Validating cdisc sdtm compliant submission ready clinical datasets
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.
There are three major standards that CDISC supports. To learn more about these data standards and the PK portion of CDISC data formatting, visit Part Two of our Blog CDISC creates standards that support the acquisition, exchange, submission, and archive of data for medical and biopharmaceutical product development.
It may be found difficult to understand the partnership in the amount of time they have.
Hence, most CROs and service providers prefer to perform manual mapping at the end of the trial, hence, re-work and manual work.
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.