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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Adult Continuing Review of Cooperative Group Protocol (Attachment B17)
New
275
275
0
Form and Instruction
33
Adult CR FB Reviewer Worksheet
Adult Cooperative Group Response to CIRB Review (Attachment B27)
New
30
30
0
Form and Instruction
43
Adult & CPC FB SCRWksht
Adult Expedited Amendment Review (Attachment B23)
New
348
174
0
Form and Instruction
39
Adult & CPC Expedited Reviewer Worksheet
Adult Expedited Continuing Review (Attachment B25)
New
140
70
0
Form and Instruction
41
Adult & CPC Expedited CR Worksheet
Adult Expedited Study Chair Response to Required Mod (Attachment B29)
New
40
10
0
Form and Instruction
45
Adult & CPC Exped Chair Resp Req Mods
Adult IR of cooperative Group Protocol (Attachment B15)
New
65
195
0
Form and Instruction
31
Adult IR FB Reviewer Worksheet
Adult amendment of Cooperative Group Protocol (Attachment B19)
New
40
80
0
Form and Instruction
35
Adult AR FB Reviewer Worksheet
Annual Principal Investigator Worksheet About Local Context (Attachment B41)
New
1800
600
0
Form and Instruction
57
Annual PI Worksheet
Annual signatory Institution Worksheet About Local Context (Attachment B40)
New
400
267
0
Form and Instruction
56
Annual SI Worksheet
CIRB Amendment Review Application (Attachment B12)
New
400
100
0
Form and Instruction
28
CIRB AR Application
CIRB Ancillary Studies Application (Attachment B13)
New
1
1
0
Form and Instruction
29
CIRB Ancillary Application
CIRB Application for Translated Documents (Attachment B33)
New
100
50
0
Form and Instruction
49
CIRB App for Translated Docs
CIRB Board Member NDA (Attachment B6)
New
25
4
0
Form and Instruction
22
CIRB Member NDA
CIRB Board member Annual Assessment Survey (Attachment C7)
New
60
20
0
Form
71
Annual CIRB Board Assessment
CIRB Board member Biographical Sketch (Attachment B3)
New
25
6
0
Form and Instruction
20
CIRB Biosketch Questions CIRB member
CIRB Board member Contact Information Form (Attachment B4)
New
25
4
0
Form and Instruction
21
CIRB ContactInfoForm
CIRB COI Screening for CIRB meetings (Attachment B9)
New
72
18
0
Form and Instruction
25
COI Screening
CIRB Continuing Review Application (Attachment B14)
New
400
200
0
Form and Instruction
30
CIRB CR Application
CIRB Customer Satisfaction survey (Attachment C4)
New
600
150
0
Form
65
CIRB Satisfaction survey
CIRB Direct Deposit Form (Attachment B7)
New
25
6
0
Form
23
CIRB Direct Deposit Form
CIRB IR Application (Attachment B10)
New
80
80
0
Form and Instruction
26
CIRB IR Application
CIRB IR Application for Exempt Studies (Attachment B11)
New
4
2
0
Form and Instruction
27
CIRB IR Exempt Application
CIRB Member COI Screening Worksheet (Attachment B8)
New
12
6
0
Form and Instruction
24
COI Screen
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)
New
20
40
0
Form and Instruction
38
CPC FB Pharma Reviewer Worksheet
CTSU Generic Data transmittal form (Attachment A12)
New
60
10
0
Form and Instruction
12
Generic Data
CTSU Help Desk Customer Satisfaction Survey (Attachment C2)
New
325
81
0
Form and Instruction
63
Help Desk Survey
CTSU IRB Certification Form (Attachment A2)
New
29328
4888
0
Form and Instruction
2
IRB Certification
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)
New
29328
978
0
Form and Instruction
1
IRB Transmittal
CTSU OPEN Survey (Attachment C3)
New
60
15
0
Form
64
OPEN survey
CTSU Patient Enrollment Transmittal Form (Attachment A15)
New
144
24
0
Form and Instruction
15
Patient Enrollment Transmittal form
CTSU Request for Clinical Brochure (Attachment A6)
New
360
60
0
Form and Instruction
6
Clinical Brochure
CTSU Roster Update Form (Attachment A5)
New
600
50
0
Form and Instruction
5
Roster Update
CTSU Supply Request Form (Attachment A7)
New
1080
180
0
Form and Instruction
7
Supply
CTSU System Access Request Form (Attachment A17)
New
180
60
0
Form and Instruction
17
System Access Request form
CTSU Transfer Form (Attachment A16)
New
720
120
0
Form and Instruction
16
Transfer
CTSU Website Customer Satisfaction Survey (Attachment C1)
New
275
69
0
Form
62
websurvey final
Change of SI PI Form (Attachment B45)
New
120
30
0
Form and Instruction
61
Change PI Worksheet
Concept Clinical Trial Survey (Attachment C9)
New
500
42
0
Form
73
Concept Survey
Data Clarification Form (Attachment A9)
New
3600
600
0
Form and Instruction
9
Data Clarification Form
ETCTN PI Survey (Attachment C12)
New
75
19
0
Form
76
ETCTN PI Survey
ETCTN RS Survey (Attachment C13)
New
175
44
0
Form
77
ETCTN
Follow-up survey (Communication Audit) (Attachment C5)
New
300
75
0
Form
66
CIRB FUP Survey
Low Accural clinical Trial Survey (Attachment C11)
New
1000
17
0
Form
75
low accuring survey
MC0845 (8233) CTSU Data Transmittal Form (Attachment A11)
New
60
10
0
Form and Instruction
11
8233 Form
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)
New
50
13
0
Form and Instruction
18
NCI CIRB AA DivofResps
NCI CIRB Signatory Enrollment Form (Attachment B2)
New
50
13
0
Form and Instruction
19
NCI CIRB Signatory Enrollment Form
PIO Customer Satisfaction Survey (Attachment C8)
New
60
5
0
Form
72
PIO External Survey
Pediatric Amendment of Cooperative Group Protocol (Attachment B20)
New
25
50
0
Form and Instruction
36
Ped AR FB Reviewer Worksheet
Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18)
New
130
130
0
Form and Instruction
34
Oed CR FB Reviewer Worksheet
Pediatric Cooperative Group Response to CIRB Review (Attachment B28)
New
5
5
0
Form and Instruction
44
Ped FB SCRWksht
Pediatric Expedited Amendment Review (Attachment B24)
New
140
70
0
Form and Instruction
40
Ped Expedited Reviewer Worksheet
Pediatric Expedited Continuing Review (Attachment B26)
New
36
18
0
Form and Instruction
42
Ped Expedited CR Worksheet
Pediatric Expedited Strudy Chair Response to Required Mod (Attachment B30)
New
40
10
0
Form and Instruction
46
Ped Exped Chair Resp Req Mods
Pediatric IR of Cooperative Group Protocol (Attachment B16)
New
15
45
0
Form and Instruction
32
Ped IR FB Reviewerworksheet
Pharmacist's Review of a Cooperative Group Study (Attachment B21)
New
10
20
0
Form and Instruction
37
Adult Ped FB Pharma Adult Reviewer Worksheet
Prospective Clinical Trial Survey (Attachment C10)
New
1000
17
0
Form
74
Prospective Survey
RTOG 0834 CTSU Data Transmittal Form (Attachment A10)
New
912
152
0
Form and Instruction
10
RTOG0834
Reviewer Worksheet CPC - Determination of UP or SCN (Attachment B39)
New
40
10
0
Form and Instruction
55
Reviewer Worksheet CPC UP FB
Reviewer Worksheet Determination of UP or SCN (Attachment B31)
New
360
60
0
Form and Instruction
47
Reviewer Worksheet UP FB
Reviewer Worksheet expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37)
New
5
3
0
Form and Instruction
53
Reviewer Worksheet SCR ER
Reviewer Worksheet of Expedited IR (Attachment B38)
New
5
3
0
Form and Instruction
54
Reviewer Worksheet ER IR
Reviewer Worksheet of Recruitment Material (Attachment B35)
New
20
5
0
Form and Instruction
51
Reviewer Worksheet Recruitment materials
Reviewer Worksheet of Translated Documents (Attachment B34)
New
100
25
0
Form and Instruction
50
Reviewer Worksheet Translated Docs
Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32)
New
100
100
0
Form and Instruction
48
reviewer Worksheet CIRB Stat
Reviewer worksheet Expedited Study Closure Review (Attachment B36)
New
20
5
0
Form and Instruction
52
reviewer Worksheet ER ClosureWksht
Site Addition Form (Attachment A4)
New
960
160
0
Form and Instruction
4
Site Addition
Site Initated Data Update Form (Attachment A8)
New
24
4
0
Form and Instruction
8
Site Data Update form
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43)
New
1680
420
0
Form and Instruction
59
Study Closure Worksheet
Study-Specific worksheet About Local Context (Attachment B42)
New
4800
1600
0
Form and Instruction
58
SSW Worksheet
TAILORx_PACCT1_Data Transmittal Form (Attachment A13)
New
15456
2576
0
Form and Instruction
13
TAILORx PACCT1_DTF
UP or SCN Reporting Form (Attachment B44)
New
360
120
0
Form and Instruction
60
Unanticipated Problem Worksheet
Uncolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment A14)
New
360
60
0
Form and Instruction
14
TAILORx UDM
Website Focus Groups, Communication Project (Attachments C6 A-D)
New
18
18
0
Form
67
CIRB Website Focus Group Survey - CIRB Members usability
Form
68
CIRB Website Focus Group Survey - Local Instiutions usability
Form
69
CIRB Website Focus Group Survey - Network Groups usability
Form
70
CIRB Website Focus Group Survey -Web site usability testing
Withdrawl from Protocol Participation Form (Attachment A3)
New
279
47
0
Form and Instruction
3
Withdrawl form
Total burden requested under this ICR:
100337
15524
0
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