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Subject: Public review comments for etmf-v1.0-Metadata Vocabulary: Category 109 Data Management
It is not clear how documents related to the definition, development, testing and procedures for a trial-specific EDC system are differentiated from those for a separate clinical database. It is often the case that one system is used for implementation at investigator sites for electronic data capture but for the data received to be imported into an enterprise clinical database (e.g. Oracle Clinical). Subcategory 109.12 appears to deal with documents related to the EDC but I’m not seeing equivalent documents for subject database (which would exist for paper CRF studies as well as for EDC studies). Eldin Rammell Managing Director, Rammell Consulting Ltd. |
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