View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0753
ICR Reference No:
201809-0925-002
Status:
Historical Active
Previous ICR Reference No:
201802-0925-001
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
CTEP Branch Support Contracts Forms and Surveys (NCI)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/28/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/25/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2021
07/31/2021
07/31/2021
Responses
207,989
0
207,989
Time Burden (Hours)
112,838
0
112,838
Cost Burden (Dollars)
0
0
0
Abstract:
This is a revised information collection for OMB control number #0925-0753, expiration 6/30/2020 for three years. The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder (FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53).
Authorizing Statute(s):
US Code:
42 USC 285a
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 7483
02/21/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 18576
04/27/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
75
IC Title
Form No.
Form Name
Adult Continuing Review of Cooperative Group Protocol (Attachment B17)
33
Adult CR FB Reviewer Worksheet
Adult Cooperative Group Response to CIRB Review (Attachment B27)
43
Adult & CPC FB SCRWksht
Adult Expedited Amendment Review (Attachment B23)
39
Adult & CPC Expedited Reviewer Worksheet
Adult Expedited Continuing Review (Attachment B25)
41
Adult & CPC Expedited CR Worksheet
Adult Expedited Study Chair Response to Required Mod (Attachment B29)
45
ER SCRwksht CIRB-ReviewRegMods
Adult IR of cooperative Group Protocol (Attachment B15)
31
Adult IR FB Reviewer Worksheet
Adult amendment of Cooperative Group Protocol (Attachment B19)
35
Adult AR FB Reviewer Worksheet
Annual Principal Investigator Worksheet About Local Context (Attachment B41)
57
Annual PI Worksheet
Annual signatory Institution Worksheet About Local Context (Attachment B40)
56
Annual SI Worksheet
Audit Maintenance Form (Attachment D03)
86
Aud Maint
Audit Scheduling Form (Attachment D01)
84
Audit Schedule
CIRB Amendment Review Application (Attachment B12)
28
CIRB AR Application
CIRB Ancillary Studies Application (Attachment B13)
29
CIRB Ancillary Application
CIRB Application for Translated Documents (Attachment B33)
49
CIRB App for Translated Docs
CIRB Board Member Application (Attachment B3)
82
Board member application
CIRB Board member Annual Assessment Survey (Attachment C7)
71
CIRB Board Member Annual Assessment
CIRB COI Screening for CIRB meetings (Attachment B9)
25
COI Screening
CIRB Continuing Review Application (Attachment B14)
30
CIRB CR Application
CIRB Customer Satisfaction survey (Attachment C4)
65
CIRB Satisfaction survey
CIRB IR Application (Attachment B10)
26
CIRB IR Application
CIRB IR Application for Exempt Studies (Attachment B11)
27
CIRB IR Exempt Application
CIRB Member COI Screening Worksheet (Attachment B8)
24
CIRB COI Update
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)
38
CPC FB Pharma Reviewer Worksheet
CTSU Generic Data transmittal form (Attachment A12)
12
Generic Data
CTSU IRB Certification Form (Attachment A2)
2
IRB Certification
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)
1
IRB Transmittal
CTSU LPO Form Creation (Attachment A19)
79
Protocol Specific DTL
CTSU OPEN Rave Request Form (Attachment A18)
78
CTSU OPEN RaveRegForm
CTSU OPEN Survey (Attachment C3)
64
OPEN survey
CTSU PDF Signature Form (Attachment 21)
81
Elec Sig Page
CTSU Patient Enrollment Transmittal Form (Attachment A15)
15
patient Enrollment Transmittal Form
CTSU Request for Clinical Brochure (Attachment A6)
6
Clinical Brochure
CTSU Roster Update Form (Attachment A5)
5
Roster Update
CTSU Site Form Creation and PDF (Attachment A20)
80
Site Prot DTL
CTSU Supply Request Form (Attachment A7)
7
Supply
CTSU System Access Request Form (Attachment A17)
17
System Access Request Form
CTSU Transfer Form (Attachment A16)
16
Transfer
Change of SI PI Form (Attachment B45)
61
Change PI Worksheet
Concept Clinical Trial Survey (Attachment C9)
73
Concept Survey
Data Clarification Form (Attachment A9)
9
Data Clarification Form
Final Audit Finding Report Form (Attachment D04)
87
Final Audit Finding
Final Report and CAPA Request Form (Attachment D07)
90
Final Report CAPA Reg.
Follow-up Form (Attachment D05)
88
Follow up
Follow-up survey (Communication Audit) (Attachment C5)
66
CIRB FUP Survey
Low Accural clinical Trial Survey (Attachment C11)
75
low accuring survey
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)
18
NCI CIRB AA DivofResps
NCI CIRB Signatory Enrollment Form (Attachment B2)
19
NCI CIRB Signatory Enrollment Form
NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)
94
Shipment Form (ASF)
NCI/DCTD/CTEP Biosketch (Attachment E02)
92
Biosketch
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)
91
CTEP FDA Form 1572 for Annual Submission
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)
93
Fin Disclosure
PIO Customer Satisfaction Survey (Attachment C8)
72
PIO External Survey
Pediatric Amendment of Cooperative Group Protocol (Attachment B20)
36
Ped AR FB Reviewer Worksheet
Pediatric Cooperative Group Response to CIRB Review (Attachment B28)
44
Ped FB SCRWksht
Pediatric Expedited Amendment Review (Attachment B24)
40
Ped Expedited Reviewer Worksheet
Pediatric Expedited Continuing Review (Attachment B26)
42
Ped Expedited CR Worksheet
Pediatric IR of Cooperative Group Protocol (Attachment B16)
32
Ped IR FB Reviewerworksheet
Pharmacist's Review of a Cooperative Group Study (Attachment B21)
37
Adult Ped FB Pharma Adult Reviewer Worksheet
Preliminary Audit Findings Form (Attachment D02)
85
Preliminary Audit Findings
Prospective Clinical Trial Survey (Attachment C10)
74
Prospective Survey
RTOG 0834 CTSU Data Transmittal Form (Attachment A10)
10
RTOG0834
Request Waiver of Assent Form (Attachment B46)
83
Waiver Assent Worksheet
Reviewer Worksheet Determination of UP or SCN (Attachment B31)
47
Reviewer Worksheet UP FB
Reviewer Worksheet of Expedited IR (Attachment B38)
54
Reviewer Worksheet ER IR
Reviewer Worksheet of Recruitment Material (Attachment B35)
51
Reviewer Worksheet Recruitment materials
Reviewer Worksheet of Translated Documents (Attachment B34)
50
Reviewer Worksheet Translated Docs
Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32)
48
Current CIRB Stat Reviewer Worksheet
Reviewer worksheet Expedited Study Closure Review (Attachment B36)
52
reviewer Worksheet ER ClosureWksht
Roster Maintenance Form (Attachment D06)
89
Roster Maintenance
Site Addition Form (Attachment A4)
4
Site Addition
Site Initated Data Update Form (Attachment A8)
8
Site Data Update form
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43)
59
Study Closure Transfer Worksheet
Study-Specific worksheet About Local Context (Attachment B42)
58
SSW Worksheet
UP or SCN Reporting Form (Attachment B44)
60
Unanticipated Problem Worksheet
Withdrawl from Protocol Participation Form (Attachment A3)
3
Withdrawal Form
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
207,989
207,989
0
0
0
0
Annual Time Burden (Hours)
112,838
112,838
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$1,613,105
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
09/25/2018
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