In 2008 the US Food and Drug Administration (FDA) published Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. The guidance document is specifically intended to clarify the FDA’s expectations concerning the responsibilities of clinical research investigators and sponsors regarding the supervision of clinical studies in which some study tasks are delegated to investigator employees, colleagues, or third parties.
It is the objective of this article to briefly examine these responsibilities, with a specific focus on the delegation of authority, and to present methods clinical research organizations (CRO) can implement to effectively document the delegation of those responsibilities in compliance with FDA guidelines. The information presented in this article is based on the insight and experience of two professionals with considerable experience in the management and administration of clinical research studies.
A 22-year clinical research veteran, Nadine Nemunaitis is Vice President of Research Operations for the Texas-based Mary Crowley Cancer Research Centers. In that role she oversees the Human Research Protections Program within Mary Crowley’s central Institutional Review Board (IRB), as well as the division of research operations, which encompasses study development, project management, quality assurance, data management and site management. Throughout her professional career she has prepared for and represented principal investigators in the conduct of 12 FDA site audits, and has represented an institution central IRB in the conduct of 6 FDA IRB audits.
Nadine’s primary mandate is to apply her expertise and experience in carrying out Mary Crowley’s mission to expand treatment options for cancer patients. She is committed to ensuring this mission is achieved in compliance with federal regulations and national standards, state and local laws, as well as institutional policies.
Staci Horvath began working in clinical research 15 years ago in a regulatory affairs position. Four years later she moved into a clinical setting, working on National Insitute of Health-funded trials. While there was a small regulatory component involved, most of the experience gained in that position was patient-focused. Staci then had an opportunity to expand that experience by working again with FDA regulated studies in an advanced regulatory affairs role, while continuing to work with patients and gaining experience with contract budget negotiations and research finance accounting.
In those positions Staci gained an array of experience in site operations that led to a successful transition into a research operations management and project management position with Mary Standardizing Principal Investigation Delegation Records
Crowley Cancer Research Center, where Staci spent a number of years before entering her current position as the Mary Crowley’s Director of Operations. In this role she is responsible for ensuring the effective execution of projects in compliance with FDA regulations and good-practice guidelines from the International Conference on Harmonisation (ICH) and the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP).