• Presiding Officer Summary Decisions, Presiding Officer Reports, and Commissioner’s Decisions for Clinical Investigator Disqualification 

This database lists and links to copies of presiding officer summary decisions, presiding officer reports, and Commissioner’s decisions1 that have been issued concerning a regulatory hearing under Title 21, Code of Federal Regulations, Part 16 (21 CFR part 16) on the proposed disqualification of a clinical investigator from eligibility to receive investigational products and eligibility to conduct certain studies that support an application for research or marketing permit for products regulated by the Food and Drug Administration (FDA).

FDA regulates clinical investigations that are designed to develop evidence to support the safety and effectiveness of certain products regulated by FDA (e.g., investigational human and animal drugs, biological products, and medical devices). The data from these investigations may be used to support marketing applications submitted to FDA for such products. Clinical investigators who conduct clinical trials must comply with FDA's regulations that govern clinical investigations.

FDA may disqualify a clinical investigator if the agency has information indicating that the investigator has repeatedly or deliberately failed to comply with the regulatory requirements for conducting clinical investigations, or repeatedly or deliberately submitted to FDA or the study's sponsor false information in any required report. The disqualification process is initiated when the FDA Center with jurisdiction over the investigational product used in the clinical investigation provides the investigator written notice of the matter complained of and offers the investigator an opportunity to explain in writing or, at the option of the investigator, at an informal conference.   The Center provides this written notice by way of a “Notice of Initiation of Disqualification Proceedings and Opportunity to Explain” (NIDPOE).  If the Center does not accept the investigator's explanation or if the investigator fails to respond to the NIDPOE, the agency will send the investigator a Notice of Opportunity for Hearing (NOOH).

Hearings related to clinical investigator disqualifications are informal regulatory hearings conducted under 21 CFR part 16. Under part 16, if a clinical investigator requests a hearing, a presiding officer will be designated to conduct the regulatory hearing. A request for a hearing may be denied, in whole or in part, if the Commissioner or the FDA official to whom authority is delegated to make the final decision on the matter determines that there is no genuine and substantial issue of fact raised by the material submitted.  If a hearing is conducted, the presiding officer prepares a written report of the hearing, including a recommended decision on the proposed disqualification. The presiding officer's report is one component of the administrative record of the regulatory hearing. Based on the administrative record, the Commissioner issues a written decision on the question of whether the investigator is eligible to receive investigational products and eligible to conduct certain studies that support an application for research or marketing permit for products regulated by FDA.

Presiding officer summary decisions, presiding officer reports, and Commissioner’s decisions are not published in the Federal Register.  In 2001, FDA announced that it was making available an index to, and copies of, presiding officer summary decisions, presiding officer reports, and Commissioner’s decisions on clinical investigator disqualification matters. The database with links to copies of presiding officer summary decisions, presiding officer reports and Commissioner’s decisions, can be found here. These records are also available for public examination in the Division of Dockets Management.

INDEX   Note:  This Index contains those presiding officer summary decisions, presiding officer reports and Commissioner’s decisions for clinical investigators who requested a regulatory hearing, regardless of the outcome.  That is, some individuals were disqualified but other individuals remained eligible to receive investigational articles.  Additional information on the current status of a clinical investigator disqualification matter can be found in the Clinical Investigator – Disqualification Proceedings Database.  We also note that the presiding officer summary decisions, presiding officer reports, and Commissioner’s decisions in this index may contain redactions consistent with the statutory and regulatory provisions governing information disclosure.