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
Bevorstehende klinische Studien
-
University of Novi SadRekrutierungAkute NierenschädigungSerbien
-
The First Affiliated Hospital of Zhejiang Chinese...RekrutierungEntzündungsreaktion | Tourette-Syndrom bei Kindern | LebensmittelintoleranzChina
-
University of Rome G. MarconiUniversity of Bologna; University of the Italian SwitzerlandNoch keine RekrutierungBetonen | Schlaflosigkeit | Postpartale DepressionItalien
-
Selcuk UniversityNoch keine RekrutierungGamifizierung | Studenten der Krankenpflege | Multiple Intelligence Theory | Disaster NursingTruthahn
-
NuvoAir Medical PCOptum, Inc.Noch keine RekrutierungCOPD | COPD-Exazerbation | Cardio/Pulm: Herzinsuffizienz
-
Regeneron PharmaceuticalsIntellia TherapeuticsNoch keine Rekrutierung
-
Centro di Riferimento Oncologico - AvianoRekrutierungNicht kleinzelliger Lungenkrebs mit Metastasen | ALK-GenmutationItalien
-
Omphis FoundationRekrutierung
-
Institut de cancérologie Strasbourg EuropeContinuum Plus Santé; Plateforme nationale qualité de vie et cancer; WeShareNoch keine RekrutierungNeoplasien der Brust | Lungentumoren | Prostataneoplasmen | Kolorektale NeubildungenFrankreich
-
Al-Balqa Applied UniversityLuzmila HospitalNoch keine Rekrutierung
-
Musculoskeletal Injury Rehabilitation Research...The Geneva Foundation; Uniformed Services University (USU) of the Health Sciences und andere MitarbeiterNoch keine RekrutierungLow-Level-Lasertherapie | Photobiomodulationstherapie | Leistungssteigerung | Photomedizin | Quadrizeps | Bereitschaft für Spezialoperationen
-
The Seventh Affiliated Hospital of Sun Yat-sen...Huizhou Municipal Central Hospital; Dongguan Hospital of Traditional Chinese... und andere MitarbeiterRekrutierungOsteoporose-Fraktur | Kompressionsfraktur | Osteoporose Wirbel | Führen Sie eine PVP/PKP-Behandlung durchChina