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.
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:
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.
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.
exempt studies: The reviews consists of a checklist for the investigator to
complete, about which study processes and documents are the focus.
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.
reviews can take up to several days and are much more in-depth than the scope
of not-for-cause reviews mentioned above.