The Quality Assistance Review (QAR) is an educational program designed to provide support and guidance to investigators conducting human subject research studies at UPitt, which are not otherwise monitored by the ECS-HSR. The intent of this review is to be educational and offer suggestions for maintaining high-quality study documentation, protocol adherence, and fostering regulatory compliance with IRB-approved research protocols.
The QAR is a virtual meeting that lasts approximately 60 minutes and involves a brief discussion of the informed consent process as well as other topics including protocol eligibility, deviations, and data safety monitoring (DSM). This is a collaborative discussion and study teams are encouraged to ask questions and participate in the dialogue.
To facilitate the review, study teams are asked to create a secure OneDrive folder and upload the following documents:
- Signed consent document and consent process note for the three most recently enrolled subjects,
- Completed eligibility checklist for the most recently enrolled subject,
- Protocol deviation log,
- Past three months of internal DSM meetings minutes, and
- DSM board letter(s) for the past year.
The ECS-HSR is available to conduct QAR meetings upon request by contacting ECS-HSR@pitt.edu.