A ‘not-required’ artifact is shown as core. Why?

You may notice that for artifacts 05.04.10 Subject ID Log and 05.04.11 Source Data there is no requirement for them to be in the sponsor TMF, as shown by “NO” in column N and column P of the Reference Model. But in column W, the artifact is shown as a site-level document. This may seem to be a discrepancy. However, if you look in column O and column Q, these artifacts are shown as investigator documents. So the reason they are identified as core is because they are core documents for the investigator TMF (aka ISF), and as a site document they’re filed at the site level.

Author: Eldin Rammell

TMF Reference Model Technical Administrator

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