FDA Issues Draft Guidance Clarifying Clinical Study Investigator Responsibilities

On May 10, 2007, FDA announced the availability of a draft guidance for industry –“Protecting the Rights, Safety, and Welfare of Study Subjects – Supervisory Responsibilities of Investigators.”  The draft guidance document is intended to help investigators meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations, and clarifies FDA’s expectations concerning the investigator’s responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties. 

Under FDA’s Investigational New Drug and Investigational Device Exemption regulations, clinical study investigators have significant responsibilities. They are responsible for ensuring that a clinical investigation is conducted according to the signed investigator statement, the investigational plan, and for protecting the rights, safety, and welfare of study subjects under the investigator’s care.

In assessing the adequacy of supervision by a study investigator, FDA’s draft guidance focuses on four major points:  (1) whether there is appropriate delegation of study-related tasks; (2) whether study staff received adequate training; (3) whether there was adequate supervision and involvement in the ongoing conduct of the study; and (4) whether there was adequate supervision or oversight of any third parties involved in the conduct of the study. 

The draft guidance also provides recommendations for investigators for protecting the rights, safety, and welfare of clinical study subjects.  In particular, clinical investigators should provide a reasonable standard of medical care for study subjects for medical problems arising during participation in the trial, reasonable access to medical care, and attention to protocol violations that can expose study subject to unreasonable risks.

By Noelle C. Sitthikul