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FDA/PhUSE CSS 2016 Highlights

B2ap3 Large FDA PhUSE CSS 2016 Highlights

Clindata Insight is back from attending the FDA PhUSE Computational Science Symposium (CSS) 2016, in Silver Spring, MD and we would like to share the take-home messages from this great conference.

FDA highlighted the importance of Dec 17th 2016, because all studies starting after this date must be submitted as CDISC compliant standard data.   Collen Ratiffe from FDA CDER also emphasized the importance of following the e-Study Guidance andTechnical Conformance Guide.  

 Mary Doi (Office of Computation Science - OCS, CDER) and other FDA members discussed the most common data quality issues in the NDAs received since March 2015:

  • Missing or incorrect define.xml (43%)
  • Trial design domains are missing (15%) – missing TS caused error in loading into Janus
  • EPOCH variables are missing (79%)
  • CT issues (62%)
  • Duplicate records (59%)

FDA was very pleased with what CSS has accomplished in the last 5 years. Helena Sviglin (OCS CDER) emphasized the success of the Reviewer Guide - SDRG in 2012, ADRG in 2014 and most recently NSDRG.   She reminded the audience of how important reviewer guides were in the review process and also mentioned that 38% of the 2015/16 applications were missing reviewer guides. We strongly believe and recommend that reviewer guides should be prepared along with SDTM and ADaM datasets.

Collaboration is the main theme of CSS. Below is the list of working groups, made up by FDA members and industry members. The working groups will continue to meet to work on deliverables such as Study Data Standardization Plan (SDSP), white papers and standard scripts.

  • Optimizing the Use of Data Standards
  • Development of Standard Scripts for Analysis and Programming
  • Semantic Technology
  • Emerging Trends and Technologies
  • Nonclinical Roadmap and Implementation

The CSS conference offered an invaluable opportunity to hear directly from the e-data team, OC team, clinical reviewers and statistical reviewers from CDER and CBER on how they manage and review the submission data. Peng and Kevin’s participation in CSS for the last 5 consecutive years gives us the unique advantage of helping our valued clients prepare better NDA packages and develop CDISC data strategy.

 If you would like to discuss in more details about common NDA data issues, submission readiness, CDISC implementation or CSS, please contact us at. We welcome your inputs and feedback.  

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