Public Faq Saer | National Medical Research Register

Serious Adverse Event (SAE) Reporting FAQ

Who will receive the Acknowledgement of Receipt (AOR) for global SUSARs submission?

All the following individuals will receive the AOR: a. Sponsor/ sponsor contact b. Clinical Research Officer (CRO) c. Principal Investigator (PI) d. SUSAR coordinators

Where can we find the user manual for detailed instructions on local SAEs/ SUSARs submission on the new SAE Reporting Platform?

You may find the ‘Local SAEs/SUSARs user manual’ on the National Medical Research Register (NMRR) homepage at www.nmrr.gov.my

Where can we find the user manual for detailed instructions on global SUSARs submission on the new SAE Reporting Platform?

You may find the ‘Global SUSARs user manual’ on the National Medical Research Register (NMRR) homepage at www.nmrr.gov.my

What would be the timeline for the reporting of “Non-life threatening SUSARs”?

For “Non-life threatening SUSARs”, initial report is to be submitted within 15 calendar days followed by a follow up report.

What would be the timeline for the reporting of “Life threatening SUSARs”?

For “Life threatening SUSARs”, initial report is to be submitted within 7 calendar days followed by a follow up report within the next 8 calendar days.