Validating cdisc sdtm compliant submission ready clinical datasets
The consortium releases guidelines and requirements that influence the FDA and PMDA on standards for both clinical and non-clinical data.CDISC uses Controlled Terminology (CT) to unify data collected across submissions.
Small researchers or biotechnology companies that do not have the resources in-house, out-sourced this task to CROs or service providers and are not interested whether it is compliance as long as it is save them money.
Challenges of data collection It is important for the CROs / service providers to be aware of the potential challenges they may face when using different data collection methods for partnership clinical studies.
Having several clients does not mean having several standards or naming conventions. So why are many CROs or service providers not using CDISC standards? Some clinical trials run for just a few weeks / months.
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) switched to CDISC standards on October 1, 2016 and now requires that all submissions filed on or after October 1, 2016 to use CDISC compliant formats.
FDA will require all submission data for studies with an initiation date on or after December 17, 2016 to be CDISC compliant.
As with many projects, standardization projects like CDISC is a huge undertake.