Question: I do not understand why artifact [xyz] is included in the TMF Reference Model as there doesn’t seem to be a regulatory requirement for it to be included.
Answer:
If there is a specific regulatory requirement for an artifact or the general opinion of the TMF Reference Model Community based on past experience is that regulatory inspectors would usually expect the artifact to be filed in the TMF, the artifact is included as a “Core” artifact (column J).
However, there are other artifacts generated on a clinical trial where it is not so clear whether or not they should be considered part of the TMF. So these are either omitted from the Reference Model or are included as “Recommended” artifacts. Artifacts are included as “Recommended” if the overall opinion of the TMF Reference Model Community is that the artifact is study-specific and contributes to explaining how the study was conducted. In an inspection, it would therefore be helpful if these “Recommended” artifacts were treated in the same way as for the “Core” artifacts….. readily accessible, secure, retained in accordance with TMF requirements etc.
Let’s use an example: 05.04.07 Financial Documentation. Whilst there is not a specific GCP requirement to include them in the TMF, it is often helpful for certain financial records (for example spreadsheets that track payments) to be considered part of the TMF and be readily available to inspectors (and to the study team!). They demonstrate how the trial was managed.
Using 05.04.07 as an example, it is important to note that
(a) inclusion of 05.04.07 does not imply that ALL financial records should be in the TMF….. it simply provides a placeholder for those financial records that your company deems should be included (perhaps just the tracking sheets/reports?); and
(b) inclusion of an artifact does not necessarily mean the records should be in one, single TMF system….. it just means they are considered part of the Trial Master File and managed as TMF content, per your company SOP(s).
January, 2016