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                Clinical Trials and Human Subject Protection

Clinical Trials and Human Subject Protection

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          Clinical Trials and Human Subject Protection
          Disqualification of a Clinical Investigator (9/5/1997)Clinical Trials and Human Subject Protection Disqualification of a Clinical Investigator (9/5/1997)
  
  	
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    PrintWAIS Document Retrieval[Federal Register: September 5, 1997 (Volume 62, Number 172)] [Rules and Regulations]                [Page 46875-46876] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr05se97-6] DEPARTMENT OF HEALTH AND HUMAN SERVICES  Food and Drug Administration  21 CFR Part 312  [Docket No. 95N-0138] Disqualification of a Clinical Investigator  AGENCY: Food and Drug Administration, HHS.  ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the  investigational new drug regulation that provides for disqualification  of clinical investigators who submit false information. The revision is  intended to clarify the agency's authority to reach sponsor- investigators under the regulation. EFFECTIVE DATE:  November 4, 1997. FOR FURTHER INFORMATION CONTACT: Thomas C. Kuchenberg, Center for Drug  Evaluation and Research (HFD-7), Food and Drug Administration, 7500  Standish Pl., Rockville, MD 20855, 301-594-1046. SUPPLEMENTARY INFORMATION: Background FDA is amending the regulations governing the disqualification of  clinical investigators to clarify that Sec. 312.70 (21 CFR 312.70)  reaches sponsor-investigators. Part 312 (21 CFR part 312) requires sponsors to monitor the  progress of clinical investigations, to review and evaluate evidence  relating to the safety and effectiveness of the drug under  investigation, and to report to FDA information based on these  monitoring and review activities. Clinical investigators conduct  clinical trials on new drugs and submit the resulting data to  individual or corporate sponsors. Data generated by the clinical  investigators are the subject of the reports submitted by sponsors to  FDA. In the Federal Register of February 16, 1996 (61 FR 6177), FDA  proposed amending Sec. 312.70 by adding language that would clarify  that FDA can disqualify clinical investigators, including sponsor- investigators, for submitting to sponsors or to FDA false information  in any required report. Under current Sec. 312.70(b), the agency may  disqualify an investigator who has ``deliberately or repeatedly  submitted false information to the sponsor in any required report.''  However, unlike investigators, sponsor-investigators, who both directly  conduct investigations and report data to FDA, submit information  directly to FDA and not to a separate sponsor. Because Sec. 312.3(b)  specifically states that the ``requirements applicable to a sponsor- investigator under this part include both those applicable to an  investigator and a sponsor,'' Sec. 312.70(b) encompasses the  disqualification of sponsor-investigators. This has been the agency's  long-standing interpretation for clinical investigator  disqualifications for drugs, animal drugs, and devices. However, for  clarity, the agency is amending this regulation to make specific  reference to FDA and to sponsor-investigators. FDA also intends in the  near future to review and harmonize the clinical investigator  disqualification provisions under device and animal drug regulations  (21 CFR 812.119 and 511.1(c)) with the changes made in this final rule. Comments on the Proposed Rule FDA received one comment on the proposed rule. The comment  commended FDA for the proposed amendment to Sec. 312.70, stating that  it is imperative that data supporting the safety and efficacy of  pharmaceuticals be accurate and reliable. The comment noted that it was  in the best interest of patients, investigators, pharmaceutical  companies, and the Government that FDA be able to assure the integrity  of data. The comment also expressed support for the disqualification of  a clinical investigator who has deliberately or repeatedly supplied  false information to a sponsor or to FDA. FDA welcomes comments and suggestions from all persons interested  in protecting the integrity of clinical data. The deliberate submission  of false information by those directly responsible for administering or  dispensing an investigational new drug subverts the integrity of the  review process. At worst, such actions may endanger public health and  safety and, at a minimum, will challenge public confidence in a review  process that is conducted with honesty by the vast majority of  investigators and sponsor-investigators. Environmental Impact The agency has determined under 21 CFR 25.24(a)(8) that this action  is of a type that does not individually or cumulatively have a  significant effect on the human environment. Therefore, neither an  environmental assessment nor an environmental impact statement is  required. Analysis of Impacts FDA has examined the impacts of the final rule under Executive  Order 12866 [Page 46876] and the Regulatory Flexibility Act (5 U.S.C. 601-612). Executive Order  12866 directs agencies to assess all costs and benefits of available  regulatory alternatives and, when regulation is necessary, to select  regulatory approaches that maximize net benefits (including potential  economic, environmental, public health and safety, and other  advantages; distributive impacts; and equity). The agency believes that  this final rule is consistent with the regulatory philosophy and  principles identified in the Executive Order. In addition, the final  rule is not a significant regulatory action as defined by the Executive  Order and so is not subject to review under the Executive Order. The Regulatory Flexibility Act requires agencies to analyze  regulatory options that would minimize any significant impact of a rule  on small entities. Because this regulation does not impose reporting,  recordkeeping, or other economic burdens, the agency certifies that the  final rule will not have a significant economic impact on a substantial  number of small entities. Therefore, under the Regulatory Flexibility  Act, no further analysis is required.List of Subjects in 21 CFR Part 312 Drugs, Exports, Imports, Investigations, Labeling, Medical  research, Reporting and recordkeeping requirements, Safety. Therefore, under the Federal Food, Drug, and Cosmetic Act and under  authority delegated to the Commissioner of Food and Drugs, 21 CFR part  312 is amended as follows: PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION The authority citation for 21 CFR part 312 continues to read as  follows:  Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of  the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,  352, 353, 355, 356, 357, 371); sec. 351 of the Public Health Service  Act (42 U.S.C. 262).Section 312.70 is amended by revising the first sentences of  paragraphs (a) and (b) to read as follows:  Sec. 312.70  Disqualification of a clinical investigator.(a) If FDA has information indicating that an investigator  (including a sponsor-investigator) has repeatedly or deliberately  failed to comply with the requirements of this part, part 50, or part  56 of this chapter, or has submitted to FDA or to the sponsor false  information in any required report, the Center for Drug Evaluation and  Research or the Center for Biologics Evaluation and Research will  furnish the investigator written notice of the matter complained of and  offer the investigator an opportunity to explain the matter in writing,  or, at the option of the investigator, in an informal conference. * * * (b) After evaluating all available information, including any  explanation presented by the investigator, if the Commissioner  determines that the investigator has repeatedly or deliberately failed  to comply with the requirements of this part, part 50, or part 56 of  this chapter, or has deliberately or repeatedly submitted false  information to FDA or to the sponsor in any required report, the  Commissioner will notify the investigator and the sponsor of any  investigation in which the investigator has been named as a participant  that the investigator is not entitled to receive investigational drugs.  * * * * * * * * Dated: August 29, 1997. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 97-23587 Filed 9-4-97; 8:45 am] BILLING CODE 4160-01-F

                                                                                  Content current as of:
      09/18/2015Clinical Trials and Human Subject Protection

          
                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries
 
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