OMB control number

NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

OMB 0925-0625 · HHS/NIH.

OMB 0925-0625

Latest Forms, Documents, and Supporting Material

Document Name
Form 2B Authorization Agreement and Division of Responsibilities b/w NCI CIRB and Signatory Institution (Attach 2B) Form and Instruction
Form 6I Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I) Form and Instruction
Form 6V Reviewer Advertisement Checklist (Attach 6V) Form and Instruction
Form 6U Reviewer Worksheet of Translated Documents (Attach 6U) Form and Instruction
Form 6T Ped Expedited Study Chair Response to Required Mod (Attach 6T) Form and Instruction
Form 6S Adult Expedited Study Chair Response to Required Mod (Attach 6S) Form and Instruction
Form 6R Ped Expedited Study Closure (Attach 6R) Form and Instruction
Form 6Q Adult Expedited Study Closure (Attach 6Q) Form and Instruction
Form 6P Ped Expedited Continuing Review (Attach 6P) Form and Instruction
Form 6O Adult Expedited Continuing Review (Attach 6O) Form and Instruction
Form 6N Ped Expedited Amendment Review (Attach 6N) Form and Instruction
Form 6M Adult Expedited Amendment Review (Attach 6M) Form and Instruction
Form 6L Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L) Form and Instruction
Form 18 Application Request to Review Translated Documents (Attach 5F) Form and Instruction
Form 5E Locally-Developed Material Submission Form (Attach 5E) Form and Instruction
Form 2ZB Change of Signatory Institution PI Form (Attach 2ZB) Form and Instruction
Form 2ZA One Time Study Roll Over Worksheet (Attach 2ZA) Form and Instruction
Form 2Z Add or Remove Affiliate Institution (Attach 2Z) Form and Instruction
Form 2Y Add or Remove Component Institution (Attach 2Y) Form and Instruction
Form 2X Add or Remove Affiliate Institution Personnel (Attach 2X) Form and Instruction
Form 2W Add or Remove Signatory and /or Component Institution Personnel (Attach 2W) Form and Instruction
Form 2V Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V) Form and Instruction
Form 2U Study Closure or Transfer of Study Review Responsibility Form (Attach 2U) Form and Instruction
Form 2T Study-Specific Worksheet About Local Context (Atttach 2T) Form and Instruction
Form 2S Annual Principal Investigator Worksheet About Local Context (Attach 2S) Form and Instruction
Form 2I Investigator at Affiliate Institution without IRB (Attach 2I) Form and Instruction
Form 2R Annual Institutional Worksheet About Local Context (Attach 2R) Form and Instruction
Form 2K Institutional Contact for Signatory Institution (Attach 2K) Form and Instruction
Form 2J Research Staff at Affiliated Institution without an IRB (Attach 2J) Form and Instruction
Form 6K CIRB Statistical Reviewer Form (Attach 6K) Form and Instruction
Form 6J Pediatric Pharmacist's Review of a Cooperative Group Study (Attach 6J) Form and Instruction
Form 6D Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D) Form and Instruction
Form 6C Adult Continuing Review of Cooperative Group Protocol (Attach 6C) Form and Instruction
Form 6F Pediatric Amendment of Cooperative Group Protocol (Attach 6F) Form and Instruction
Form 6E Adult Amendment of Cooperative Group Protocol (Attach 6E) Form and Instruction
Form 6H Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H) Form and Instruction
Form 6G Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G) Form and Instruction
Form 6B Pediatric Initial Review of Cooperative Group Protocol (Attach 6B) Form and Instruction
Form 6A Adult Initial Review of Cooperative Group Protocol (Attach 6A) Form and Instruction
Form 5C Adult/Pediatric CIRB Application for Continuing Review (Attach 5C) Form and Instruction
Form 5D Summary of CIRB Application Revisions (Attach 5D) Form and Instruction
Form 5B Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B ) Form and Instruction
Form 5A NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A) Form and Instruction
Form 3E CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E) Form and Instruction
Form 4 Direct Deposit Form (Attach 4) Form and Instruction
Form 3D CIRB New Board Member W-9 (Attach 3D) Form and Instruction
Form 3C CIRB New Board Member Contact Information Form (Attach 3C) Form and Instruction
Form 3B CIRB New Board Member Biographical Sketch Form (Attach 3B) Form and Instruction
Form 2Q Study Review Responsibility Transfer Form (Attach 2Q) Form and Instruction
Form 2P Facilitated Review Acceptance Form (FRAF) (Attach 2P) Form and Instruction
Form 2A Request for 30-Day Access Form (Attach 2A) Form and Instruction
Form 2O Institution Affiliate Institution without an IRB (Attach 2O) Form and Instruction
Form 2N IRB at Affiliate Institution (Attach 2N) Form and Instruction
Form 2M Component Institution at Signatory Institution (Attach 2M) Form and Instruction
Form 2L IRB at Signatory Institution (Attach 2L) Form and Instruction
Form 2H Research Staff at Affiliate Institution (Attach 2H) Form and Instruction
Form 2G Investigator at Affiliate Institution (Attach 2G) Form and Instruction
Form 2F Research Staff at Signatory Institution (Attach 2F) Form and Instruction
Form 2E Investigator at Signatory Institution (Attach 2E) Form and Instruction
Form 2D IRB Staff at Signatory Institution's IRB (Attach 2D) Form and Instruction
Form 2C NCI CIRB Institution Enrollment Worksheet (Attach 2C) Form and Instruction
Form 1 CIRB Helpdesk Survey (Attach 1B) Form and Instruction
Change Request Memo_1-24-2014.docx Justification for No Material/Nonsubstantive Change
Authorization Agreement and Division of Responsibilities b/w NCI CIRB and Signatory Institution (Attach 2B) Form and Instruction
Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I) Form and Instruction
Reviewer Advertisement Checklist (Attach 6V) Form and Instruction
Reviewer Worksheet of Translated Documents (Attach 6U) Form and Instruction
Ped Expedited Study Chair Response to Required Mod (Attach 6T) Form and Instruction
Adult Expedited Study Chair Response to Required Mod (Attach 6S) Form and Instruction
Ped Expedited Study Closure (Attach 6R) Form and Instruction
Adult Expedited Study Closure (Attach 6Q) Form and Instruction
Ped Expedited Continuing Review (Attach 6P) Form and Instruction
Adult Expedited Continuing Review (Attach 6O) Form and Instruction
Ped Expedited Amendment Review (Attach 6N) Form and Instruction
Adult Expedited Amendment Review (Attach 6M) Form and Instruction
Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L) Form and Instruction
Application Request to Review Translated Documents (Attach 5F) Form and Instruction
Locally-Developed Material Submission Form (Attach 5E) Form and Instruction
Change of Signatory Institution PI Form (Attach 2ZB) Form and Instruction
One Time Study Roll Over Worksheet (Attach 2ZA) Form and Instruction
Add or Remove Affiliate Institution (Attach 2Z) Form and Instruction
Add or Remove Component Institution (Attach 2Y) Form and Instruction
Add or Remove Affiliate Institution Personnel (Attach 2X) Form and Instruction
Add or Remove Signatory and /or Component Institution Personnel (Attach 2W) Form and Instruction
Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V) Form and Instruction
Study Closure or Transfer of Study Review Responsibility Form (Attach 2U) Form and Instruction
Study-Specific Worksheet About Local Context (Atttach 2T) Form and Instruction
Annual Principal Investigator Worksheet About Local Context (Attach 2S) Form and Instruction
Investigator at Affiliate Institution without IRB (Attach 2I) Form and Instruction
Annual Institutional Worksheet About Local Context (Attach 2R) Form and Instruction
Institutional Contact for Signatory Institution (Attach 2K) Form and Instruction
Research Staff at Affiliated Institution without an IRB (Attach 2J) Form and Instruction
CIRB Statistical Reviewer Form (Attach 6K) Form and Instruction
Pediatric Pharmacist's Review of a Cooperative Group Study (Attach 6J) Form and Instruction
Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D) Form and Instruction
Adult Continuing Review of Cooperative Group Protocol (Attach 6C) Form and Instruction
Pediatric Amendment of Cooperative Group Protocol (Attach 6F) Form and Instruction
Adult Amendment of Cooperative Group Protocol (Attach 6E) Form and Instruction
Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H) Form and Instruction
Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G) Form and Instruction
Pediatric Initial Review of Cooperative Group Protocol (Attach 6B) Form and Instruction
Adult Initial Review of Cooperative Group Protocol (Attach 6A) Form and Instruction
Adult/Pediatric CIRB Application for Continuing Review (Attach 5C) Form and Instruction
Summary of CIRB Application Revisions (Attach 5D) Form and Instruction
Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B ) Form and Instruction
NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A) Form and Instruction
CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E) Form and Instruction
Direct Deposit Form (Attach 4) Form and Instruction
CIRB New Board Member W-9 (Attach 3D) Form and Instruction
CIRB New Board Member Contact Information Form (Attach 3C) Form and Instruction
CIRB New Board Member Biographical Sketch Form (Attach 3B) Form and Instruction
Study Review Responsibility Transfer Form (Attach 2Q) Form and Instruction
Facilitated Review Acceptance Form (FRAF) (Attach 2P) Form and Instruction
Request for 30-Day Access Form (Attach 2A) Form and Instruction
Institution Affiliate Institution without an IRB (Attach 2O) Form and Instruction
IRB at Affiliate Institution (Attach 2N) Form and Instruction
Component Institution at Signatory Institution (Attach 2M) Form and Instruction
IRB at Signatory Institution (Attach 2L) Form and Instruction
Research Staff at Affiliate Institution (Attach 2H) Form and Instruction
Investigator at Affiliate Institution (Attach 2G) Form and Instruction
Research Staff at Signatory Institution (Attach 2F) Form and Instruction
Investigator at Signatory Institution (Attach 2E) Form and Instruction
IRB Staff at Signatory Institution's IRB (Attach 2D) Form and Instruction
NCI CIRB Institution Enrollment Worksheet (Attach 2C) Form and Instruction
CIRB Helpdesk Survey (Attach 1B) Form and Instruction

All Historical Document Collections

201402-0925-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2014-02-14
201311-0925-004 Approved without change	Revision of a currently approved collection	2013-11-22
201106-0925-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2011-06-03
201012-0925-001 Approved without change	Existing collection in use without an OMB Control Number	2010-12-02