Committee Start-up & Support
HRP Consulting can provide guidance or hands-on assistance with the development, implementation, and ongoing support of research oversight committees, including IRB, IACUC, Conflict of Interest (COI) Review, and others. The successful implementation of such committees is more complex than most appreciate at first glance, HRP can help with the following and more:
- Member composition and documentation
- Federal registrations, when applicable
- Standard Operating Procedures, forms, checklists, and resources
- Electronic system implementation
- Chair, member, staff, and investigator training
- Temporary staff
- Retainers for on-call guidance and support
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...