Clinical Data Management & Technology

This section covers the systems, standards, and processes used to capture, clean, manage, and secure the data generated by a clinical trial - the infrastructure layer that sits underneath trial results and regulatory submissions alike. Clinical data management has developed into its own discipline with its own body of knowledge, most notably the Society for Clinical Data Management's Good Clinical Data Management Practices (GCDMP), which documents accepted practice across areas such as case report form design, database design and validation, data cleaning and query management, and data quality metrics. Data standardization is a major theme in this cluster. CDISC (the Clinical Data Interchange Standards Consortium) publishes the data standards - including protocol, collection, tabulation, and analysis standards - that allow clinical trial data to be structured consistently enough to be pooled, reviewed, and submitted to regulators in a predictable format. These standards are what make it possible for a regulatory reviewer to work with submissions from different sponsors using a common data structure rather than a bespoke one for every trial. A second major theme is the regulatory requirements governing electronic records and electronic signatures, most notably FDA's 21 CFR Part 11, which sets out the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures for regulated activities. For a research administrator, this is the area covering electronic data capture (EDC) system selection and validation, audit trails, data integrity controls, query resolution workflows, and the standards compliance that clinical data must demonstrate before it can support a regulatory submission.

Comparisons