A sponsor is preparing the Trial Master File (TMF) for a mul…

A spоnsоr is prepаring the Triаl Mаster File (TMF) fоr a multicentre clinical trial conducted in South Africa, while each research site maintains its own Investigator Site File (ISF). During a study team meeting, staff discuss which essential documents should be retained primarily by the sponsor rather than maintained exclusively at investigator sites. Which of the following document groups would most appropriately be maintained within the sponsor's TMF?