805: Arranging for a Quality Review of Research Team Files and Activities
Written notification of pending review will be sent from the Quality Improvement (QI) Officer. It is the responsibility of the QI Officer to schedule the visit after notice has been sent.
The following is an estimate of the timeframe for notification depending on the type of review being employed:
1. Random reviews will be scheduled in advance in conjunction with the researchers.
2. Directed reviews may be scheduled with 24 hour notice or without notice, if there is concern for safety of human subjects.
3. Informed consent reviews may be scheduled by mutual convenience since it involves observing the consent process.