Virginia Chapter: Keeping Studies Audit-Ready - Practical Regulatory Binder and Continuing Review Strategies Through Staff Transitions
Event Description:
The most common red flags auditors uncovers include staff performing tasks before they are formally delegated to or have been trained, protocol amendment training is missing, expired medical licenses or unsigned/undated CVs and key decisions via email or phone calls are missing.
The reality is the clinical trial becomes at risk when small documentation shortcuts, missing dates, and unfiled emails begin to pile up. Often organizations rely on one super organized person and if they leave, burn out or change roles, the tracking system collapses, leaving a wake of unified, untracked essential documents.
Join us to hear about strategies to manage ongoing review of your essential documents during the course of the trial and with staff changes.
Speaker:
Maggie Lindemuth, M.Ed, CCRP
Senior Program Lead - Clinical Research Training, Support, and Development
Virginia Commonwealth University
Stravitz-Sanyal Liver Institute
Learning Objectives:
- Identify key components of an effective regulatory binder system that supports ongoing compliance and audit readiness.
- Apply strategies for managing continuing review requirements proactively to prevent lapses in approval.
- Develop approaches to maintain regulatory continuity and documentation integrity during staff turnover or role transitions.
Registration Information:
- Chapter Member: $0
- ACRP Member: $15
- Non-Member: $75
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.