Selection of CDISC Controlled terminology when preparing a submission to FDA, PMDA

j Jacques

on January 27, 2017

Do you have any recommendation on the version of the CDISC CT to use?

-Should we use the closes version that match the setup of the collection database?

-Should we use the most recent?

-Will the FDA, PMDA use the same version identified in the reviewers guide (SDRG)?

Forums: SDTM

s Sergiy

on January 30, 2017

FDA expects sponsors to use the most current version

Hi Jacques,

1, 2. According to FDA Study Data Technical Conformance Guide (section 6.1.2):

Generally, FDA expects sponsors to use the most current version of an FDA-supported terminology available at the time of coding.

3. Today the only place to store info about version of CDISC CT is Study Data Reviewer's Guide. Unfortunately, due to PDF format it is not machine-readable metadata. New Define-XML v2.1 may resolve this issue. There are also some other potential solutions like having SDRG in XML format (at least, some parts of it).

Meanwhile, now automatic validation is performed utilizing the most recent version of CDISC CT. In general, it's not a big problem because CDISC CT is relatively stable standard.

Regards,

Sergiy