FAQ: Document Retention

  1. For how long must I retain study documents, and when can I de-identify the records?

    All studies must comply with CHOP Data Retention Policy A-3-9 (available for download at https://at.chop.edu/communities/policyprocedure/administrative/Active/a-...).

    For FDA-related studies, it is important to retain the key/link until the sponsor notifies you that it is no longer necessary (which will generally occur 2 years after the last marketing approval or, if no application is filed or approved, 2 years after the FDA is notified of discontinued application). This is vital since the FDA could choose to audit the study.

    For minimal risk studies, all study data (including identifiers) should be maintained for 6 years following study completion (or longer if required by the study sponsor).

  2. How long do I need to keep copies of signed consent forms?

    The documents must be retained for must be retained for at least 6 years following study completion, or longer if required per CHOP Data Retention Policy A-3-9.

  3. How long do I need to keep documentation of HIPAA Authorization?

    If a stand-alone HIPAA Authorization or a verbal HIPAA authorization is used, the documentation must be retained for at least 6 years following study completion, or longer if required per CHOP Data Retention Policy A-3-9.

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