|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|
The sponsor must inform the investigator(s) promptly of any immediately relevant information on safety that becomes available during a clinical trial and ensure that the ethics committee and the drug regulatory authority are notified by the investigator(s) if required (see Section 7).