Guidance For Industry Investigator Responsibilities – Protecting The Rights, Safety, And Welfare Of Study Subjects

Contains Nonbinding Recommendations

TABLE OF CONTENTS

I. INTRODUCTION
II. OVERVIEW OF INVESTIGATOR RESPONSIBILITIES
III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES

A. SUPERVISION OF THE CONDUCT OF A CLINICAL INVESTIGATION
1. What Is Appropriate Delegation of Study-Related Tasks?
2. What Is Adequate Training?
3. What Is Adequate Supervision of the Conduct of an Ongoing Clinical Trial?
4. What Are an Investigator’s Responsibilities for Oversight of Other Parties Involved in the Conduct of a Clinical Trial?

B. PROTECTING THE RIGHTS, SAFETY, AND WELFARE OF STUDY SUBJECTS.
1. Reasonable Medical Care Necessitated by Participation in a Clinical Trial.
2. Reasonable Access to Medical Care.
3. Protocol Violations that Present Unreasonable Risks.

ATTACHMENT A: COPY OF FORM 1572.
ATTACHMENT B: INVESTIGATOR RESPONSIBILITIES.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)

Additional copies are available from:
Office of Training and Communication
Division of Drug Information, HFD-240
Center for Drug Evaluation and Research
Food and Drug Administration
(Tel) 301-827-4573

http://www.fda.gov/cder/guidance/index.htm or
Office of Communication, Training and Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration

http://www.fda.gov/cber/guidelines.htm (Tel) 800-835-4709 or 301-827-1800 or
Office of Health and Industry Programs
Division of Small Manufacturers, International, and Consumer Assistance, HFZ-220
Center for Devices and Radiological Health
Food and Drug Administration
Tel: 1-800-638-2041

http://www.fda.gov/cdrh U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Procedural
October 2009