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
Clinical Research News
Nadchodzące badania kliniczne
-
NCT04710628Jeszcze nie rekrutujęWarunki: Metastatic Thymic Carcinoma; Thymoma Type B3
-
NCT04710641Jeszcze nie rekrutujęWarunki: Hepatocellular Carcinoma; Hepatitis B; Hepatitis C
-
NCT04710654Jeszcze nie rekrutujęWarunki: Functional Constipation
-
NCT04710680Jeszcze nie rekrutujęWarunki: Colonoscopy Nonattendance; Inpatient
-
NCT04710719Jeszcze nie rekrutujęPost-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of KeloidsWarunki: Keloid; Keloid Scar Following Surgery
-
NCT04710732Jeszcze nie rekrutujęWarunki: Venous Thromboembolism
-
NCT04710758Jeszcze nie rekrutujęWarunki: Stomach Neoplasms
-
NCT04710784Jeszcze nie rekrutujęWarunki: HIV/AIDS; Sexually Transmitted Infections
-
NCT04710797RekrutacyjnyWarunki: Ovarian Cancer; Lymphadenectomy
-
NCT04710823Jeszcze nie rekrutujęWarunki: Serratus Anterior Plane Block; Thoracic Paravertebral Block; Ultrasound; Multiple Traumatic Rib Fractures; Analgesia
Recent CRA jobs
-
Sr Clinical Trial Coord - Client-dedicated
-
Sr Regulatory Affairs Specialist - Publishing and Submissions - Home Based
-
CRA (Level II), Sr. CRA, Prin. CRA - GOV
-
Clinical Team Manager, Sr. Clinical Team Manager, Prin. Clinical Team Manager - GOV
-
Client Service Representative
-
AWS Developer
-
Contract, Sr. CRA, Oncology (Central US/ North East) IQVIA Biotech
-
Medical Science Liaison, CNS / Opioid - Lower Northeast (Boston, NYC, Philadelphia) - 2526999
-
Reprezentant klientského servisu
-
Accounts Payable Accountant