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PART II - IMPLEMENTATION

  1. Objective

    2. The FFDCA requires the submission of reports of clinical investigations that have been conducted to show whether an investigational product is safe and effective for its intended use. Inspections under this program will be conducted to determine:

    1. How sponsors assure the validity of data submitted to them by clinical investigators.
    2. The adherence of sponsors, CROs, and monitors to applicable regulations.
  2. Program Management Instructions
    1. Coverage
      1. Sponsors

        2. This group consists of those individuals, organizations, or corporations that initiate clinical investigations and have been so identified by FDA through receipt of an investigational exemption, or application for research or marketing permit for an article. A sponsor is defined in the regulations at 21 CFR 312.3, 510.3(k), and 812.3(n).

      2. Contract Research Organizations

        3. This group consists of those organizations or corporations which have entered into a contractual agreement with a sponsor to perform one or more of the obligations of a sponsor (e.g., design of protocol, selection of investigators and study monitors, evaluation of reports, and preparation of materials to be submitted to FDA). In accord with 21 CFR 312.52 and 511.1(f), responsibility as well as authority may be transferred and thus the CRO becomes a regulated entity. [Note: The medical device regulations (21 CFR 812) do not contain provisions for CROs.]

      3. Monitors

      This group consists of those individuals who are selected by either a sponsor or CRO to oversee the clinical investigation. The monitor may be an employee of the sponsor or CRO, or a consultant.

    2. Procedure
      1. Inspection Teams

        2. In certain instances inspections will be conducted with Center personnel participating as team members.

        1. A field investigator will serve as team leader and is responsible for the cooperative conduct of the inspection. Responsibilities of the team leader are explained in the Investigations Operations Manual (IOM) 502.4.
        2. Center personnel will serve as scientific or technical support to the team leader and shall participate in the inspection by:
          1. Attending pre-inspection conferences when and if scheduled.
          2. Participating in the entire on-site inspection as permitted by agency priorities.
          3. Providing support, as agreed upon with the team leader, in the preparation of specific sections of the inspection report where the Center participant’s expertise is especially useful.

        Any difficulties among participants in the inspection should be discussed with District management and, if not resolved, immediately referred to the HFC-130 contact for this program.

      2. Specific
        1. If a sponsor has contracted out all or part of their responsibilities, notify the Center contact of this fact and continue the inspection. The Center will decide whether to follow up with an inspection at the CRO or monitor and issue any additional assignments.
        2. Whether a sponsor or CRO monitor is used, a monitor inspection will cover monitor's obligations for overseeing the investigation as instructed in Part III.
Hypertext updated April 5, 2001 tmc