|Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)|
|5. RESPONSIBILITIES OF THE SPONSOR|
As required by national law or regulations, the sponsor should provide adequate compensation or treatment for subjects in the event of trial-related injury or death, and provide indemnity for the investigator, except in the case of claims resulting from malpractice and/or negligence. (See Section 3.2 (e)-(f)).