Module 12 Presentations

26/01/2024

Required Documentation: Reviewer’s Guides

 Define.XML does not adequately document SDTM & SEND mapping decisions, sponsor-defined domains, sponsor-defined controlled terminology, and sponsor extensions to CDISC controlled terminology.  Study Data Reviewers Guides (SDRG) help to address this documentation gap  RG should describe any special considerations or directions or conformance issues that may facilitate an FDA reviewer's use of the submitted data and may help the reviewer understand the relationships between the study report and the data.  Two SDRGs: clinical and nonclinical.

 SDRG for nonclinical studies (nSDRG) in Module 4  SDRG for clinical studies (cSDRG) in Module 5

The Organisation for Professionals in Regulatory Affairs

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Relevance to Regulatory

 Making sure all the required deliverables are provided  NOT just the xpt files – define files, annotated CRF, program files, and reviewer’s guides (per the IGs)  Assessing SDTM and ADaM compliance may be difficult to assess and requires expertise in order to submit data that will meet the requirements for regulatory approval  There are technical rejection criteria that must be adhered to

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