I don’t see formal acknowledgment letters for PD’s and SAE’s in the site documents. Are the site files missing something?
Quorum Review IRB does not send formal acknowledgement letters for site level safety Information. Quorum sends standard acknowledgements for site level safety information or Unanticipated Problems. Quorum Review IRB will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.