I do not understand why this set of documents is classified as a separate category. These are documents that are specific to individual trial subjects. Completed case report forms are integrated into the Data Management category so I would expect this set of documents to also be integrated into the most appropriate of the existing categories e.g. data management or Site Management.
In addition, medical imaging documents is just one example of source documents that ICH GCP requires the investigator to maintain within a trial master file. It is not understood therefore why medical imaging documents have been included but not for other source documents. The definition should also make it clear that source documents such as these are the responsibility of the investigator and NOT the sponsor.
Finally, it is not understood why there is this level of granularity provided. I would expect a smaller number of content types to be list, requiring the system to apply metadata to differentiate between different imaging types if this was important/necessary for filing purposes. Providing this level of granularity runs the risk of the vocabulary needing to be revised as new imaging technology and techniques are used. Generic terms should be used.
Karen
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