The sponsor should aggregate, as appropriate, and review in a timely manner relevant safety information. This includes the review of any reported unfavourable medical events occurring in participants before investigational product administration (e.g., during screening). This may result in the update of the protocol, Investigator’s Brochure, informed consent materials and related documents.
The sponsor should review the available emerging safety information to assess whether there is any new data that may affect the participant’s willingness to continue in the trial, impact the conduct of the trial, or alter the approval/favourable opinion of the IRB/IEC and/or regulatory authority(ies), as applicable. Any information of this nature should be communicated to the participants, investigator, IRB/IEC and regulatory authorities, as applicable, in a timely manner.