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Withdrawing from FDA-Regulated Clinical Trials

Guidance issued by the FDA regarding data retention when subjects withdraw from FDA-Regulated Clinical Trials is intended to provide a clear understanding of how already-accrued data, from participants who withdraw from a study, will be maintained as part of the study data.

When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The University of Utah IRB ensures that a statement concerning the collected information being used after a participant’s withdrawal is in the consent document. The consent document may not give participants the option of having that data removed.

For FDA-regulated research, the investigator must adhere to the following:

  • A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information.

  • The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB must approve the consent document.   

  • If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.
Last Updated: 2/5/24