Filing at study, country and site level

Question:
According to the TMF Reference Model, the master Informed Consent Form should be filed as artifact 02.02.03 but I’m not sure where a site-specific ICF should be filed. As this is a site document, should it be filed somewhere in zone 5?

Answer:
Several artifacts can be filed at multiple levels: study, country and/or site. However, the artifact number (e.g. 02.02.03) does not change. So in this example, the site specific ICF is still filed as artifact 02.02.03 but at the site-level of the sponsor TMF rather than at the study-level. Depending on the technology used in an eTMF, you may need to assign unique IDs for artifacts that exists at multiple levels within the TMF. In a paper TMF, the documents would be filed in the study-level binder, the country-level binder and/or the site-level binder(s), as appropriate.

October 24, 2016

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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