The Spectrum Health IRB is responsible for ensuring compliance with organizational policy, federal requirements and the ethical principles of the Belmont Report. As part of this responsibility, the IRB is expected to provide for post-approval monitoring of research. This Review is designed to meet this requirement through a pro-active and collaborative process with investigators.
The purpose of the Review is to provide information to investigators and staff on regulatory compliance and Good Clinical Practice (GCP) Guidelines related to human research participants, data collection and data management; to verify that safeguards protecting the rights and welfare of human research participants are met; to verify investigator adherence to the study design in the IRB-approved protocol, and applicable regulatory requirements; and rarely, to investigate complaints and/or allegations of noncompliance with research regulations. The review is meant to be a collaborative process whereby the on site reviewers assess compliance (regulatory, policy, approved protocol, etc.) and helps the investigator resolve/correct problems and discrepancies and provides recommendations for process improvements.
What does S.A.F.E. stand for?The S.A.F.E Program stands for “Stop, Assess, provide Feedback, Evaluate”.
What does an S.A.F.E On-Site Review entail?The Review will entail a visit to your site. The full Review usually takes an entire day on-site; however, this may vary depending on the complexity of the study and the enrollment. It is usually a good idea for the PI and/or study coordinator to be there in the morning before the visit begins and at the end of the day when the review is over. The PI does not need to be present for the entire review. However, a staff member should be available to provide the reviewer with the necessary documents, files and binders and answer any questions (or to contact the PI if there is an urgent question).
During the site visit, what will the reviewer examine?The scope of the review or investigation may vary depending on a number of factors, including if the review is random or for cause. All site reviews or investigations will be preceded by a notification letter from the Office of the IRB that includes specific details about the precise Scope of Review. The Scope of Review may include some, or all of the following items:
- The reviewer will be looking to see documentation that the approved protocol and study procedures are being followed by the research team.
- The review team will want to see all study related documents including:
- original signed informed consent forms
- subject files
- inclusion/exclusion checklists
- experimental drug/device accountability
- Adverse Events/Serious Adverse Events
- regulatory files (GCP Essential Documents) such as IRB files and correspondence, sponsor correspondence
- FDA files and related documents (if applicable)
- enrollment logs
- staff signature logs (delegation of responsibility logs)
- laboratory certifications and normal reference ranges
- Investigator Brochure