Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs

Description

This guidance is intended for sponsors, clinical investigators and institutional review boards (IRBs). It describes the Food and Drug Administration’s (FDA) longstanding policy that already-accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data. This pertains to data from individuals who decide to discontinue participation in a study, who are withdrawn by their legally authorized representative, as applicable, or who are discontinued from participation by the clinical investigator. This policy is supported by the statutes and regulations administered by FDA as well as ethical and quality standards applicable to clinical research. Maintenance of these records includes, as with all study records, safeguarding the privacy and confidentiality of the subject’s information.

Scope & Applicability

Regulatory Context

• 21CFR812.100§ 812.100 General responsibilities of investigators.

  An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under inRead full regulation →

• 21CFR312.60§ 312.60 General responsibilities of investigators.

  An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs Read full regulation →

• 21CFR56.109§ 56.109 IRB review of research.

  (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.Read full regulation →

• 21CFR50.25§ 50.25 Elements of informed consent.

  (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →

• 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.

  (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →

• 21CFR814.20§ 814.20 Application.

  (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• 21CFR812.140§ 812.140 Records.

  (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:Read full regulation →

• 21CFR312.62§ 312.62 Investigator recordkeeping and record retention.

  (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug tRead full regulation →

• In Vivo Bioavailability-Bioequivalence Studies – Clinical

  Maria A. Carballosa, M.D.

  2025-12-23

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  Celularity, Inc

  2025-12-09

• Sponsor/Investigator

  Verdure Sciences, Inc.

  2025-11-18

• Clinical Investigator (Sponsor)

  Pamela K. Den Besten, DDS, MS

  2025-09-30

• Clinical Investigator/Sponsor

  Ralph A. DeFronzo, M.D.

  2025-09-23

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Clinical Investigator

  Peter Michael, M.D.

  2025-07-01

• Clinical Investigator (Sponsor)

  American Behavioral Research Institute, LLC

  2025-06-10

• Bioresearch Monitoring Program

  Amy Lightner, MD

  2025-06-03

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