It is essential to understand the purpose of the PIs reviewing SUSARs. It is for safety information not only to be known by the PIs but also to be formally shared with sub-investigators and nurses, to be taken into account with subjects participating to the clinical trials related to the IMP. The Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2011_c172_01/2011_c172_01_en.pdf
) provides processes at section 7.10 - Informing the investigator. Rather than forwarding single SUSARs, some periodical SUSAR listings as well as “a concise summary of evolving safety profile of the IMP” are recommended.
An extensive description about SUSARs at investigational sites is given in the MHRA forum at http://forums.mhra.gov.uk/showthread.php?1731-SUSARs-at-Investigational-Sites
I would consult a few-year old EMA document about some combined submissions highlighting still on-going issues with SUSARs at https://www.ema.europa.eu/en/documents/presentation/all-submissions-combined_en.pdf
. Please do a search or a find about the keyword “SUSARs”. Much emphasis is put on Eudravigilance, NCAs, and IECs. It is highlighted that ECs cannot efficiently assess and process single SUSARs within the evolving safety profile of the IMP. Same for PIs and Sub-Is.