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PART II - IMPLEMENTATION

OBJECTIVE

*The purpose of the bioresearch monitoring program is to assure the quality integrity of data submitted to FDA to demonstrate the safety and efficacy of regulated products, and to determine that human rights and the welfare of human and animal research subjects are adequately protected.

The objective of this program is to obtain compliance of clinical investigators with the regulations and to assess through audit procedures whether records substantiate data submitted to FDA.*

PROGRAM MANAGEMENT INSTRUCTIONS

1. Coverage

All assignments for inspections will issue from Headquarters.

a. Clinical Investigators

Individuals within and outside the United States working under an application for research, or marketing permit. Areas to be covered include food additives, drugs, biologics, devices, and animal drugs (including animal food additives).

Foreign inspections of clinical investigators are assigned when the studies covered provide data critical to product approval regardless of whether the studies are conducted under an FDA application for research.

b. Sponsor/Investigators

This group consists of individuals who initiate and also conduct the study. Assignments covering this group will be relatively few in number. Most assignments of these investigators will come from the Center for Biologics Evaluation and Research.

OTHER REQUIREMENTS

1. All Headquarters and Field units are encouraged to recommend to the appropriate Center any investigator *that* they believe needs to be inspected. All recommendations should include the following:

a. the name and address of the clinical investigator,

b. the name of the test article(s) being investigated, the application for research, or marketing permit number(s), and

c. the basis for recommendation.

The Field should notify the Center contact when a previously uninspected *Institutional Review Board (IRB)* or an IRB not inspected within 5 years is identified during the course of a clinical investigator inspection.

2. The assignment memo *should* specify a due date *and the headquarters address where the EIR should be sent *. The reasons for expediting any assignment, including outstanding assignments, *should* be provided. To expedite inspections, Center personnel * may * contact the Director of the appropriate District Investigations Branch *to* request an FDA investigator *be assigned* to perform the inspection. The *designated investigator should contact* the Center contact person as soon as possible for a briefing on the background of the planned inspection and to make arrangements *for* participation by headquarters personnel. When the Center and the District agree upon arrangements, the Center will issue a confirmatory assignment, i.e. *electronic mail*, fax, mail, to the District.

3. Pre-Inspection Contact with the Center

The District will resolve any questions it has on the assignment with the appropriate Center program contact.

During the course of the inspection, additional communications will often occur between the District and the

Center. This is encouraged to ensure the rapid and efficient completion of the inspection and the report preparation.

4. Inspection Feedback

Any suggestions from the field for improvement in this program should be forwarded to the Division of Compliance Policy (DCP, HFC-230) with a copy to the Division of * Emergency and Investigational Operations* (DEIO, HFC-130)*.

5. Inspection Teams - Field/Headquarters

a. Team Leader

The field investigator will serve as team leader and is fully responsible for the conduct of the inspection in accordance with Investigations Operations Manual (IOM) section 502.4.

b. Headquarters Participants

Headquarters personnel will serve in a scientific advisory capacity to the team leader and will participate in the inspection by:

1) identifying specific studies to be covered by the inspection team and providing information pertinent to the scheduled inspection directly from the involved Center(s);

2) attending pre-inspection conferences;

3) participating in the on-site inspection; and

4) aiding as necessary in preparation of the establishment inspection report and the FDA 483 as required.

Any difficulties involving headquarters participation in the inspection should be discussed with district management and, if not resolved, immediately referred to DCP (HFC-230).

* Current Change *

Hypertext updated August 20,1998 by djv