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University of Colorado Denver

 

Quality Assurance Reviews

Office of Regulatory Compliance


The intent of the quality assurance reviews conducted by this office is primarily educational. The reviewers are colleagues and peers, and the experience is meant to be informative while also working toward ensuring data integrity, subject safety, and regulatory compliance.

Not-For-Cause

During "not-for-cause" reviews, we will do our best to not interfere with your ongoing educational, research, or clinical activities. Depending on the type of study, the scope of the review can include:

  • For studies reviewed by the full IRB board: The review will last approximately a day and a half, and has two main components, interviews and meetings with study staff and document reviews.
  • For studies reviewed by the IRB via expedited review: The review will last approximately one half day, and has two main components, interviews and meetings with study staff and document reviews.
  • For exempt studies: The reviews consists of a checklist for the investigator to complete, about which study processes and documents are the focus.

 

For-Cause:

A "for-cause" quality assurance review can be conducted by this office. In the case of a for-cause review, the investigator and/or the study has been brought to the attention of this office, there is evidence for concern and, thus, a pointed review is warranted.

For-cause reviews can take up to several days and are much more in-depth than the scope of not-for-cause reviews mentioned above.

 
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