ECRIN Metadata Schema for Clinical Research Data Objects Version 6.0 (August 2021)

This paper provides an overview of a metadata schema covering the discoverability, access and provenance of data objects generated by clinical research, including individual participant data sets, to help support the 'FAIRification' of those data objects. In fact two schemas are used - one for clinical studies, based on the data structures within ClinicalTrials.gov, and the other for related data objects, based on DataCite. Because most data objects generated by clinical research do not currently have unique titles or DOIs, the expectation is that the starting point for most searches for data objects would be the source studies, hence the requirement for the two inter-related schemas.

The main paper is a description of the schemas. Appendices provide further details of categorised data items, and tabular and JSON definitions of the detailed implementation of the schemas within the ECRIN MDR (metadata repository).