PI: MIRB # (Office Entry):

Title:

Initial Project Submission Checklist

All Studies

  1. Research & Development Information System Project Data Sheet (VA form 10-1436) (Version Jan 1989)
  2. Abstract – please refer to the Abstract Guidelines Form– andemail to IRB Assistant
  3. Prospectus of Research Study (Version Aug 2015)
  4. Research Protocol Safety Survey(VA Form 10-0398)(Version Aug 2008)(safety submission must be sent electronically to or pre-review prior to submission of signed hard copy)
  5. Impact Estimation Worksheets, signed and dated (Pharmacy (V. 3/31/08), Pathology (V. 9/15), Radiology (V. 9/15))
  6. Research Data Inventory Tool (Version Jul 2017)
  7. Inclusion/Exclusion Criteria Checklist

Additional – Human Subjects

  1. Application for IRB Review(Version 9/1/2016)
  2. Application for IRB Review– Supplement (stored human biological material or DNA) (Version 7/13/2017)
  3. At least one of the below protocols must be submitted
  4. Investigator Initiated Protocol (Narrative) 5 copies of both i and ii, if applicable
  5. Narrative – For details on how to prepare a Narrative for an Investigator Initiated Study, please refer to the Guidelines for Narrative Description of Proposed Research Form.
  6. Narrative Summary (no longer than 3 pages) – A Narrative Summary is required if the Investigator Initiated Protocol(Narrative) is substantially longer than 3 pages
  7. Sponsor Master Protocol5 copies
  8. VA Research Consent Form (ICF)(VA Form 10-1086) (Version 4/13/2017)
  9. VA Research Consent Form (ICF)(VA Form 10-1086)– genetic (if applicable) (Version 4/13/2017)
  10. HIPAA Authorization Form(VA Form 10-10116)(Version Sept 2015)
  11. HIPAA Revocation Form(VA Form 10-0493)(Version Sept 2015)
  12. Patient Recruitment Material (intended to be seen or heard by potential subjects)
  13. For-Profit Tissue Banking Application (if applicable) (Version Aug 2017)
  14. Non-Profit Tissue Banking Application (if applicable) (Version Aug 2017)
  15. Investigational Drug Information Record (VA Form 10-9012) (one for each drug to be used on study, if applicable)
  16. Investigator’s Brochure(if applicable) 5 copies
  17. If requesting: Waiver of Documentation of Informed Consent Form(Version 3/2017)
  18. If requesting:Waiver of HIPAA Authorization Form(Version 3/2017)
  19. If requesting: Waiver or Alteration of the Informed Consent Process Form(Version 3/2017)
  20. If this is a Device Study: Complete the Investigator Device Plan/Device Information Form (Version 8/1/15)
  21. Proposed subject questionnaires/educational materials, subject instructions, etc.
  22. Research Service Data Use and Security Plan (Version 10/31/2008) (only if VASI is being sent off-site)
  23. Other

Templates of the documents above may be found at

*Prior to submission

Human studies – Contact HRPP Officer at x4931 to verify that all staff listed on the Prospectus of Research Study and the Application for IRB Review have met training/education requirements. Research Office Verification:

PI: MIRB #:

Title:

IRB Exempt Project Submission Checklist

1.IRB Exempt Eligibility Determination Form (Version 12/14/07)

2.Research & Development Information System Project Data Sheet (VA form 10-1436) (Version Jan 1989)

3.Abstract – please refer to the Abstract Guidelines Form – and email to IRB Assistant

4.Prospectus of Research Study(Version Aug 2015)

5.Research Data Inventory Tool (Version Jul 2017)

6.At least one of the below protocols must be submitted

  1. Investigator Initiated Protocol (Narrative) 5 copies of both i and ii, if applicable
  2. Narrative – For details on how to prepare a narrative for an investigator initiated study, please refer to the Guidelines for Narrative Description of Proposed Research form
  3. Narrative Summary (no longer than 3 pages) – A Narrative Summary is required if the Investigator Initiated Protocol (Narrative) is substantially longer than 3 pages
  4. Sponsor Master Protocol 5 copies

7.Research Protocol Safety Survey (VA Form 10-0398) (Version Aug 2008)(safety submission must be sent electronically to for pre-review prior to submission of signed hard copy)

8.Impact Estimation Worksheets, signed and dated (Pharmacy(V. 3/31/08), Pathology(V. 9/15), Radiology(V. 9/15))

9.If requesting: Waiver of Documentation of Informed Consent Form (Version 3/2017)

10.If requesting: Waiver of HIPAA Authorization Form (Version 3/2017)

11.If requesting: Waiver or Alteration of the Informed Consent Process Form (Version 3/2017)

12.Other (anything else the IRB would need to know about your study to conduct a thorough review)

Templates of the documents above may be found at

PI: MIRB #:

Title:

Continuing Review Project Submission Checklist

All Studies

  1. Research & Development Information System Project Data Sheet (VA form 10-1436) (Version Jan1989)
  2. Updated Abstract – please refer to the Abstract Guidelines Form – and email to IRB Assistant
  3. Research Protocol Safety Survey (VA Form 10-0398) (Version Aug 2008) (safety submission must be sent electronically to for pre-review prior to submission of signed hard copy)
  4. Status of Active Study Application (Version 9/1/2016)
  5. Copy of original Application for IRB Review
  6. Inclusion/Exclusion Criteria Checklist

Additional – Human Subjects

  1. Copy of signature pages of the ICF/HIPAA Forms and CPRS enrollment notes for subjects enrolled since the last review
  2. Investigator Initiated Protocol (Narrative) and/or Sponsor Master Protocol(most current) 3 copies
  3. VA Research Consent Form(VA Form 10-1086) –(currently approved stamped version) only if still consenting or required by sponsor to have an active ICF
  4. VA Research Consent Form(VA Form 10-1086)– unstamped – (Version 4/13/17) only if still consenting or required by sponsor to have an active ICF
  5. HIPAA Authorization Form (currently approved stamped version) only if still consenting or required by sponsor to have active ICF
  6. HIPAA Revocation Form (currently approved stamped version) only if still consenting or required by sponsor to have an active ICF
  7. HIPAA Authorization Form – unstamped –(Version Sept 2015) only if still consenting or required by sponsor to have an active ICF
  8. HIPAA Revocation Form –unstamped – (Version Sept 2015) only if still consenting or required by sponsor to have an active ICF
  9. External Study Monitor Visit Reports and Follow-up Memos
  10. Any adverse event reports from investigators, sponsor safety reports (e.g., IND or IDE), MedWatch reports, and DSMB reports not previously submitted
  11. Any newly proposed consent documents/HIPAA documents/advertisements
  12. Any recruitment documents or advertisements for which you are seeking approval or re-approval (for re-approvals, please submit stamped and unstamped versions)
  13. Completed Request for Modification of Approved Project Form (Version 6/1/2015) for any changes to the protocol, consent or other documents that are being proposed at this time
  14. Documentation of protocol violations and/or deviations, unanticipated problems or non-compliance with applicable regulations that have not been previously submitted
  15. Updated Research Service Data Use and Security Plan (if applicable) (Version 10/31/2008)
  16. Other

Templates of the documents above may be found at

*Prior to submission

Human studies – Contact HRPP Officer at x4931 to verify that all staff listed on the Prospectus of Research Study and the Application for IRB Review have met training/education requirements. Research Office Verification:

PI: MIRB #:

Title:

Modification Submission Checklist

Human Studies Protocols

  1. Request for Modification of Approved Project Form (Version 6/01/2015)
  2. Copy of theInvestigator Initiated Protocol (Narrative) and/or Sponsor Master Protocol, if modified 3 copies
  3. A summary of protocol modifications
  4. If the ICF has been modified, submit a copy of the currently approved (stamped) form, a copy of modified form with the changes marked, plus an unmarked copy (Version 4/13/2017) for stamping
  5. Other documents:

Templates of the documents above may be found at

For Office Use Only:

Verification of training and credentialing of listed staff.

PI: MIRB # (Office Entry):

Title:

Central IRB Initial Study Submission Checklist

For All CIRB Studies – documents needed for VALBHS R&D review:

  1. Research & Development Information System Project Data Sheet (VA form 10-1436) (Version Jan 1989)
  2. Abstract – please refer to the Abstract Guidelines Form – and email to IRB Assistant
  3. Prospectus of Research Study (Version Aug 2015)
  4. Research Protocol Safety Survey (VA Form 10-0398)(Version Aug 2008)(safety submission must be sent electronically to or pre-review prior to submission of signed hard copy)
  5. Impact Estimation Worksheets, signed and dated (Pharmacy (V. 3/31/08), Pathology (V. 9/15), RadiologyV. 9/15))
  6. Copy of CIRB Local Site application
  7. Scope of Practice (for staff who have not previously completed)
  8. Training Certificates (for staff who have not previously completed)
  9. Other

Continuing Review Central IRB Project Submission Checklist

For All CIRB Studies seeking continuing revew – documents needed for VALBHS R&D review:

  1. Research & Development Information System Project Data Sheet (VA form 10-1436) (Version Jan 1989)
  2. UpdatedAbstract – please refer to the Abstract Guidelines Form – and email to IRB Assistant
  3. Research Protocol Safety Survey(VA Form 10-0398) (Version Aug 2008)(safety submission must be sent electronically to for pre-review prior to submission of signed hard copy)
  1. Copy of CIRB Continuing Review submission
  1. Listing of currently approved study staff (including PI, co-investigators and other staff):

Templates of the documents above may be found at

*Prior to submission

Human studies – Contact R&D Coordinator at x4948 to verify that all staff listed on the Prospectus of Research Study and the Application for IRB Review have met training/education requirements. Research Office Verification:

PI: MIRB #:

Title:

Closure Submission Checklist

Human Studies Protocols

  1. Research & Development Information System Project Data Sheet (VA form 10-1436) (Version Jan 1989)
  2. Updated Abstract – please refer to the Abstract Guidelines Form – and email to IRB Assistant
  3. Status of Active Study Application(Version 9/1/2016), marking “closure” on question #1a
  4. Copy of signature pages of ICF/HIPAA formsand CPRS enrollment notes for subjects enrolled since last review
  5. Other (including publications, etc.)

Templates of the documents above may be found at

Version: 8/2017

Prior versions are obsolete