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Panel Discussion Breakout Session 1: Nonclinical Topics Working Group

Data Inconsistency Between SEND Datasets and Study Reports. Panel Discussion Breakout Session 1: Nonclinical Topics Working Group. Disclaimer:

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Panel Discussion Breakout Session 1: Nonclinical Topics Working Group

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  1. Data Inconsistency Between SEND Datasets and Study Reports Panel Discussion Breakout Session 1: Nonclinical Topics Working Group Disclaimer: The opinions expressed in this document are those of the authors and do not necessarily represent the opinions of PhUSE, members' respective companies or organizations, or regulatory authorities. The content in this document should not be interpreted as a data standard and/or information required by regulatory authorities.

  2. Data Inconsistency Between SEND Datasets and Study Reports: Methodology and Goals Update to IG or model or Technical Conformance Guide Vendors supply new versions of tools Address in SEND generator tool Address in report Document in SDRG Controlled Terms Pretest Data Sig figures Severity

  3. Team Learnings: • All discrepancies between study reports and SEND datasets should be called out in the nSDRG • Terminology differences between study reports and SEND datasets will take significant time, if ever, to eliminate due to the effort it will take to reconcile legacy terminology. This is confounded by the frequency in which new terms are introduced and Controlled Terminology is updated. • There is real opportunity for technical vendors to update SEND and reporting tools to reduce some existing differences. (A new project?) • Some existing discrepancies will require FDA input, clarifications or changes to the IG. • We propose for consideration that study listings be replaced by the SEND datasets, thus removing the requirement for sponsors to supply listings in study reports. (A new project?). Further, is there an opportunity in the very long term future to adopt standards that would replace summary listings. • Because dataset and report discrepancies are not expected to be eliminated completely, our team recommends that with the publication of our white paper, this project be closed and the outstanding issues, recommendations and conclusions noted within be folded into existing or new projects.

  4. Expected and Acceptable Discrepancies - Draft

  5. Expected and Acceptable Discrepancies (cont’d) - Draft Update after Data Comparison Review

  6. Expected and Acceptable Discrepancies (cont’d) - Draft Update after Data Comparison Review

  7. Discrepancies Requiring Action - Draft

  8. Non-actionable Discrepancies - Draft

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