Documents Required for IRB Review

 

DocumentInitial ReviewAmendmentContinuing Review(If Required)
UAPStudy Closure
Cover LetterOptionalOptionalOptionalOptionalOptional
COMIRB Application AllIf amendedAll  
COMIRB Form
 Change form
Continuing Review FormUnanticipated Problem FormContinuing Review Form
PI Attestation/Mentor AgreementAll AllAllAll
Tracked changes version of COMIRB Application and Attachments If amended   
ProtocolFull, Expedited, Secondary ResearchIf amendedFull, Expedited, Secondary Research  
Tracked changes version of protocol If amended   
Clean copy of: Consent forms/Assent FormsFull and ExpeditedIf amendedFull 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 AFull and ExpeditedIf amended   
HIPAA BFull and ExpeditedIf amendedVA Research  
Grant ApplicationIf primary recipientIf new or amendedIf new funding  
Surveys/Questionnaires/Interview or focus group guides/DiariesAll, if applicableIf amended   
Clean copy of: Information sheets/Verbal consent scriptsFull and ExpeditedIf amendedIf applicable  
Institutional approvals: VA Clearance Ltr., Denver Health SPARO Acknowledgement Ltr., HS Portal Approval Ltr., CHCO Start-Up Approval Lrt., etc.AllIf new or amended   
IRB Approvals from other sites (if UCD or affiliate is the lead site)If applicableIf amendedIf applicable  
Data collection tools, sheets or formsIf applicableIf amended   
Recruitment materials (e.g. advertisements, invitations, solicitations)If applicableIf amended   
Documentation of IND or IDE number (if appropriate)Full BoardIf amended   
Investigator's Brochure (for investigational drugs or devices)Full BoardIf amended If amended 
Product labeling (if studying an approved drug or device)Full and ExpeditedIf amended   
Conflict of interest management plan (if applicable)Full BoardIf new or amendedFull Board  
DSMB/DMC CharterFull Board    
DSMB/DMC ReportsIf applicableIf applicableIf applicableIf applicableIf applicable
Other safety reports or multicenter trial updatesIf applicableIf applicableIf applicableIf applicableIf applicable
Summary of pertinent recent literature/changes in the field If applicableIf applicableIf applicableIf 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