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.