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