The Food and Drug Administration (FDA) recently published version 3.0 of the Technical Conformance Guidelines (TCG) on March 31, 2016. The TCG provides technical specifications, recommendations and general considerations on how sponsors should submit standardized electronic study data to FDA.
Following are the updates or additional information in the TCG v3.0 that were not in the previous version.
- The maximum size of an individual dataset increases from 1 GB to 5 GB.
- SDTM datasets should be described in Define.xml and SDRG.
- ADaM datasets should be described in Define.xml and ADRG.
- SEND datasets should be described in Define.xml and SDRG (This will change into Nonclinical SDRG once it goes through public review in Federal Register).
- Define.xml v2 is the preferred version.
- FDA supports CDISC data elements from Chronic Hepatitis C and Dyslipidemia Therapeutic Area Standards.
- FDA recommends sponsors map a collected value to a controlled term rather than “OTHER”.
- The data flow diagram from collection to submission enhances the traceability (At 2016 CSS, FDA applauded sponsors for including the data flow diagram in SDRG).
You can find the new version of TCG in http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf.