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Abstract: Delegation of Responsibilities- Guidance in Response to FDA Audits

Thursday, September 15, 2016 — Poster Session II

12:00 p.m. – 1:30 p.m.
FAES Terrace


  • JN Beeler
  • LB Hoopengardner
  • K Patterson
  • SM Simpson
  • S Vogel
  • J Pierson
  • B Baseler


According to ICH-GCP, E6 4.1.5 “The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.” However, this often proves more difficult to accomplish than it appears. Most cited in FDA warning letters regarding deficiencies in delegation of responsibilities is that they could not confirm that an investigator complied with CFR 312.60, ”an investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.” Deficiencies have been identified in key areas including but not limited to: unqualified people performing study tasks, people performing responsibilities for which they are not delegated, investigators failing to maintain an accurate list identifying staff and the responsibilities delegated, and staff not being trained to perform responsibilities. This poster aims to represent a concise compilation of many of the issues identified by the FDA during previous inspections along with comparable information identified by Office of Clinical Research Policy and Regulatory Operations (OCRPRO)/ Regulatory Compliance and Human Subjects Protections Program Clinical Trials Management to provide practical experience-based suggestions for resolving these issues.

Category: Research Support Services