CTEP Branch Support Contracts Forms and Surveys (NCI)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 94 Shipment Form (ASF)	Form and Instruction	Unchanged	Available
Form 1 Financial Disclosure	Form	Unchanged	Repair queued
Form 93 Fin Disclosure	Form	Unchanged	Available
Form 92 Biosketch	Form and Instruction	Unchanged	Available
Form 91 CTEP FDA Form 1572 for Annual Submission	Form and Instruction	Unchanged	Available
Form 90 Final Report CAPA Reg.	Form	Unchanged	Available
Form 89 Roster Maintenance	Form	Unchanged	Available
Form 88 Follow up	Form	Unchanged	Repair queued
Form 87 Final Audit Finding	Form	Unchanged	Available
Form 86 Aud Maint	Form	Unchanged	Available
Form 85 Preliminary Audit Findings	Form	Unchanged	Repair queued
Form 84 Audit Schedule	Form	Unchanged	Available
Form 83 Waiver Assent Worksheet	Form	Unchanged	Available
Form 82 Board member application	Form	Unchanged	Available
Form 81 Elec Sig Page	Form	Unchanged	Available
Form 80 Site Prot DTL	Form	Unchanged	Available
Form 79 Protocol Specific DTL	Form	Unchanged	Available
Form 76 CTSU-OPEN Rave-Form	Form and Instruction	Modified	Available
Form 75 low accuring survey	Form	Unchanged	Available
Form 74 Prospective Survey	Form	Unchanged	Available
Form 73 Concept Survey	Form	Unchanged	Available
Form 72 PIO External Survey	Form	Unchanged	Available
Form 71 CIRB Board Member Annual Assessment	Form	Unchanged	Available
Form 66 CIRB FUP Survey	Form	Unchanged	Available
Form 65 CIRB Satisfaction survey	Form	Unchanged	Available
Form 64 OPEN survey	Form	Unchanged	Available
Form 61 Change PI Worksheet	Form	Unchanged	Available
Form 60 Unanticipated Problem Worksheet	Form and Instruction	Unchanged	Available
Form 59 Study Closure Transfer Worksheet	Form	Unchanged	Repair queued
Form 58 SSW Worksheet	Form and Instruction	Unchanged	Available
Form 57 Annual PI Worksheet	Form and Instruction	Unchanged	Repair queued
Form 56 Annual SI Worksheet	Form and Instruction	Unchanged	Available
Form 54 Reviewer Worksheet ER IR	Form and Instruction	Unchanged	Repair queued
Form 52 reviewer Worksheet ER ClosureWksht	Form and Instruction	Unchanged	Available
Form 51 Reviewer Worksheet Recruitment materials	Form and Instruction	Unchanged	Available
Form 50 Reviewer Worksheet Translated Docs	Form and Instruction	Unchanged	Available
Form 49 CIRB App for Translated Docs	Form and Instruction	Unchanged	Available
Form 48 Current CIRB Stat Reviewer Worksheet	Form	Unchanged	Available
Form 47 Reviewer Worksheet UP FB	Form and Instruction	Unchanged	Available
Form 45 ER SCRwksht CIRB-ReviewRegMods	Form	Unchanged	Available
Form 44 Ped FB SCRWksht	Form and Instruction	Unchanged	Available
Form 43 Adult & CPC FB SCRWksht	Form and Instruction	Unchanged	Available
Form 42 Ped Expedited CR Worksheet	Form and Instruction	Unchanged	Available
Form 41 Adult & CPC Expedited CR Worksheet	Form and Instruction	Unchanged	Available
Form 40 Ped Expedited Reviewer Worksheet	Form and Instruction	Unchanged	Available
Form 39 Adult & CPC Expedited Reviewer Worksheet	Form and Instruction	Unchanged	Available
Form 38 CPC FB Pharma Reviewer Worksheet	Form and Instruction	Unchanged	Available
Form 37 Adult Ped FB Pharma Adult Reviewer Worksheet	Form and Instruction	Unchanged	Available
Form 36 Ped AR FB Reviewer Worksheet	Form and Instruction	Unchanged	Available
Form 35 Adult AR FB Reviewer Worksheet	Form and Instruction	Unchanged	Available
Form 33 Adult CR FB Reviewer Worksheet	Form and Instruction	Unchanged	Available
Form 32 Ped IR FB Reviewerworksheet	Form and Instruction	Unchanged	Repair queued
Form 31 Adult IR FB Reviewer Worksheet	Form and Instruction	Unchanged	Repair queued
Form 30 CIRB CR Application	Form	Unchanged	Available
Form 29 CIRB Ancillary Application	Form and Instruction	Unchanged	Available
Form 28 CIRB AR Application	Form and Instruction	Unchanged	Available
Form 27 CIRB IR Exempt Application	Form and Instruction	Unchanged	Available
Form 26 CIRB IR Application	Form and Instruction	Unchanged	Available
Form 25 COI Screening	Form and Instruction	Unchanged	Available
Form 24 CIRB COI Update	Form	Unchanged	Repair queued
Form 19 NCI CIRB Signatory Enrollment Form	Form and Instruction	Unchanged	Repair queued
Form 18 NCI CIRB AA DivofResps	Form and Instruction	Unchanged	Available
Form 17 System Access Request Form	Form and Instruction	Unchanged	Available
Form 16 Transfer	Form and Instruction	Unchanged	Available
Form 15 patient Enrollment Transmittal Form	Form and Instruction	Unchanged	Repair queued
Form 12 Generic Data	Form and Instruction	Unchanged	Repair queued
Form 10 RTOG0834	Form and Instruction	Unchanged	Available
Form 9 Data Clarification Form	Form and Instruction	Unchanged	Available
Form 8 Site Data Update form	Form and Instruction	Unchanged	Available
Form 7 Supply	Form and Instruction	Unchanged	Repair queued
Form 6 Clinical Brochure	Form and Instruction	Unchanged	Available
Form 5 Roster Update	Form and Instruction	Unchanged	Available
Form 4 Site Addition	Form and Instruction	Unchanged	Available
Form 3 Withdrawal Form	Form and Instruction	Unchanged	Available
Form 2 IRB Certification	Form and Instruction	Unchanged	Available
Form 1 IRB Transmittal	Form and Instruction	Unchanged	Available
CTSU-OPEN-Rave-Form_RevisedMarks 7.19.19.docx	Supplementary Document	Uploaded 2019-08-14	Repair queued
CTEP Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-08-14	Repair queued
Attach1-Financial Disclosure-Revised Marks_CTEP v3.pdf	Supplementary Document	Uploaded 2019-07-01	Available
CTEP Change Request Memo 6.27.19 (1).docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-07-01	Available
Attachment_A17_csarf_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A16_transfer_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A15_ptentf_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A10_rtog0834_08202018_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A07_supply_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A06_clinbroch_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A05_ruf_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Repair queued
Attachment_A04_siteadd_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A03_wd_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
Attachment_A02_irbcrt_Tracked.pdf	Supplementary Document	Uploaded 2018-09-24	Available
ChangeRequestMemo_20180912_Clean.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-09-24	Available
SSB_CTEP Final.docx	Supporting Statement B	Uploaded 2018-04-30	Available
30-day FRN2018-08902.pdf	Supplementary Document	Uploaded 2018-04-30	Available
Attachment_F09_CTEPESYS_FIPS.pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
Attachment_F08_CTEPESYS_PIA.pdf	Supplementary Document	Uploaded 2018-04-30	Available
attachment_F07 - CIRB - Privacy Act Memo_10_2009.pdf	Supplementary Document	Uploaded 2018-04-30	Available
attachment_F06 - CIRB - Emmes IRB_exempt_09_2016 (1).pdf	Supplementary Document	Uploaded 2018-04-30	Available
attachment_F05 - CIRB - OHSR Determination.pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
attachment_F04 - CIRB_FIPS_199_09_2015.pdf	Supplementary Document	Uploaded 2018-04-30	Available
attachment_F03_privacy act memo.pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
attachment_F02_irb and OHSR determination.pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
attachment_F01_CTSU_PIA.pdf	Supplementary Document	Uploaded 2018-04-30	Available
SSA CTEP Support Contracts Forms and Surveys Final.docx	Supporting Statement A	Uploaded 2018-04-30	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
230005	NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)	Form and Instruction	Unchanged	Shipment Form (ASF)
230004	NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)	Form	Unchanged	Financial Disclosure
230004	NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)	Form	Unchanged	Fin Disclosure
230003	NCI/DCTD/CTEP Biosketch (Attachment E02)	Form and Instruction	Unchanged	Biosketch
230002	NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)	Form and Instruction	Unchanged	CTEP FDA Form 1572 for Annual Submission
230001	Final Report and CAPA Request Form (Attachment D07)	Form	Unchanged	Final Report CAPA Reg.
230000	Roster Maintenance Form (Attachment D06)	Form	Unchanged	Roster Maintenance
229999	Follow-up Form (Attachment D05)	Form	Unchanged	Follow up
229998	Final Audit Finding Report Form (Attachment D04)	Form	Unchanged	Final Audit Finding
229997	Audit Maintenance Form (Attachment D03)	Form	Unchanged	Aud Maint
229995	Preliminary Audit Findings Form (Attachment D02)	Form	Unchanged	Preliminary Audit Findings
229993	Audit Scheduling Form (Attachment D01)	Form	Unchanged	Audit Schedule
229991	Request Waiver of Assent Form (Attachment B46)	Form	Unchanged	Waiver Assent Worksheet
229989	CIRB Board Member Application (Attachment B3)	Form	Unchanged	Board member application
229988	CTSU PDF Signature Form (Attachment 21)	Form	Unchanged	Elec Sig Page
229986	CTSU Site Form Creation and PDF (Attachment A20)	Form	Unchanged	Site Prot DTL
229985	CTSU LPO Form Creation (Attachment A19)	Form	Unchanged	Protocol Specific DTL
229984	CTSU OPEN Rave Request Form (Attachment A18)	Form and Instruction	Modified	CTSU-OPEN Rave-Form
225929	Low Accural clinical Trial Survey (Attachment C11)	Form	Unchanged	low accuring survey
225928	Prospective Clinical Trial Survey (Attachment C10)	Form	Unchanged	Prospective Survey
225927	Concept Clinical Trial Survey (Attachment C9)	Form	Unchanged	Concept Survey
225926	PIO Customer Satisfaction Survey (Attachment C8)	Form	Unchanged	PIO External Survey
225925	CIRB Board member Annual Assessment Survey (Attachment C7)	Form	Unchanged	CIRB Board Member Annual Assessment
225923	Follow-up survey (Communication Audit) (Attachment C5)	Form	Unchanged	CIRB FUP Survey
225922	CIRB Customer Satisfaction survey (Attachment C4)	Form	Unchanged	CIRB Satisfaction survey
225921	CTSU OPEN Survey (Attachment C3)	Form	Unchanged	OPEN survey
225917	Change of SI PI Form (Attachment B45)	Form	Unchanged	Change PI Worksheet
225916	UP or SCN Reporting Form (Attachment B44)	Form and Instruction	Unchanged	Unanticipated Problem Worksheet
225915	Study Closure or Transfer of Study Review Responsibility Form (Attachment B43)	Form	Unchanged	Study Closure Transfer Worksheet
225914	Study-Specific worksheet About Local Context (Attachment B42)	Form and Instruction	Unchanged	SSW Worksheet
225913	Annual Principal Investigator Worksheet About Local Context (Attachment B41)	Form and Instruction	Unchanged	Annual PI Worksheet
225912	Annual signatory Institution Worksheet About Local Context (Attachment B40)	Form and Instruction	Unchanged	Annual SI Worksheet
225910	Reviewer Worksheet of Expedited IR (Attachment B38)	Form and Instruction	Unchanged	Reviewer Worksheet ER IR
225908	Reviewer worksheet Expedited Study Closure Review (Attachment B36)	Form and Instruction	Unchanged	reviewer Worksheet ER ClosureWksht
225907	Reviewer Worksheet of Recruitment Material (Attachment B35)	Form and Instruction	Unchanged	Reviewer Worksheet Recruitment materials
225906	Reviewer Worksheet of Translated Documents (Attachment B34)	Form and Instruction	Unchanged	Reviewer Worksheet Translated Docs
225904	CIRB Application for Translated Documents (Attachment B33)	Form and Instruction	Unchanged	CIRB App for Translated Docs
225903	Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32)	Form	Unchanged	Current CIRB Stat Reviewer Worksheet
225902	Reviewer Worksheet Determination of UP or SCN (Attachment B31)	Form and Instruction	Unchanged	Reviewer Worksheet UP FB
225900	Adult Expedited Study Chair Response to Required Mod (Attachment B29)	Form	Unchanged	ER SCRwksht CIRB-ReviewRegMods
225899	Pediatric Cooperative Group Response to CIRB Review (Attachment B28)	Form and Instruction	Unchanged	Ped FB SCRWksht
225898	Adult Cooperative Group Response to CIRB Review (Attachment B27)	Form and Instruction	Unchanged	Adult & CPC FB SCRWksht
225897	Pediatric Expedited Continuing Review (Attachment B26)	Form and Instruction	Unchanged	Ped Expedited CR Worksheet
225895	Adult Expedited Continuing Review (Attachment B25)	Form and Instruction	Unchanged	Adult & CPC Expedited CR Worksheet
225894	Pediatric Expedited Amendment Review (Attachment B24)	Form and Instruction	Unchanged	Ped Expedited Reviewer Worksheet
225893	Adult Expedited Amendment Review (Attachment B23)	Form and Instruction	Unchanged	Adult & CPC Expedited Reviewer Worksheet
225892	CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)	Form and Instruction	Unchanged	CPC FB Pharma Reviewer Worksheet
225891	Pharmacist's Review of a Cooperative Group Study (Attachment B21)	Form and Instruction	Unchanged	Adult Ped FB Pharma Adult Reviewer Worksheet
225890	Pediatric Amendment of Cooperative Group Protocol (Attachment B20)	Form and Instruction	Unchanged	Ped AR FB Reviewer Worksheet
225889	Adult amendment of Cooperative Group Protocol (Attachment B19)	Form and Instruction	Unchanged	Adult AR FB Reviewer Worksheet
225887	Adult Continuing Review of Cooperative Group Protocol (Attachment B17)	Form and Instruction	Unchanged	Adult CR FB Reviewer Worksheet
225886	Pediatric IR of Cooperative Group Protocol (Attachment B16)	Form and Instruction	Unchanged	Ped IR FB Reviewerworksheet
225885	Adult IR of cooperative Group Protocol (Attachment B15)	Form and Instruction	Unchanged	Adult IR FB Reviewer Worksheet
225884	CIRB Continuing Review Application (Attachment B14)	Form	Unchanged	CIRB CR Application
225883	CIRB Ancillary Studies Application (Attachment B13)	Form and Instruction	Unchanged	CIRB Ancillary Application
225882	CIRB Amendment Review Application (Attachment B12)	Form and Instruction	Unchanged	CIRB AR Application
225881	CIRB IR Application for Exempt Studies (Attachment B11)	Form and Instruction	Unchanged	CIRB IR Exempt Application
225880	CIRB IR Application (Attachment B10)	Form and Instruction	Unchanged	CIRB IR Application
225879	CIRB COI Screening for CIRB meetings (Attachment B9)	Form and Instruction	Unchanged	COI Screening
225878	CIRB Member COI Screening Worksheet (Attachment B8)	Form	Unchanged	CIRB COI Update
225873	NCI CIRB Signatory Enrollment Form (Attachment B2)	Form and Instruction	Unchanged	NCI CIRB Signatory Enrollment Form
225871	NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)	Form and Instruction	Unchanged	NCI CIRB AA DivofResps
225870	CTSU System Access Request Form (Attachment A17)	Form and Instruction	Unchanged	System Access Request Form
225868	CTSU Transfer Form (Attachment A16)	Form and Instruction	Unchanged	Transfer
225866	CTSU Patient Enrollment Transmittal Form (Attachment A15)	Form and Instruction	Unchanged	patient Enrollment Transmittal Form
225861	CTSU Generic Data transmittal form (Attachment A12)	Form and Instruction	Unchanged	Generic Data
225857	RTOG 0834 CTSU Data Transmittal Form (Attachment A10)	Form and Instruction	Unchanged	RTOG0834
225853	Data Clarification Form (Attachment A9)	Form and Instruction	Unchanged	Data Clarification Form
225852	Site Initated Data Update Form (Attachment A8)	Form and Instruction	Unchanged	Site Data Update form
225850	CTSU Supply Request Form (Attachment A7)	Form and Instruction	Unchanged	Supply
225847	CTSU Request for Clinical Brochure (Attachment A6)	Form and Instruction	Unchanged	Clinical Brochure
225846	CTSU Roster Update Form (Attachment A5)	Form and Instruction	Unchanged	Roster Update
225845	Site Addition Form (Attachment A4)	Form and Instruction	Unchanged	Site Addition
225844	Withdrawl from Protocol Participation Form (Attachment A3)	Form and Instruction	Unchanged	Withdrawal Form
225843	CTSU IRB Certification Form (Attachment A2)	Form and Instruction	Unchanged	IRB Certification
225841	CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)	Form and Instruction	Unchanged	IRB Transmittal

ICR Details

OMB Control No: 0925-0753	ICR Reference No: 201908-0925-003
Status: Historical Active	Previous ICR Reference No: 201906-0925-003
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: 08/28/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/15/2019
Terms of Clearance:

table that charts list comparision

	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

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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).

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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:
	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

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Number of Information Collection (IC) in this ICR: 75

table that charts list of burden

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)	76	CTSU-OPEN Rave-Form
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)	1, 93	Fin Disclosure ,   Financial 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

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ICR Summary of Burden

table that charts list 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:

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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

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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: 08/15/2019

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