The CDISC Submission Metadata Model was created to help ensure that the supporting metadata for these submission datasets should meet the following objectives: Provide FDA reviewers with clear describtions of the usage, structure, contents, and attributes of all datasets and variables; Allow reviewers to replicate most analyses, tables, graphs, and listings with minimal or no transformations; Enable reviewers to easily view and subset the data used to generate any analysis, table, graph, or listing without complex programming. ... The CDISC Submission Metadata Model has been defined to guide sponsors in the preparation of data that is to be submitted to the FDA. By following the principles of this model, sponsors will help reviewers to accurately interpret the contents of submitted data and work with it more effectively, without sacrificing the scientific objectives of clinical development.
Publisher
The Clinical Data Interchange Standards Consortium
Critical Arguements
CA "The CDISC Submission Data Model has focused on the use of effective metadata as the most practical way of establishing meaningful standards applicable to electronic data submitted for FDA review."
Conclusions
RQ "Metadata prepared for a domain (such as an efficacy domain) which has not been described in a CDISC model should follow the general format of the safety domains, including the same set of core selection variables and all of the metadata attributes specified for the safety domains. Additional examples and usage guidelines are available on the CDISC web site at www.cdisc.org." ... "The CDISC Metadata Model describes the structure and form of data, not the content. However, the varying nature of clinical data in general will require the sponsor to make some decisions about how to represent certain real-world conditions in the dataset. Therefore, it is useful for a metadata document to give the reviewer an indication of how the datasets handle certain special cases."
SOW
DC CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC members work together to establish universally accepted data standards in the pharmaceutical, biotechnology and device industries, as well as in regulatory agencies worldwide. CDISC currently has more than 90 members, including the majority of the major global pharmaceutical companies.
