You open your email one morning to find a message from ORRP’s quality improvement staff that says your study has been selected for a post-approval monitoring check. What does that mean? Did you do something wrong?
Never fear! In this edition of Five Questions, Quality Improvement Specialist Meliha Rahmani breaks down post-approval monitoring: what it is, why we do it, and what it means for your research.
1. What is post-approval monitoring and why do you do it?
Post-approval monitoring (PAM) is a study review initiative that ORRP has implemented. Every fiscal year ORRP selects a subset of approved studies to review. PAM includes but is not limited to review of recruitment practices, screening, eligibility, informed consent, document storage, and privacy and confidentiality. The goal is to identify if a study is functioning as approved by the IRB. If PAM reveals it is not, the investigator/research team is notified, and the required corrections are made going forward.
Post-approval monitoring is part of the Quality Improvement program here at ORRP and is required for our human research protection program’s (HRPP) accreditation.
2. How are studies selected for PAM? Does being selected mean the investigator did something wrong or is in trouble?
Selection for PAM is random: we use the Excel randomization function to select active studies to review.
These are not-for-cause reviews and do not indicate any wrongdoing or concern. The goal is for this to be an educational initiative and to confirm the study is functioning as approved.
3. What are the most common errors observed in recent PAM assessments?
Common errors include:
- Consent documentation errors, including consenting an individual on the wrong version of a consent form or incomplete signature pages
- Study staff updates, for example, when study staff have left the university and need to be removed or when individuals conduct research activities before being added to the study team
- Inconsistencies between the Buck-IRB application and actual practice, such as when recruitment methods differ in actual practice from disclosure in Buck-IRB, or when the data storage/security actual practices differ from the description in Buck-IRB
4. What can researchers do to prepare for a PAM visit? What happens afterward?
Post-approval monitoring is an opportunity to get a fresh set of eyes to look at study records. If an inconsistency is detected it can be corrected early on, or if the study is complete, it can be an educational opportunity for future studies. A PAM request is a good prompt for study teams to get the study documents organized, to review informed consent forms, and to do a quick review of practices. Often the study team will self-identify any issues once the PAM review has been requested.
The close out of the PAM is a letter acknowledging the review and educational notes, as well as a note if items require an amendment or event report. If the PAM review requires action items, these should be submitted in a prompt matter.
5. How long have you done PAM in this role? What do you like about it?
I have 15+ years of research experience. I have been facilitating the post-approval monitoring program at ORRP for just about seven years and was working prior to this in an auditing role. We have found often researchers don’t have time to self-audit, and this gives them a moment to pause and reflect on processes and procedures. I enjoy the educational nature of post-approval monitoring.
Meliha Rahmani, a Certified Clinical Research Coordinator (CCRC) and Certified IRB Professional (CIP), supports quality improvement activities related to regulations and amendment review for Ohio State’s human subjects protections program. She can be reached at rahmani.3@osu.edu or 614-292-9625.