Bioequivalence and Bioavailability Forum

Dear Sanil,

According to the ICH GCP guideline:

§5.21: If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s).

1. Check what the regulatory requirements are in your country.
2. Notifying the regulatory authorities is a sponsor responsibility; check in the contract between the CRO and the sponsor whether contacts with authorities were delegated to the CRO or whether the sponsor kept that task. If there is no mention in the contract, by default the sponsor is supposed to take care of the notification to the regulatory authority (§5.2.3).

Regards
Ohlbe