General Comments:
Investigator site artifacts are left out. This is inappropriate as per the MHRA - The TMF is normally composed of a sponsor file, held by the sponsor organisation, and an investigator site file, held by the investigator. These files together are regarded as comprising the entire TMF for the trial and should be established at the beginning of the trial.
Varying too far from the TMF RM in the OASIS eTMF interoperative standard will cause industry confusion; which I am sure is not your intention.
The latest industry trend is to accept the vocabulary and taxonomy as it is without much additions, deletions, or changes. There needs to be OASIS written accountability in the taxonomy for the changes to the TMF RM artifacts included, combines, or removed for industry to understand the OASIS intention…Industry deserves a map and explanation from OASIS if there is misalignment.
Just a few capitals for abbreviations is not helpful to anyone. I would replace with some type of descriptive abbreviation of the preferred term.
Stay consistent in the document naming where possible. There are noted inconsistencies for
record v documentation
trial v study (see Sharon Ames comments)
patient v subject (use subject since not all participants in a clinical trial or study is a patient).
Sincerely,
Lisa Mulcahy
412-213-3050