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
Tulevat kliiniset tutkimukset
-
Bispebjerg HospitalEi vielä rekrytointiaLiikunta | Digitaalinen terveys | SairaalapotilaatTanska, Färsaaret, Grönlanti
-
Bursa Yüksek İhtisas Education and Research HospitalRekrytointiAivokuolema | Happivaraindeksi | Lopun vuorovesihiilidioksidi | Apnea -testiTurkki
-
Cairo UniversityEi vielä rekrytointia
-
Cairo UniversityEi vielä rekrytointiaTuki- ja liikuntaelinten häiriö
-
Noura Nageh Ramadan AhmedEi vielä rekrytointia
-
Chinese University of Hong KongEi vielä rekrytointiaRotator Cuff TearHong Kong
-
Chinese University of Hong KongEi vielä rekrytointiaLapsettomuus, nainen
-
Clover Biopharmaceuticals AUS PtyEi vielä rekrytointia
-
Catholic University of the Sacred HeartEi vielä rekrytointiaLääkitykseen liittyvä leuan osteonekroosi
-
Dalarna County Council, SwedenEi vielä rekrytointiaEkstravaskulaarinen keuhkovesi | Keuhkoödeema - akuuttiRuotsi
-
Dasman Diabetes InstituteRekrytointiTyypin 1 diabetes (T1D) | Tyypin 1 diabetes (T1DM)Kuwait
-
National Medical Research Radiological Centre of...RekrytointiHodgkinin lymfooma, aikuinenVenäjän federaatio