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Federal Regulations for Clinical Investigators. Part 312 of section 21 of The Code
of Federal Regulations covers investigational new drug application
regulations, including regulations for clinical investigators.
Guidance for Institutional Review
Boards and Clinical Investigators
Guidance For
Industry: Financial Disclosure by Clinical Investigators.
In February 1998, FDA published a final rule requiring anyone who submits a marketing application of any drug,
biological product or device, to submit certain information concerning the financial
interests of clinical investigators. The Agency is issuing this guidance to respond
to questions it has received concerning this final rule. For financial disclosure
regulations, please see Code of Federal
Regulations section 21, part 54.
FDA
Inspections of Clinical Investigators. The FDA Bioresearch Monitoring Program
involves site visits to clinical investigators, research sponsors, contract research
organizations, Institutional Review Boards (IRBs), and nonclinical (animal) laboratories.
Clinical
Investigator Regulatory Sanctions. The FDA may disqualify clinical investigators
from receiving investigational drugs, biologics and devices only when the investigator has
repeatedly or deliberately violated the Agency's regulations, or has submitted false
information to the sponsor in a required report.
Monitoring of
Clinical Investigations.
(Posted 3/2/1998) This guidance document presents acceptable approaches to monitoring
clinical investigators. Proper monitoring is necessary to assure adequate protection
of human subjects, and the quality and integrity of clinical trials data.
Investigational
Review Board Inspection Procedures from the Office of Regulatory Affair's Bioresearch
Monitoring (BIMO) program. BIMO is a comprehensive program of on-site inspections
and data audits designed to monitor all aspects of the conduct and reporting of FDA
regulated research. For more information on other BIMO compliance programs, policy
guides, guidances for industry, and compliance lists, see the BIMO webpage.
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FDA/Center for Drug Evaluation and Research
Last Updated: April 24, 2002
Originator: OTCOM/DML
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