What should the investigator do when the investigator site closes or an investigator leaves?

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When a site closes or an investigator leaves, the priority is to protect participant rights and data integrity while keeping regulatory oversight intact. The investigator should promptly inform the sponsor about who will be responsible for maintaining essential records and arrange for the proper transfer of those records to the sponsor or to a new qualified site. This keeps the trial’s regulatory trail intact, ensures continuity of oversight, and allows ongoing access to essential documents for audits or inspections. Essential documents must be retained for the required period and made available as needed, and the appropriate ethics committee or IRB should be notified as required. Deleting records, handing them to participants, or closing the study file without notifying anyone would undermine regulatory obligations and is not appropriate.