MEDICINES CONTROL AGENCY MCA THE GAMBIA SPONSOR INDEMNIFICATION FOR MCA-T-501/04 SITES AND INVESTIGATORS SUGGESTED WORDING Note: The following wording is meant to serve as guidance and is not an exclusive approach. In consideration of the [PI’s / Institution’s / Research Unit’s] participation in the study, we shall indemnify and hold harmless [Name of PI / Institution / Research Unit] and its employees from any legal liability for costs or damages for death or personal injury which may result from the administration of [Name of compound] pursuant to study [XYZ]. This indemnity does not apply to the extent that such death or personal injury arises out of any negligent act, default or omission of [Name of PI / Institution / Research Unit] or its employees. Furthermore, this indemnity is subject to the condition that the study is carried out in accordance with the protocol approved by us in writing, that [Sponsor’s name] is notified immediately on receipt of any claim, that [Sponsor’s name] shall have full control of the management and defence of any such claim, and that no offer to compromise or settle any claim is made without the written agreement of [Sponsor’s name]. MCA-T-501/04, version 2 – 24 January 2025 Page 1 of 1
