Skip to main content
Sign In
 

Documents Required for IRB Review

Colorado Multiple Institutional Review Board


Document Initial Review Amendment Continuing Review UAP Study Closure
Cover letter All Optional Optional Optional All
COMIRB Application and relevant Attachments All If amended All
Tracked changes version of COMIRB Application and Attachments If amended
Protocol Full and Expedited If amended Full and Expedited
Tracked changes version of protocol If amended
Clean copy of: Consent forms/Assent Forms Full and Expedited If amended Full and Expedited
Tracked changes version of: Consent forms/Assent Forms/Information sheets/Verbal consent scripts If amended
"Stamped" copy of Consent forms/Assent Forms Full and Expedited
HIPAA A Full and Expedited If amended
HIPAA B Full and Expedited If amended VA Research
Grant application If primary recipient If new or amended If new funding
Surveys/Questionnaires/Interview or focus group guides/Diaries All, if applicable If amended
Clean copy of: Information sheets/Verbal consent scripts Full and Expedited If amended
Institutional approvals: VA Clearance Ltr., Denver Health Acknowledgement Ltr., HS Portal approval ltr., other support ltrs. All If new or amended
IRB Approvals from other sites (if UCD or affiliate is the lead site) If applicable If amended If applicable
Data collection tools, sheets or forms If applicable If amended
Recruitment materials (e.g.advertisements, invitations, solicitations) If applicable If amended
Documentation of IND or IDE number (if appropriate) Full Board If amended
Investigator's Brochure (for investigational drugs or devices) Full Board If amended If amended
Product labelling (if studying an approved drug or device) Full and Expedited If amended
Copy of FDA 1572 (for FDA‐regulated studies with an IND) Full Board
Conflict of interest management plan (if applicable) Full Board If new/amended
DSMB/DMC Charter Full Board
DSMB/DMC Reports If applicable If applicable If applicable If applicable If applicable
Other safety reports or multicenter trial updates If applicable If applicable If applicable If applicable If applicable
Summary of pertinent recent literature/changes in the field If applicable If applicable If applicable If applicable
Copies of any abstracts or publications from the research If applicable If applicable
Summary table(s) of protocol deviations/violations, and/or adverse events, since last continuing review and did not require prior reporting If applicable If applicable

Note: Additional documents may be requested during the course of IRB review.​​​