Is there a need to submit a local SAE/ SUSAR report from non-MREC approved sites?
No, the SAE/ SUSAR report obtained from a non-MREC approved site does not need to be reported to MREC.
Where should a local SAE/ SUSAR which occurred at non-MREC approved sites be reported?
Local SAE/ SUSAR from local non-MREC approved sites should be promptly reported to the local Institutional Review Board (IRB) from which they have been granted ethical approval since the ethical issues arising from these SAE reports shall be falling under their jurisdiction.
When should a SAE follow-up report need to be submitted?
Follow-up report is only necessary if the SAE is still ongoing at the time of initial reporting. If the outcome is already known at the time of initial reporting, then it is not necessary to provide a follow-up report. In this case, only an initial SAE report shall suffice. It should be submitted following the timeline provided, however any follow-up information which provides significant findings to the SAE should be submitted as soon as they become available.
Who can submit local SAE/ SUSAR reports?
Principal Investigator (PI), Site Investigator (SI), SAE/SUSAR Coordinator, SAE/SUSAR Corresponding Person (CP) can submit these reports.
Who would be the person responsible for assessing if the global SAE fits the SUSAR criteria?
PI would be responsible for the assessment of global SAE which fits the SUSAR criteria.