Which transformation happen to the data, how and when Audit trail: who access which information, when Version control Recommended definition Structural metadata: standards metadata Synonym OUT – included in structural metadata Definition & source Description Example Recommended definition Study-Instance Metadata or Study specific metadata Synonym Study Data Standards Study Specific Structural metadata Definition & source source] [No Study-Instance metadata is a defined grouping of metadata that serves as the most complete representation of the metadata that defines an individual study. It is commonly thought of as the set of metadata that is actually consumed by the clinical technology platform to facilitate processes that are more automated and consistent. It consists of Structural and Descriptive metadata Description Within the context of a Metadata store, Study-Instance Metadata is stored separately from the Standards Metadata, either as a set of relationships back to the Standards Metadata or as a copy of the Standards Metadata. This is dependent on the Metadata store tool in use. The Study-Instance Metadata (the most complete representation of the metadata that defines an individual study) is exported to and consumed by the clinical data platform to ensure maximal automation and consistency of the processes for trial design, execution, storage, analysis, and submission. Because the Study-Instance Metadata can consist of Structural, Standards, and Operational Metadata, there exists a wide range of purposes that can be served as Study-Instance Metadata. Trial-definition metadata per the PRM Trial-definition metadata per SDTM Trial Design Study CRFs metadata
Which transformation happen to the data, how and when Audit trail: who access which information, when Version control Recommended definition Structural metadata: standards metadata Synonym OUT – included in structural metadata Definition & source Description Example Recommended definition Study-Instance Metadata or Study specific metadata Synonym Study Data Standards Study Specific Structural metadata Definition & source [No source] Study-Instance metadata is a defined grouping of metadata that serves as the most complete representation of the metadata that defines an individual study. It is commonly thought of as the set of metadata that is actually consumed by the clinical technology platform to facilitate processes that are more automated and consistent. It consists of Structural and Descriptive metadata Description Within the context of a Metadata store, Study-Instance Metadata is stored separately from the Standards Metadata, either as a set of relationships back to the Standards Metadata or as a copy of the Standards Metadata. This is dependent on the Metadata store tool in use. The Study-Instance Metadata (the most complete representation of the metadata that defines an individual study) is exported to and consumed by the clinical data platform to ensure maximal automation and consistency of the processes for trial design, execution, storage, analysis, and submission. Because the Study-Instance Metadata can consist of Structural, Standards, and Operational Metadata, there exists a wide range of purposes that can be served as Study-Instance Metadata. Trial-definition metadata per the PRM Trial-definition metadata per SDTM Trial Design Study CRFs metadata
ET_project_MDD_v0.3_05June2013.docx