Public review comments for etmf-v1.0-csprd01: Exchange tracking/logging

["Eldin Rammell, Rammell Consulting" <eldin.rammell@rammell.com>]

Unless I have overlooked it, the specification does not provide for a tracking/logging mechanism for multiple or sequential exchanges of TMF content. For example, System A might transfer TMF content to System B at regular intervals throughout a clinical trial e.g. monthly. The specification should include metadata that tracks whether a specific object has already been transferred in a prior exchange and whether the object has changed in the source system since being transferred. This omission may have resulted from the lack of use cases within the specification?

 

Eldin Rammell

Managing Director, Rammel Consulting Ltd