Expedited Reporting. SUSARs are subject to expedited reporting. The process will be further described in the Study Specific Safety Management Plan. The Sponsor has authorised the CRO to execute its responsibilities for expedited safety report submission to the appropriate regulatory authorities within specific time periods of being notified of the event (within 7 or 15 calendar days depending the character of the SUSAR); therefore, it is important that the Investigator submit additional information requested as soon as it becomes available.
Appears in 2 contracts
Sources: Principal Investigator Agreement, Principal Investigator Agreement