Guidance to Principle Investigators for submissions of documents
Guidelines for submitting adverse events/SAEs/DSMB Reports or other documents to the ERC
To submit adverse events/SAEs/DSMB Reports or other documents to the ERC the WHO TO is required to submit a memo/cover page to the ERC Secretariat, attached to the documents, that has the protocol ID in its reference line, explaining the nature of documentation, and detailing the follow-up action taken in response (if relevant).