The transition to open data standards for all aspects of clinical trials is gathering significant momentum. Work by CDISC, TransCelerate and HL7 FHIR is resulting in a consistent set of machine-readable data standards for Study Protocols, Study Data and Study Records.

This is accelerating the transition away from a paper-based mentality of using PDF documents for data and records. Instead, all aspects of a study will become structured data that uses machine readable data models and controlled terminologies.

The regulators already support this approach for study data (for example, data used for statistical analysis). The adoption of ICH M11 and support in USDM will see a similar transition for study protocols. The inclusion of the eTMF RM into the CDISC fold and the planned revisions to align it with the CDISC standards universe will drive a similar transition for study records too.

The transition to pervasive use of open data standards for all aspects of a study will have a profound impact on approaches to retention, archiving and preservation. As Arkivum expands out of the TMF archiving niche and into the wider landscape of clinical trial data, we will need to embrace the world of clinical data standards and support them within the product. As part of this, we need to be prepared for a transition from TMFs being document (PDF) based with clunky spreadsheets to being structured data described by machine readable metadata and controlled terminologies.