Proposal Audit and Review
The Proposal Audit and Review ensures that studies meet exacting standards for quality, recruitment methods, feasibility, safety, GCP, Good Laboratory Practice, and IRB.
Our Review Process
LINCATS’s novel Proposal Audit and Review (PAR) service reviews study proposals for recruitment methods, feasibility, safety, GCP, GLP, and IRB requirements.
The PAR Steering Committee oversees the process and makes final recommendations to the applicant based on the PAR reviews. Services of the three-reviewer PAR team include:
- Assessment of need and adequacy of the Data Safety Monitoring Plan
- Confirmation proposals include culturally germane procedures and strategies to enroll participants from LINCATS’ diverse communities
- Financial and staffing feasibility assessment
- Identification of operational roadblocks.
The PAR report is generated within one week of receiving the proposal and may suggest modifications to improve the project. Applicants can resubmit a modified protocol to the PAR for a final review.
Service Lead
Sharon Nachman, MD
Chief of Division of Pediatric Infectious Diseases, and Director of the Office of Clinical Trials
Phone: (631) 444-7692