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.
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
Clinical Research News
Upcoming Clinical Research Training and Conferences
-
on demandACROSS Global Training AcademyOnline
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
Upcoming Clinical Trials
-
RobotDreams GmbHRecruitingAngina Pectoris | Acute Coronary Syndrome | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial InfarctionAustria
-
Xinhua Hospital, Shanghai Jiao Tong University...RecruitingArtificial Intelligence | Diagnosis | Congenital Heart Disease in Children | Deep Learning | ElectrocardiogramChina
-
Synergy Spine SolutionsMCRANot yet recruitingCervical Degenerative Disc DiseaseUnited Kingdom
-
Minnesota HealthSolutionsNot yet recruiting
-
University of MichiganAtriCure, Inc.Not yet recruitingPain, Postoperative | Intrathoracic ProcedureUnited States
-
University of ExeterAdvanced Growers Limited; Ecog Pro LimitedRecruitingInflammationUnited Kingdom
-
Universiteit LeidenUniversity of AmsterdamNot yet recruiting
-
China-Japan Friendship HospitalRecruitingChronic Kidney Diseases | Lipid Metabolism Disorders | Coronary Heart DiseaseChina
-
Institute of Mental Health, SingaporeNational University of SingaporeNot yet recruiting
-
Northwestern UniversityRecruiting
-
Fangbiao TaoNot yet recruitingPerinatal Depression | Stepped Care
-
Pusan National University Yangsan HospitalNot yet recruitingGynecological Surgery