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Colorado Multiple Institutional Review Board

Where to Begin as a Researcher?

Please see the "How To's of COMIRB" page for instructions on submitting many of the documents and forms required for Human Subject Research.

See the Policy & Procedures page for instructions detailing investigator responsibilities and the complete COMIRB Policy and Procedures document

What if I want to enroll in a Study?
Please see the Research Subject Information page if you are intested in being a participant in a study.

Policies and Procedures

 

COMIRB Policy and Procedure Document
  Complete COMIRB Policies and Procedures. 116 Page Adobe PDF document. Fully bookmarked and searchable.
Investigator Responsibilities
  Document describing the responsibilities of investigators for conducting human research and communicating with the IRB. (3 pages)
UCD Clinical Trials Fiscal Policy
  Primarily for those responsible for the fiscal management of Clinical Trials. (9 pages)
UCD Human Research Protection Plan Policies and Procedures
  Similar in scope to the COMIRB Policy and Procedures document above, however does not detail specific IRB procedures. This document encompasses the entire University of Colorado Denver institution. (29 pages)
UCD Guidance on Requirements of Sponsors
  UCD Guidance on Requirements of the Sponsor and the Investigator as a Sponsor
FDA Compliance Guidance
  FDA Guidance Document on Protecting the Rights and Welfare of Subjects.