CTEP Branch Support Contracts Forms and Surveys (NCI)

Forms and Documents

Document	Type	Status	Availability
Form 94 NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)	Form and Instruction	New	Repair queued
Form 93 NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)	Form	New	Repair queued
Form 92 NCI/DCTD/CTEP Biosketch (Attachment E02)	Form and Instruction	New	Available
Form 91 NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)	Form and Instruction	New	Repair queued
Form 90 Final Report and CAPA Request Form (Attachment D07)	Form	New	Repair queued
Form 89 Roster Maintenance Form (Attachment D06)	Form	New	Available
Form 88 Follow-up Form (Attachment D05)	Form	New	Repair queued
Form 87 Final Audit Finding Report Form (Attachment D04)	Form	New	Repair queued
Form 86 Audit Maintenance Form (Attachment D03)	Form	New	Repair queued
Form 85 Preliminary Audit Findings Form (Attachment D02)	Form	New	Repair queued
Form 84 Audit Scheduling Form (Attachment D01)	Form	New	Available
Form 83 Request Waiver of Assent Form (Attachment B46)	Form	New	Repair queued
Form 82 CIRB Board Member Application (Attachment B3)	Form	New	Repair queued
Form 81 CTSU PDF Signature Form (Attachment 21)	Form	New	Available
Form 80 CTSU Site Form Creation and PDF (Attachment A20)	Form	New	Available
Form 79 CTSU LPO Form Creation (Attachment A19)	Form	New	Repair queued
Form 78 CTSU OPEN Rave Request Form (Attachment A18)	Form	New	Repair queued
Form 77 ETCTN RS Survey (Attachment C13)	Form	Removed	Repair queued
Form 76 ETCTN PI Survey (Attachment C12)	Form	Removed	Repair queued
Form 75 Low Accural clinical Trial Survey (Attachment C11)	Form	Unchanged	Available
Form 74 Prospective Clinical Trial Survey (Attachment C10)	Form	Unchanged	Repair queued
Form 73 Concept Clinical Trial Survey (Attachment C9)	Form	Unchanged	Repair queued
Form 72 PIO Customer Satisfaction Survey (Attachment C8)	Form	Unchanged	Available
Form 71 CIRB Board member Annual Assessment Survey (Attachment C7)	Form	Modified	Repair queued
Form 67 Website Focus Groups, Communication Project (Attachments C6 A-D)	Form	Removed	Available
Form 66 Follow-up survey (Communication Audit) (Attachment C5)	Form	Unchanged	Repair queued
Form 65 CIRB Customer Satisfaction survey (Attachment C4)	Form	Unchanged	Repair queued
Form 64 CTSU OPEN Survey (Attachment C3)	Form	Unchanged	Repair queued
Form 63 CTSU Help Desk Customer Satisfaction Survey (Attachment C2)	Form and Instruction	Removed	Repair queued
Form 62 CTSU Website Customer Satisfaction Survey (Attachment C1)	Form	Removed	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	Available
Form 58 Study-Specific worksheet About Local Context (Attachment B42)	Form and Instruction	Unchanged	Available
Form 57 Annual Principal Investigator Worksheet About Local Context (Attachment B41)	Form and Instruction	Unchanged	Repair queued
Form 56 Annual signatory Institution Worksheet About Local Context (Attachment B40)	Form and Instruction	Unchanged	Repair queued
Form 55 Reviewer Worksheet CPC - Determination of UP or SCN (Attachment B39)	Form and Instruction	Removed	Repair queued
Form 54 Reviewer Worksheet of Expedited IR (Attachment B38)	Form and Instruction	Unchanged	Repair queued
Form 53 Reviewer Worksheet expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37)	Form and Instruction	Removed	Repair queued
Form 52 Reviewer worksheet Expedited Study Closure Review (Attachment B36)	Form and Instruction	Unchanged	Available
Form 51 Reviewer Worksheet of Recruitment Material (Attachment B35)	Form and Instruction	Unchanged	Available
Form 50 Reviewer Worksheet of Translated Documents (Attachment B34)	Form and Instruction	Unchanged	Available
Form 49 CIRB Application for Translated Documents (Attachment B33)	Form and Instruction	Unchanged	Repair queued
Form 48 Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32)	Form	Modified	Available
Form 47 Reviewer Worksheet Determination of UP or SCN (Attachment B31)	Form and Instruction	Modified	Available
Form 46 Pediatric Expedited Strudy Chair Response to Required Mod (Attachment B30)	Form and Instruction	Removed	Available
Form 45 Adult Expedited Study Chair Response to Required Mod (Attachment B29)	Form	Modified	Available
Form 44 Pediatric Cooperative Group Response to CIRB Review (Attachment B28)	Form and Instruction	Unchanged	Repair queued
Form 43 Adult Cooperative Group Response to CIRB Review (Attachment B27)	Form and Instruction	Unchanged	Available
Form 42 Pediatric Expedited Continuing Review (Attachment B26)	Form and Instruction	Unchanged	Repair queued
Form 41 Adult Expedited Continuing Review (Attachment B25)	Form and Instruction	Unchanged	Available
Form 40 Pediatric Expedited Amendment Review (Attachment B24)	Form and Instruction	Unchanged	Available
Form 39 Adult Expedited Amendment Review (Attachment B23)	Form and Instruction	Unchanged	Available
Form 38 CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)	Form and Instruction	Unchanged	Available
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	Unchanged	Available
Form 35 Adult amendment of Cooperative Group Protocol (Attachment B19)	Form and Instruction	Unchanged	Repair queued
Form 34 Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18)	Form and Instruction	Removed	Repair queued
Form 33 Adult Continuing Review of Cooperative Group Protocol (Attachment B17)	Form and Instruction	Unchanged	Repair queued
Form 32 Pediatric IR of Cooperative Group Protocol (Attachment B16)	Form and Instruction	Unchanged	Repair queued
Form 31 Adult IR of cooperative Group Protocol (Attachment B15)	Form and Instruction	Unchanged	Repair queued
Form 30 CIRB Continuing Review Application (Attachment B14)	Form	Modified	Repair queued
Form 29 CIRB Ancillary Studies Application (Attachment B13)	Form and Instruction	Unchanged	Repair queued
Form 28 CIRB Amendment Review Application (Attachment B12)	Form and Instruction	Unchanged	Repair queued
Form 27 CIRB IR Application for Exempt Studies (Attachment B11)	Form and Instruction	Unchanged	Repair queued
Form 26 CIRB IR Application (Attachment B10)	Form and Instruction	Unchanged	Available
Form 25 CIRB COI Screening for CIRB meetings (Attachment B9)	Form and Instruction	Unchanged	Available
Form 24 CIRB Member COI Screening Worksheet (Attachment B8)	Form	Modified	Repair queued
Form 23 CIRB Direct Deposit Form (Attachment B7)	Form	Removed	Repair queued
Form 22 CIRB Board Member NDA (Attachment B6)	Form and Instruction	Removed	Repair queued
Form 21 CIRB Board member Contact Information Form (Attachment B4)	Form and Instruction	Removed	Repair queued
Form 20 CIRB Board member Biographical Sketch (Attachment B3)	Form and Instruction	Removed	Available
Form 19 NCI CIRB Signatory Enrollment Form (Attachment B2)	Form and Instruction	Unchanged	Repair queued
Form 18 NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)	Form and Instruction	Unchanged	Available
Form 14 Uncolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment A14)	Form and Instruction	Removed	Repair queued
Form 13 TAILORx_PACCT1_Data Transmittal Form (Attachment A13)	Form and Instruction	Removed	Repair queued
Form 12 CTSU Generic Data transmittal form (Attachment A12)	Form and Instruction	Unchanged	Repair queued
Form 11 MC0845 (8233) CTSU Data Transmittal Form (Attachment A11)	Form and Instruction	Removed	Repair queued
Form 9 Data Clarification Form (Attachment A9)	Form and Instruction	Unchanged	Repair queued
Form 8 Site Initated Data Update Form (Attachment A8)	Form and Instruction	Unchanged	Repair queued
Form 1 CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)	Form and Instruction	Unchanged	Available
SSB_CTEP Final.docx	Supporting Statement B	Uploaded 2018-04-30	Repair queued
30-day FRN2018-08902.pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
Attachment_F09_CTEPESYS_FIPS.pdf	Supplementary Document	Uploaded 2018-04-30	Available
Attachment_F08_CTEPESYS_PIA.pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
attachment_F07 - CIRB - Privacy Act Memo_10_2009.pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
attachment_F06 - CIRB - Emmes IRB_exempt_09_2016 (1).pdf	Supplementary Document	Uploaded 2018-04-30	Repair queued
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	Repair queued
SSA CTEP Support Contracts Forms and Surveys Final.docx	Supporting Statement A	Uploaded 2018-04-30	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
230005	NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)	Form and Instruction	New
230004	NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)	Form	New
230003	NCI/DCTD/CTEP Biosketch (Attachment E02)	Form and Instruction	New
230002	NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)	Form and Instruction	New
230001	Final Report and CAPA Request Form (Attachment D07)	Form	New
230000	Roster Maintenance Form (Attachment D06)	Form	New
229999	Follow-up Form (Attachment D05)	Form	New
229998	Final Audit Finding Report Form (Attachment D04)	Form	New
229997	Audit Maintenance Form (Attachment D03)	Form	New
229995	Preliminary Audit Findings Form (Attachment D02)	Form	New
229993	Audit Scheduling Form (Attachment D01)	Form	New
229991	Request Waiver of Assent Form (Attachment B46)	Form	New
229989	CIRB Board Member Application (Attachment B3)	Form	New
229988	CTSU PDF Signature Form (Attachment 21)	Form	New
229986	CTSU Site Form Creation and PDF (Attachment A20)	Form	New
229985	CTSU LPO Form Creation (Attachment A19)	Form	New
229984	CTSU OPEN Rave Request Form (Attachment A18)	Form	New
225931	ETCTN RS Survey (Attachment C13)	Form	Removed
225930	ETCTN PI Survey (Attachment C12)	Form	Removed
225929	Low Accural clinical Trial Survey (Attachment C11)	Form	Unchanged
225928	Prospective Clinical Trial Survey (Attachment C10)	Form	Unchanged
225927	Concept Clinical Trial Survey (Attachment C9)	Form	Unchanged
225926	PIO Customer Satisfaction Survey (Attachment C8)	Form	Unchanged
225925	CIRB Board member Annual Assessment Survey (Attachment C7)	Form	Modified
225924	Website Focus Groups, Communication Project (Attachments C6 A-D)	Form	Removed
225923	Follow-up survey (Communication Audit) (Attachment C5)	Form	Unchanged
225922	CIRB Customer Satisfaction survey (Attachment C4)	Form	Unchanged
225921	CTSU OPEN Survey (Attachment C3)	Form	Unchanged
225919	CTSU Help Desk Customer Satisfaction Survey (Attachment C2)	Form and Instruction	Removed
225918	CTSU Website Customer Satisfaction Survey (Attachment C1)	Form	Removed
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	Unchanged
225913	Annual Principal Investigator Worksheet About Local Context (Attachment B41)	Form and Instruction	Unchanged
225912	Annual signatory Institution Worksheet About Local Context (Attachment B40)	Form and Instruction	Unchanged
225911	Reviewer Worksheet CPC - Determination of UP or SCN (Attachment B39)	Form and Instruction	Removed
225910	Reviewer Worksheet of Expedited IR (Attachment B38)	Form and Instruction	Unchanged
225909	Reviewer Worksheet expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37)	Form and Instruction	Removed
225908	Reviewer worksheet Expedited Study Closure Review (Attachment B36)	Form and Instruction	Unchanged
225907	Reviewer Worksheet of Recruitment Material (Attachment B35)	Form and Instruction	Unchanged
225906	Reviewer Worksheet of Translated Documents (Attachment B34)	Form and Instruction	Unchanged
225904	CIRB Application for Translated Documents (Attachment B33)	Form and Instruction	Unchanged
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
225901	Pediatric Expedited Strudy Chair Response to Required Mod (Attachment B30)	Form and Instruction	Removed
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	Unchanged
225898	Adult Cooperative Group Response to CIRB Review (Attachment B27)	Form and Instruction	Unchanged
225897	Pediatric Expedited Continuing Review (Attachment B26)	Form and Instruction	Unchanged
225895	Adult Expedited Continuing Review (Attachment B25)	Form and Instruction	Unchanged
225894	Pediatric Expedited Amendment Review (Attachment B24)	Form and Instruction	Unchanged
225893	Adult Expedited Amendment Review (Attachment B23)	Form and Instruction	Unchanged
225892	CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)	Form and Instruction	Unchanged
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	Unchanged
225889	Adult amendment of Cooperative Group Protocol (Attachment B19)	Form and Instruction	Unchanged
225888	Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18)	Form and Instruction	Removed
225887	Adult Continuing Review of Cooperative Group Protocol (Attachment B17)	Form and Instruction	Unchanged
225886	Pediatric IR of Cooperative Group Protocol (Attachment B16)	Form and Instruction	Unchanged
225885	Adult IR of cooperative Group Protocol (Attachment B15)	Form and Instruction	Unchanged
225884	CIRB Continuing Review Application (Attachment B14)	Form	Modified
225883	CIRB Ancillary Studies Application (Attachment B13)	Form and Instruction	Unchanged
225882	CIRB Amendment Review Application (Attachment B12)	Form and Instruction	Unchanged
225881	CIRB IR Application for Exempt Studies (Attachment B11)	Form and Instruction	Unchanged
225880	CIRB IR Application (Attachment B10)	Form and Instruction	Unchanged
225879	CIRB COI Screening for CIRB meetings (Attachment B9)	Form and Instruction	Unchanged
225878	CIRB Member COI Screening Worksheet (Attachment B8)	Form	Modified
225877	CIRB Direct Deposit Form (Attachment B7)	Form	Removed
225876	CIRB Board Member NDA (Attachment B6)	Form and Instruction	Removed
225875	CIRB Board member Contact Information Form (Attachment B4)	Form and Instruction	Removed
225874	CIRB Board member Biographical Sketch (Attachment B3)	Form and Instruction	Removed
225873	NCI CIRB Signatory Enrollment Form (Attachment B2)	Form and Instruction	Unchanged
225871	NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1)	Form and Instruction	Unchanged
225870	CTSU System Access Request Form (Attachment A17)		Unchanged
225868	CTSU Transfer Form (Attachment A16)		Unchanged
225866	CTSU Patient Enrollment Transmittal Form (Attachment A15)		Unchanged
225863	Uncolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment A14)	Form and Instruction	Removed
225862	TAILORx_PACCT1_Data Transmittal Form (Attachment A13)	Form and Instruction	Removed
225861	CTSU Generic Data transmittal form (Attachment A12)	Form and Instruction	Unchanged
225860	MC0845 (8233) CTSU Data Transmittal Form (Attachment A11)	Form and Instruction	Removed
225857	RTOG 0834 CTSU Data Transmittal Form (Attachment A10)		Unchanged
225853	Data Clarification Form (Attachment A9)	Form and Instruction	Unchanged
225852	Site Initated Data Update Form (Attachment A8)	Form and Instruction	Unchanged
225850	CTSU Supply Request Form (Attachment A7)		Unchanged
225847	CTSU Request for Clinical Brochure (Attachment A6)		Unchanged
225846	CTSU Roster Update Form (Attachment A5)		Unchanged
225845	Site Addition Form (Attachment A4)		Unchanged
225844	Withdrawl from Protocol Participation Form (Attachment A3)		Unchanged
225843	CTSU IRB Certification Form (Attachment A2)		Unchanged
225841	CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0925-0753	ICR Reference No: 201802-0925-001
Status: Historical Active	Previous ICR Reference No: 201702-0925-003
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/31/2018
	Date Received in OIRA: 05/01/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2021	36 Months From Approved	06/30/2020
Responses	207,989	0	100,337
Time Burden (Hours)	112,838	0	15,524
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

IC Title	Form No.	Form Name
CTSU Request for Clinical Brochure (Attachment A6)	6
CTSU Supply Request Form (Attachment A7)	7
CTSU Transfer Form (Attachment A16)	16
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
Low Accural clinical Trial Survey (Attachment C11)	75	low accuring 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
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
CTSU Help Desk Customer Satisfaction Survey (Attachment C2)	63	Help Desk Survey
Website Focus Groups, Communication Project (Attachments C6 A-D)	69, 70, 67, 68	CIRB Website Focus Group Survey - CIRB Members usability ,   CIRB Website Focus Group Survey - Local Instiutions usability ,   CIRB Website Focus Group Survey - Network Groups usability ,   CIRB Website Focus Group Survey -Web site usability testing
ETCTN PI Survey (Attachment C12)	76	ETCTN PI Survey
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01)	91	CTEP FDA Form 1572 for Annual Submission
TAILORx_PACCT1_Data Transmittal Form (Attachment A13)	13	TAILORx PACCT1_DTF
MC0845 (8233) CTSU Data Transmittal Form (Attachment A11)	11	8233 Form
Uncolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment A14)	14	TAILORx UDM
CTSU OPEN Rave Request Form (Attachment A18)	78	CTSU OPEN RaveRegForm
CIRB Board member Biographical Sketch (Attachment B3)	20	CIRB Biosketch Questions CIRB member
CIRB Direct Deposit Form (Attachment B7)	23	CIRB Direct Deposit Form
ETCTN RS Survey (Attachment C13)	77	ETCTN
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 21)	81	Elec Sig Page
CIRB Board Member NDA (Attachment B6)	22	CIRB Member NDA
Pediatric Expedited Strudy Chair Response to Required Mod (Attachment B30)	46	Ped Exped Chair Resp Req Mods
Reviewer Worksheet CPC - Determination of UP or SCN (Attachment B39)	55	Reviewer Worksheet CPC UP FB
CTSU Website Customer Satisfaction Survey (Attachment C1)	62	websurvey final
Adult Expedited Study Chair Response to Required Mod (Attachment B29)	45	ER SCRwksht CIRB-ReviewRegMods
RTOG 0834 CTSU Data Transmittal Form (Attachment A10)	10
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)	93	Fin Disclosure
CIRB Board member Contact Information Form (Attachment B4)	21	CIRB ContactInfoForm
Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18)	34	Oed CR FB Reviewer Worksheet
CTSU Generic Data transmittal form (Attachment A12)	12	Generic Data
CTSU System Access Request Form (Attachment A17)	17
CIRB IR Application (Attachment B10)	26	CIRB IR Application
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22)	38	CPC FB Pharma Reviewer Worksheet
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
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
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
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
Data Clarification Form (Attachment A9)	9	Data Clarification Form
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
Site Addition Form (Attachment A4)	4
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)	1	IRB Transmittal
Withdrawl from Protocol Participation Form (Attachment A3)	3
Site Initated Data Update Form (Attachment A8)	8	Site Data Update form
Reviewer Worksheet expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37)	53	Reviewer Worksheet SCR ER
Request Waiver of Assent Form (Attachment B46)	83	Waiver Assent Worksheet
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
CTSU Patient Enrollment Transmittal Form (Attachment A15)	15
CTSU Roster Update Form (Attachment A5)	5

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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	100,337	0	107,652	0	0
Annual Time Burden (Hours)	112,838	15,524	0	97,314	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 adds data collection for the CTMB AIS and for the PMB RCR as well as form changes for the CTSU and CIRB. The burden from the previously approved submission was 15,524 and with these changes it has increased to 112,838. The net change is an increase of 97,314 hours. The CTMB AIS forms accounts for an additional 19,082 hours, and the PMB RCR forms for an additional 78,333 hours. The burden hours for the CTSU, CIRB and surveys slightly decreased to 15,524 hours.

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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: 05/01/2018

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