ACTINGLOCALLY, A07EA
POSION IVY
H
SYSTEMIC HORMONALPREP.,EXCL.SEX HORM.ANDINSULIN, H
H02
CORTICOSTEROIDS FORSYSTEMIC USE, H02
H02A
CORTICOSTEROIDS FORSYSTEMIC USE, PLAIN,H02A
H02AB
GLUCOCORTICOIDS, H02AB
POISON IVY
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
09-APR-2010 15:14:30
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue Obvious spellingcorrection. JLM09Apr2010
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
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
Report run by Brian Saari at 05-MAR-2013 15:50:49 85Page
R266794213
Page_39
L0689282_2
R2025 Pcm.4
Pcm Page number 39 Pcm.4
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
Drug name
Indication
1
1
1
1
1
1
1
1
1
1
A
ALIMENTARY TRACT ANDMETABOLISM, A
A07
ANTIDIARR.,INTEST.ANTIINFL./ANTIINFECT.AGENTS, A07
A07E
INTESTINALANTIINFLAMMATORY AGENTS,A07E
A07EA
CORTICOSTEROIDS ACTINGLOCALLY, A07EA
PREDNISON
POISION IVY
H
SYSTEMIC HORMONALPREP.,EXCL.SEX HORM.ANDINSULIN, H
H02
CORTICOSTEROIDS FORSYSTEMIC USE, H02
H02A
CORTICOSTEROIDS FORSYSTEMIC USE, PLAIN,H02A
H02AB
GLUCOCORTICOIDS, H02AB
PREDNISONE
POISON IVY
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
02-SEP-2009 12:57:03
09-APR-2010 15:15:01
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Amanda Lynn
Joanne Mccaigue Obvious spellingcorrection. JLM09Apr2010
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Data Entry Error
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
Report run by Brian Saari at 05-MAR-2013 15:50:49 86Page
R266794313
Page_39
L0689282_2
R2025 Pcm.5
Pcm Page number 39 Pcm.5
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
Indication
1
1
1
1
1
1
1
1
1
A
ALIMENTARY TRACT ANDMETABOLISM, A
A07
ANTIDIARR.,INTEST.ANTIINFL./ANTIINFECT.AGENTS, A07
A07E
INTESTINALANTIINFLAMMATORY AGENTS,A07E
A07EA
CORTICOSTEROIDS ACTINGLOCALLY, A07EA
POISION IVY
H
SYSTEMIC HORMONALPREP.,EXCL.SEX HORM.ANDINSULIN, H
H02
CORTICOSTEROIDS FORSYSTEMIC USE, H02
H02A
CORTICOSTEROIDS FORSYSTEMIC USE, PLAIN,H02A
H02AB
GLUCOCORTICOIDS, H02AB
POISON IVY
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
09-APR-2010 15:15:10
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue Obvious spellingcorrection. JLM09Apr2010
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
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
Report run by Brian Saari at 05-MAR-2013 15:50:49 87Page
R266794413
Page_39
L0689282_2
R2025 Pcm.6
Pcm Page number 39 Pcm.6
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
Indication
1
1
1
1
1
1
1
1
1
A
ALIMENTARY TRACT ANDMETABOLISM, A
A07
ANTIDIARR.,INTEST.ANTIINFL./ANTIINFECT.AGENTS, A07
A07E
INTESTINALANTIINFLAMMATORY AGENTS,A07E
A07EA
CORTICOSTEROIDS ACTINGLOCALLY, A07EA
POISION IVY
H
SYSTEMIC HORMONALPREP.,EXCL.SEX HORM.ANDINSULIN, H
H02
CORTICOSTEROIDS FORSYSTEMIC USE, H02
H02A
CORTICOSTEROIDS FORSYSTEMIC USE, PLAIN,H02A
H02AB
GLUCOCORTICOIDS, H02AB
POISON IVY
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
09-APR-2010 15:15:20
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue Obvious spellingcorrection. JLM09Apr2010
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
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
Report run by Brian Saari at 05-MAR-2013 15:50:49 88Page
R266794513
Page_39
L0689282_2
R2025 Pcm.7
Pcm Page number 39 Pcm.7
CM1
ATC1 Code
ATC1 Text
ATC2 Code
ATC2 Text
ATC3 Code
ATC3 Text
ATC4 Code
ATC4 Text
Indication
1
1
1
1
1
1
1
1
1
A
ALIMENTARY TRACT ANDMETABOLISM, A
A07
ANTIDIARR.,INTEST.ANTIINFL./ANTIINFECT.AGENTS, A07
A07E
INTESTINALANTIINFLAMMATORY AGENTS,A07E
A07EA
CORTICOSTEROIDS ACTINGLOCALLY, A07EA
POISION IVY
H
SYSTEMIC HORMONALPREP.,EXCL.SEX HORM.ANDINSULIN, H
H02
CORTICOSTEROIDS FORSYSTEMIC USE, H02
H02A
CORTICOSTEROIDS FORSYSTEMIC USE, PLAIN,H02A
H02AB
GLUCOCORTICOIDS, H02AB
POISON IVY
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
09-APR-2010 15:15:28
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue
Joanne Mccaigue Obvious spellingcorrection. JLM09Apr2010
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
Class. Change
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
Report run by Brian Saari at 05-MAR-2013 15:50:49 89Page
R264458613
Page_40
L0689282_2
R2025 Ae40
CRF Header
DCI Blank Flag
DCI Blank Flag
1
1
N
Y
Y
N
20-APR-2010 14:28:47
21-APR-2010 12:59:41
Amanda Lynn
Amanda Lynn
Data Entry Error
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 15:50:49 90Page
R264458613
Page_40
L0689282_2
R2025 Ae40
Ae Page number 40 Ae
AE1
Did the subjectexperience anyadverse e1
NO
21-APR-2010 12:59:41
Amanda Lynn
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 15:50:49 91Page
R264453213
L0689282_2 R20251726563513
SCREENING
VS 6PAGE_06
Heart Rate 1
CURRENT
No Action Required
UNIVARIATE
Resolved-Response Edited
046
Value of 046 for Heart Rate below expected minimum of 50
per our range it is 40-100 so within range.
Discrepancy Detail ReportDocument #:
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Value Text:
Type:
Review Status:
Discrepancy:
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Resolution Type:
Resolution Text:
Status:
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Visit Date:
Section:
Patient:
Qualifying Value:
Row:
Report run by Brian Saari at 05-MAR-2013 15:50:49 92Page
R264454113
L0689282_2 R202574041711
SCREENING
MH 9PAGE_09
Date 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
20090629
Please verify date of medical history (26-Jun-2009) as it is inconsistent with all otherScreening assessment dates (29-Jun-2009).
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Report run by Brian Saari at 05-MAR-2013 15:50:49 93Page
R264455513
L0689282_2 R20251735671013
BASELINE, WEEK
QUESTIONNAIRES 14PAGE_14
Date 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
20090713
Please use date of most recent baseline visit (7/13/09)
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Report run by Brian Saari at 05-MAR-2013 15:50:49 94Page
R266288013
L0689282_2 R20251735671613
IP, WEEK 6
VS 17PAGE_17
Respiratory Rate 1
CURRENT
Data value changed. Disc no longer applicable.
MANUAL
Resolved-Response Edited
18
Please review value
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Discrepancy ID:
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Report run by Brian Saari at 05-MAR-2013 15:50:49 95Page
R271133413
L0689282_2 R20251791879213
IP, WEEK 10
STATUS REVIEW 24PAGE_24
If Subject was not compliant, approximat 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
UNK
Per previous query. Site unable to contact subject and the amount is unknown, pleasereview and revise CRF page.
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Report run by Brian Saari at 05-MAR-2013 15:50:49 96Page
R264457013
L0689282_2 R202598540711
PCM
PCM 39PAGE_39
Indication 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
GENERAL ACHES AND PAIN
General aches and pains is not captured on MH. Please verify adding.
Verified. JLM 20Apr2010
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Value Text:
Type:
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Internal Comment:
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Report run by Brian Saari at 05-MAR-2013 15:50:49 97Page
R264457313
L0689282_2 R202598540811
PCM.1
PCM 39PAGE_39
Indication 1
CURRENT
Confirmed
MANUAL
Resolved-Response Edited
HEADACHES
Headaches is not currently captured on MH. Please verify adding.
updated medical history
Verified. JLM 20Apr2010
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Row:
Report run by Brian Saari at 05-MAR-2013 15:50:49 98Page
R264457613
L0689282_2 R20251735672013
PCM.2
PCM 39PAGE_39
CURRENT
Data value changed. Disc no longer applicable.
MANUAL HEADER
Resolved-Response Edited
Please enter dose as other and indicate the dates/tablets per progress note, unless thereis other instruction from the project/data manager. Please include the end date.
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Visit Date:
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Report run by Brian Saari at 05-MAR-2013 15:50:49 99Page
Deleted CRFs Report
