Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation of a now well-established clinical trial data language. These data standards enable the Health Regulatory Agencies to modernize and streamline the review process.
Moreover, effective September 15, 2021, the FDA officially implemented the Technical Rejection Criteria (TRCs); this means that the TRC could now block your submission if your Electronic Technical Document (eCTD) package fails any of the eCTD Validation Criteria [1] and same for datasets included in the package [2,3,4]. After the long investment in a clinical trial, the last place you want your trial to fail is in the structure and quality of data submitted.
Through his blog series, Angelo Tinazzi, Senior Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel, has been sharing his insights and experiences on data submission. The application of CDISC standards in different therapeutic areas is part of Angelo’s core expertise since 2003, particularly in the context of data submission to health authorities such as the FDA and PMDA.
Angelo is an authorized CDISC instructor as well as member of the CDISC European Committee where he also manages the Italian-speaking CDISC User Network.
For this week’s Winter Weekend Reads, here is an eBook that compiles many of Angelo’s critical insights on data standards submission.
Reference:
[1] Specifications for eCTD Validation Criteria https://www.fda.gov/media/87056/download
[2] Study Data for Submission to CDER and CBER Main Page
[3] FDA Study Data Technical Rejection Criteria (TRC): What you need to know!, FDA Webinar, May 2021
[4] FDA Conformance Analysis and Upcoming Implementation of Technical Rejection Criteria for Study Data, CDER Presentation; PhUSE US Connect 2021
