Public Faq Saer | National Medical Research Register

Serious Adverse Event (SAE) Reporting FAQ

Is there a need to submit local SAEs/ SUSARs from non-MREC approved sites?

Non-MREC approved sites do not have to report the local SAEs/ SUSARs to MREC

Where should we report the local SAEs/ SUSARs which occurred at non-MREC approved sites?

Local SAEs/ SUSARs from local non-MREC approved sites should be reported to the local IRB that approved the study

Who can submit local SAE/ SUSAR reports?

The CRO, Sponsor, PI, Site Investigator, SAEs/SUSARs Coordinator, SAEs/SUSARs Correspondence Person can submit these reports.

Who can submit local SAE/ SUSAR reports?

The CRO, Sponsor, PI, Site Investigator, SAEs/SUSARs Coordinator, SAEs/SUSARs Correspondence Person can submit these reports.

How do we submit follow up reports for previously sent local SAEs/ SUSARs via Acknowledgement of Receipt (AOR)?

You need to create a new initial report via the SAE Platform on NMRR with mandatory fields filled in and proceed with submission of the latest follow up report (which should be as or more complete than the earlier ones). There is no need to attach/ upload/ resubmit the previous follow up reports.