CTEP Branch Support Contracts Forms and Surveys (NCI)

Forms and Documents

Document	Type	Status	Availability
Form 97 Notification of Incarcerated Participant Form (Attachment B49)	Form and Instruction	New	Missing upstream
Form 96 Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48)	Form and Instruction	New	Repair queued
Form 95 CIRB Waiver of Consent Request Supplemental Form (Attachment B47)	Form and Instruction	New	Repair queued
Form 94 NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)	Form and Instruction	Modified	Repair queued
Form 1 NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)	Form	Modified	Repair queued
Form 92 NCI/DCTD/CTEP Biosketch (Attachment E02)	Form and Instruction	Modified	Repair queued
Form 91 NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)	Form and Instruction	Modified	Repair queued
Form 90 Final Report and CAPA Request Form (Attachment D07)	Form	Modified	Repair queued
Form 89 Roster Maintenance Form (Attachment D06)	Form	Modified	Repair queued
Form 88 Follow-up Form (Attachment D05)	Form	Modified	Repair queued
Form 87 Final Audit Finding Report Form (Attachment D04)	Form	Modified	Repair queued
Form 86 Audit Maintenance Form (Attachment D03)	Form	Modified	Repair queued
Form 85 Preliminary Audit Findings Form (Attachment D02)	Form	Modified	Repair queued
Form 84 Audit Scheduling Form (Attachment D01)	Form	Unchanged	Repair queued
Form 83 Request Waiver of Assent Form (Attachment B46)	Form	Modified	Repair queued
Form 82 CIRB Board Member Application (Attachment B3)	Form	Modified	Repair queued
Form 81 CTSU PDF Signature Form (Attachment A21)	Form	Modified	Repair queued
Form 80 CTSU Site Form Creation and PDF (Attachment A20)	Form	Unchanged	Repair queued
Form 79 CTSU LPO Form Creation (Attachment A19)	Form	Unchanged	Repair queued
Form 76 CTSU OPEN Rave Request Form (Attachment A18)	Form and Instruction	Modified	Repair queued
Form 75 Low Accural clinical Trial Survey (Attachment C11)	Form	Removed	Repair queued
Form 74 Prospective Clinical Trial Survey (Attachment C10)	Form	Removed	Repair queued
Form 73 Concept Clinical Trial Survey (Attachment C9)	Form	Removed	Repair queued
Form 72 PIO Customer Satisfaction Survey (Attachment C8)	Form	Modified	Repair queued
Form 71 CIRB Board member Annual Assessment Survey (Attachment C7)	Form	Modified	Repair queued
Form 66 Follow-up survey (Communication Audit) (Attachment C5)	Form	Modified	Repair queued
Form 65 CIRB Customer Satisfaction survey (Attachment C4)	Form	Modified	Repair queued
Form 64 CTSU OPEN Survey (Attachment C3)	Form	Modified	Repair queued
Form 61 Change of SI PI Form (Attachment B45)	Form	Modified	Repair queued
Form 60 UP or SCN Reporting Form (Attachment B44)	Form and Instruction	Unchanged	Repair queued
Form 59 Study Closure or Transfer of Study Review Responsibility Form (Attachment B43)	Form	Modified	Repair queued
Form 58 Study-Specific worksheet About Local Context (Attachment B42)	Form and Instruction	Modified	Repair queued
Form 57 Annual Principal Investigator Worksheet About Local Context (Attachment B41)	Form and Instruction	Modified	Repair queued
Form 56 Annual signatory Institution Worksheet About Local Context (Attachment B40)	Form and Instruction	Modified	Repair queued
Form 54 Reviewer Worksheet of Expedited IR (Attachment B38)	Form and Instruction	Modified	Repair queued
Form 52 Reviewer worksheet Expedited Study Closure Review (Attachment B36)	Form and Instruction	Modified	Repair queued
Form 51 Reviewer Worksheet of Recruitment Material (Attachment B35)	Form and Instruction	Modified	Repair queued
Form 50 Reviewer Worksheet of Translated Documents (Attachment B34)	Form and Instruction	Modified	Repair queued
Form 49 CIRB Application for Translated Documents (Attachment B33)	Form and Instruction	Modified	Repair queued
Form 48 Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32)	Form	Modified	Repair queued
Form 47 Reviewer Worksheet Determination of UP or SCN (Attachment B31)	Form and Instruction	Modified	Repair queued
Form 45 Adult Expedited Study Chair Response to Required Mod (Attachment B29)	Form	Modified	Repair queued
Form 44 Pediatric Cooperative Group Response to CIRB Review (Attachment B28)	Form and Instruction	Modified	Repair queued
Form 43 Adult Cooperative Group Response to CIRB Review (Attachment B27)	Form and Instruction	Modified	Repair queued
Form 42 Pediatric Expedited Continuing Review (Attachment B26)	Form and Instruction	Modified	Repair queued
Form 41 Adult Expedited Continuing Review (Attachment B25)	Form and Instruction	Modified	Repair queued
Form 40 Pediatric Expedited Amendment Review (Attachment B24)	Form and Instruction	Modified	Repair queued
Form 39 Adult Expedited Amendment Review (Attachment B23)	Form and Instruction	Modified	Missing upstream
Form 38 CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)	Form and Instruction	Removed	Repair queued
Form 37 Pharmacist's Review of a Cooperative Group Study (Attachment B21)	Form and Instruction	Modified	Repair queued
Form 36 Pediatric Amendment of Cooperative Group Protocol (Attachment B20)	Form and Instruction	Modified	Repair queued
Form 35 Adult amendment of Cooperative Group Protocol (Attachment B19)	Form and Instruction	Modified	Repair queued
Form 33 Adult Continuing Review of Cooperative Group Protocol (Attachment B17)	Form and Instruction	Modified	Missing upstream
Form 32 Pediatric IR of Cooperative Group Protocol (Attachment B16)	Form and Instruction	Modified	Repair queued
Form 31 Adult IR of cooperative Group Protocol (Attachment B15)	Form and Instruction	Modified	Repair queued
Form 30 CIRB Continuing Review Application (Attachment B14)	Form	Modified	Missing upstream
Form 29 CIRB Ancillary Studies Application (Attachment B13)	Form and Instruction	Modified	Repair queued
Form 28 CIRB Amendment Review Application (Attachment B12)	Form and Instruction	Modified	Missing upstream
Form 27 CIRB IR Application for Exempt Studies (Attachment B11)	Form and Instruction	Modified	Repair queued
Form 26 CIRB IR Application (Attachment B10)	Form and Instruction	Modified	Repair queued
Form 25 CIRB COI Screening for CIRB meetings (Attachment B9)	Form and Instruction	Modified	Repair queued
Form 24 CIRB Member COI Screening Worksheet (Attachment B8)	Form	Modified	Repair queued
Form 19 NCI CIRB Signatory Enrollment Form (Attachment B2)	Form and Instruction	Modified	Repair queued
Form 18 NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)	Form and Instruction	Modified	Repair queued
Form 17 CTSU System Access Request Form (Attachment A17)	Form and Instruction	Modified	Repair queued
Form 16 CTSU Transfer Form (Attachment A16)	Form and Instruction	Unchanged	Repair queued
Form 15 CTSU Patient Enrollment Transmittal Form (Attachment A15)	Form and Instruction	Unchanged	Repair queued
Form 12 CTSU Generic Data transmittal form (Attachment A12)	Form and Instruction	Removed	Repair queued
Form 10 RTOG 0834 CTSU Data Transmittal Form (Attachment A10)	Form and Instruction	Modified	Repair queued
Form 9 Data Clarification Form (Attachment A9)	Form and Instruction	Removed	Repair queued
Form 8 Site Initated Data Update Form (Attachment A8)	Form and Instruction	Removed	Repair queued
Form 7 CTSU Supply Request Form (Attachment A7)	Form and Instruction	Unchanged	Missing upstream
Form 6 CTSU Request for Clinical Brochure (Attachment A6)	Form and Instruction	Unchanged	Repair queued
Form 5 CTSU Roster Update Form (Attachment A5)	Form and Instruction	Removed	Repair queued
Form 4 Site Addition Form (Attachment A4)	Form and Instruction	Unchanged	Repair queued
Form 3 Withdrawl from Protocol Participation Form (Attachment A3)	Form and Instruction	Unchanged	Repair queued
Form 2 CTSU IRB Certification Form (Attachment A2)	Form and Instruction	Unchanged	Repair queued
Form 1 CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)	Form and Instruction	Modified	Repair queued
pub 30 day FRN2021-03046.pdf	Supplementary Document	Uploaded 2021-02-16	Missing upstream
SSA CTEP Jan 2021.docx	Supporting Statement A	Uploaded 2021-01-29	Repair queued
SSB CTEP Dec 2020.docx	Supporting Statement B	Uploaded 2021-01-29	Repair queued
Attachment_F10_CTEPESYS_FIPS.pdf	Supplementary Document	Uploaded 2021-01-28	Repair queued
Attachment_F09_CTEP_PIA_2018.pdf	Supplementary Document	Uploaded 2021-01-28	Repair queued
Attachment_F06 - CIRB - Emmes IRB_exempt_09_2016.pdf	Supplementary Document	Uploaded 2021-01-28	Repair queued
Attachment_F05 - CIRB - OHSR Determination.pdf	Supplementary Document	Uploaded 2021-01-28	Repair queued
Attachment_F04_CIRB_FIPS.pdf	Supplementary Document	Uploaded 2021-01-28	Missing upstream
Attachment_F03 - Privacy Act Memo.pdf	Supplementary Document	Uploaded 2021-01-28	Repair queued
Attachment_F02_IRB and OHSR determination.pdf	Supplementary Document	Uploaded 2021-01-28	Repair queued
Attachment_F01_CTSU_PIAn.pdf	Supplementary Document	Uploaded 2021-01-28	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
245475	Notification of Incarcerated Participant Form (Attachment B49)	Form and Instruction	New
245474	Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48)	Form and Instruction	New
245472	CIRB Waiver of Consent Request Supplemental Form (Attachment B47)	Form and Instruction	New
230005	NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)	Form and Instruction	Modified
230004	NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)	Form	Modified
230003	NCI/DCTD/CTEP Biosketch (Attachment E02)	Form and Instruction	Modified
230002	NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)	Form and Instruction	Modified
230001	Final Report and CAPA Request Form (Attachment D07)	Form	Modified
230000	Roster Maintenance Form (Attachment D06)	Form	Modified
229999	Follow-up Form (Attachment D05)	Form	Modified
229998	Final Audit Finding Report Form (Attachment D04)	Form	Modified
229997	Audit Maintenance Form (Attachment D03)	Form	Modified
229995	Preliminary Audit Findings Form (Attachment D02)	Form	Modified
229993	Audit Scheduling Form (Attachment D01)	Form	Unchanged
229991	Request Waiver of Assent Form (Attachment B46)	Form	Modified
229989	CIRB Board Member Application (Attachment B3)	Form	Modified
229988	CTSU PDF Signature Form (Attachment A21)	Form	Modified
229986	CTSU Site Form Creation and PDF (Attachment A20)	Form	Unchanged
229985	CTSU LPO Form Creation (Attachment A19)	Form	Unchanged
229984	CTSU OPEN Rave Request Form (Attachment A18)	Form and Instruction	Modified
225929	Low Accural clinical Trial Survey (Attachment C11)	Form	Removed
225928	Prospective Clinical Trial Survey (Attachment C10)	Form	Removed
225927	Concept Clinical Trial Survey (Attachment C9)	Form	Removed
225926	PIO Customer Satisfaction Survey (Attachment C8)	Form	Modified
225925	CIRB Board member Annual Assessment Survey (Attachment C7)	Form	Modified
225923	Follow-up survey (Communication Audit) (Attachment C5)	Form	Modified
225922	CIRB Customer Satisfaction survey (Attachment C4)	Form	Modified
225921	CTSU OPEN Survey (Attachment C3)	Form	Modified
225917	Change of SI PI Form (Attachment B45)	Form	Modified
225916	UP or SCN Reporting Form (Attachment B44)	Form and Instruction	Unchanged
225915	Study Closure or Transfer of Study Review Responsibility Form (Attachment B43)	Form	Modified
225914	Study-Specific worksheet About Local Context (Attachment B42)	Form and Instruction	Modified
225913	Annual Principal Investigator Worksheet About Local Context (Attachment B41)	Form and Instruction	Modified
225912	Annual signatory Institution Worksheet About Local Context (Attachment B40)	Form and Instruction	Modified
225910	Reviewer Worksheet of Expedited IR (Attachment B38)	Form and Instruction	Modified
225908	Reviewer worksheet Expedited Study Closure Review (Attachment B36)	Form and Instruction	Modified
225907	Reviewer Worksheet of Recruitment Material (Attachment B35)	Form and Instruction	Modified
225906	Reviewer Worksheet of Translated Documents (Attachment B34)	Form and Instruction	Modified
225904	CIRB Application for Translated Documents (Attachment B33)	Form and Instruction	Modified
225903	Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32)	Form	Modified
225902	Reviewer Worksheet Determination of UP or SCN (Attachment B31)	Form and Instruction	Modified
225900	Adult Expedited Study Chair Response to Required Mod (Attachment B29)	Form	Modified
225899	Pediatric Cooperative Group Response to CIRB Review (Attachment B28)	Form and Instruction	Modified
225898	Adult Cooperative Group Response to CIRB Review (Attachment B27)	Form and Instruction	Modified
225897	Pediatric Expedited Continuing Review (Attachment B26)	Form and Instruction	Modified
225895	Adult Expedited Continuing Review (Attachment B25)	Form and Instruction	Modified
225894	Pediatric Expedited Amendment Review (Attachment B24)	Form and Instruction	Modified
225893	Adult Expedited Amendment Review (Attachment B23)	Form and Instruction	Modified
225892	CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)	Form and Instruction	Removed
225891	Pharmacist's Review of a Cooperative Group Study (Attachment B21)	Form and Instruction	Modified
225890	Pediatric Amendment of Cooperative Group Protocol (Attachment B20)	Form and Instruction	Modified
225889	Adult amendment of Cooperative Group Protocol (Attachment B19)	Form and Instruction	Modified
225887	Adult Continuing Review of Cooperative Group Protocol (Attachment B17)	Form and Instruction	Modified
225886	Pediatric IR of Cooperative Group Protocol (Attachment B16)	Form and Instruction	Modified
225885	Adult IR of cooperative Group Protocol (Attachment B15)	Form and Instruction	Modified
225884	CIRB Continuing Review Application (Attachment B14)	Form	Modified
225883	CIRB Ancillary Studies Application (Attachment B13)	Form and Instruction	Modified
225882	CIRB Amendment Review Application (Attachment B12)	Form and Instruction	Modified
225881	CIRB IR Application for Exempt Studies (Attachment B11)	Form and Instruction	Modified
225880	CIRB IR Application (Attachment B10)	Form and Instruction	Modified
225879	CIRB COI Screening for CIRB meetings (Attachment B9)	Form and Instruction	Modified
225878	CIRB Member COI Screening Worksheet (Attachment B8)	Form	Modified
225873	NCI CIRB Signatory Enrollment Form (Attachment B2)	Form and Instruction	Modified
225871	NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)	Form and Instruction	Modified
225870	CTSU System Access Request Form (Attachment A17)	Form and Instruction	Modified
225868	CTSU Transfer Form (Attachment A16)	Form and Instruction	Unchanged
225866	CTSU Patient Enrollment Transmittal Form (Attachment A15)	Form and Instruction	Unchanged
225861	CTSU Generic Data transmittal form (Attachment A12)	Form and Instruction	Removed
225857	RTOG 0834 CTSU Data Transmittal Form (Attachment A10)	Form and Instruction	Modified
225853	Data Clarification Form (Attachment A9)	Form and Instruction	Removed
225852	Site Initated Data Update Form (Attachment A8)	Form and Instruction	Removed
225850	CTSU Supply Request Form (Attachment A7)	Form and Instruction	Unchanged
225847	CTSU Request for Clinical Brochure (Attachment A6)	Form and Instruction	Unchanged
225846	CTSU Roster Update Form (Attachment A5)	Form and Instruction	Removed
225845	Site Addition Form (Attachment A4)	Form and Instruction	Unchanged
225844	Withdrawl from Protocol Participation Form (Attachment A3)	Form and Instruction	Unchanged
225843	CTSU IRB Certification Form (Attachment A2)	Form and Instruction	Unchanged
225841	CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)	Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0753	ICR Reference No: 202012-0925-003
Status: Received in OIRA	Previous ICR Reference No: 201908-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: CTEP Branch Support Contracts Forms and Surveys (NCI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/16/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2021
Responses	235,670	207,989
Time Burden (Hours)	151,792	112,838
Cost Burden (Dollars)	0	0

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Abstract: This is a revised information collection for OMB control number #0925-0753, expiration 7/31/2021 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).

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Authorizing Statute(s): US Code: 42 USC 285a Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 63561	10/08/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 9524	02/16/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 70

IC Title	Form No.	Form Name
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)	38	CPC FB Pharma Reviewer Worksheet
Prospective Clinical Trial Survey (Attachment C10)	74	Prospective Survey
CIRB IR Application for Exempt Studies (Attachment B11)	27	CIRB IR Exempt Application
CIRB Continuing Review Application (Attachment B14)	30	CIRB CR Application
Pediatric Amendment of Cooperative Group Protocol (Attachment B20)	36	Ped AR FB Reviewer Worksheet
CTSU Roster Update Form (Attachment A5)	5	Roster Update
Site Initated Data Update Form (Attachment A8)	8	Site Data Update form
Data Clarification Form (Attachment A9)	9	Data Clarification Form
CTSU Generic Data transmittal form (Attachment A12)	12	Generic Data
CIRB Waiver of Consent Request Supplemental Form (Attachment B47)	95	CIRB WoC Supp
Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48)	96	Attachment B48 Prisoner FB Reviewer Worksheet
Notification of Incarcerated Participant Form (Attachment B49)	97	Attachment B49 Incarcerated Participant Wrksht
Low Accural clinical Trial Survey (Attachment C11)	75	low accuring survey
Pharmacist's Review of a Cooperative Group Study (Attachment B21)	37	Adult Ped FB Pharma Adult Reviewer Worksheet
Reviewer Worksheet Determination of UP or SCN (Attachment B31)	47	Reviewer Worksheet UP FB
Reviewer Worksheet of Recruitment Material (Attachment B35)	51	Reviewer Worksheet Recruitment materials
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)	1	IRB Transmittal
Withdrawl from Protocol Participation Form (Attachment A3)	3	Withdrawal Form
Request Waiver of Assent Form (Attachment B46)	83	Waiver Assent Worksheet
Annual Principal Investigator Worksheet About Local Context (Attachment B41)	57	Annual PI Worksheet
UP or SCN Reporting Form (Attachment B44)	60	Unanticipated Problem Worksheet
Change of SI PI Form (Attachment B45)	61	Change PI Worksheet
CIRB Customer Satisfaction survey (Attachment C4)	65	CIRB Satisfaction survey
Concept Clinical Trial Survey (Attachment C9)	73	Concept Survey
Pediatric Expedited Amendment Review (Attachment B24)	40	Ped Expedited Reviewer Worksheet
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43)	59	Study Closure Transfer Worksheet
CTSU IRB Certification Form (Attachment A2)	2	IRB Certification
Site Addition Form (Attachment A4)	4	Site Addition
Audit Maintenance Form (Attachment D03)	86	Aud Maint
Final Report and CAPA Request Form (Attachment D07)	90	Final Report CAPA Reg.
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)	18	NCI CIRB AA DivofResps
Adult Cooperative Group Response to CIRB Review (Attachment B27)	43	Adult & CPC FB SCRWksht
Adult Expedited Study Chair Response to Required Mod (Attachment B29)	45	ER SCRwksht CIRB-ReviewRegMods
RTOG 0834 CTSU Data Transmittal Form (Attachment A10)	10	RTOG0834
CTSU Patient Enrollment Transmittal Form (Attachment A15)	15	patient Enrollment Transmittal Form
CTSU Supply Request Form (Attachment A7)	7	Supply
CTSU Transfer Form (Attachment A16)	16	Transfer
NCI CIRB Signatory Enrollment Form (Attachment B2)	19	NCI CIRB Signatory Enrollment Form
CIRB Member COI Screening Worksheet (Attachment B8)	24	CIRB COI Update
CIRB COI Screening for CIRB meetings (Attachment B9)	25	COI Screening
CIRB Ancillary Studies Application (Attachment B13)	29	CIRB Ancillary Application
Adult IR of cooperative Group Protocol (Attachment B15)	31	Adult IR FB Reviewer Worksheet
Adult Continuing Review of Cooperative Group Protocol (Attachment B17)	33	Adult CR FB Reviewer Worksheet
Adult Expedited Amendment Review (Attachment B23)	39	Adult & CPC Expedited Reviewer Worksheet
Pediatric Expedited Continuing Review (Attachment B26)	42	Ped Expedited CR Worksheet
Pediatric Cooperative Group Response to CIRB Review (Attachment B28)	44	Ped FB SCRWksht
Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32)	48	Current CIRB Stat Reviewer Worksheet
CIRB Application for Translated Documents (Attachment B33)	49	CIRB App for Translated Docs
PIO Customer Satisfaction Survey (Attachment C8)	72	PIO External Survey
CIRB Amendment Review Application (Attachment B12)	28	CIRB AR Application
Pediatric IR of Cooperative Group Protocol (Attachment B16)	32	Ped IR FB Reviewerworksheet
Adult amendment of Cooperative Group Protocol (Attachment B19)	35	Adult AR FB Reviewer Worksheet
CTSU Request for Clinical Brochure (Attachment A6)	6	Clinical Brochure
Reviewer worksheet Expedited Study Closure Review (Attachment B36)	52	reviewer Worksheet ER ClosureWksht
Reviewer Worksheet of Expedited IR (Attachment B38)	54	Reviewer Worksheet ER IR
Follow-up survey (Communication Audit) (Attachment C5)	66	CIRB FUP Survey
Reviewer Worksheet of Translated Documents (Attachment B34)	50	Reviewer Worksheet Translated Docs
Study-Specific worksheet About Local Context (Attachment B42)	58	SSW Worksheet
CTSU LPO Form Creation (Attachment A19)	79	Protocol Specific DTL
CIRB Board Member Application (Attachment B3)	82	Board member application
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)	91	CTEP FDA Form 1572 for Annual Submission
CTSU OPEN Rave Request Form (Attachment A18)	76	CTSU-OPEN Rave-Form
Final Audit Finding Report Form (Attachment D04)	87	Final Audit Finding
CTSU Site Form Creation and PDF (Attachment A20)	80	Site Prot DTL
CTSU PDF Signature Form (Attachment A21)	81	Elec Sig Page
Audit Scheduling Form (Attachment D01)	84	Audit Schedule
Preliminary Audit Findings Form (Attachment D02)	85	Preliminary Audit Findings
NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)	94	Shipment Form (ASF)
Follow-up Form (Attachment D05)	88	Follow up
Roster Maintenance Form (Attachment D06)	89	Roster Maintenance
NCI/DCTD/CTEP Biosketch (Attachment E02)	92	Biosketch
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)	1	Financial Disclosure
CTSU System Access Request Form (Attachment A17)	17	System Access Request Form
CIRB IR Application (Attachment B10)	26	CIRB IR Application
Adult Expedited Continuing Review (Attachment B25)	41	Adult & CPC Expedited CR Worksheet
Annual signatory Institution Worksheet About Local Context (Attachment B40)	56	Annual SI Worksheet
CTSU OPEN Survey (Attachment C3)	64	OPEN survey
CIRB Board member Annual Assessment Survey (Attachment C7)	71	CIRB Board Member Annual Assessment

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ICR Summary of Burden

	Total Request	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	235,670	207,989	0	27,681	0	0
Annual Time Burden (Hours)	151,792	112,838	0	38,954	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This revision removes several forms and surveys and adds new forms for the CIRB. The burden from the previously approved submission was 112,798 hours and with these changes, it has increased to 151,792 hours. The net change is an increase of 38,994 hours. The increase in total burden hours is driven by an increase in the number of respondents for the PMB forms (E01 – E04). From the 2018 submission, the total burden hours for PMB forms was 78,333 hours. For the current submission the total burden hours for PMB forms is 118,625. The addition of new CIRB forms increased burden for the CIRB forms by 32 hours annually, and the removal of several CTSU forms and surveys decreased the overall burden by 740 hours annually.

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Annual Cost to Federal Government: $1,529,246

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? No

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Common Form ICR:  No

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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: 02/16/2021

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