(a) The sponsor (or subsequent owners of the data) should retain the sponsor-specific essential records pertaining to the trial in accordance with the applicable regulatory requirement(s) (see Appendix C).
(b) The sponsor should inform the investigator(s)/institution(s) and service providers, when appropriate, in writing of the requirements for the retention of essential records and should notify the investigator(s)/institution(s) and service providers, when appropriate, in writing when the trial-related records are no longer needed in accordance with applicable regulatory requirements.
(c) The sponsor should report to the appropriate authority(ies) any transfer of ownership of the essential records as required by the applicable regulatory requirement(s). The sponsor should also inform the investigator if sponsorship of the trial changes.