This training course describes the CDISC (formerly the TMF Reference Model) study master file designed specifically non-interventional studies (NIS).

Topics covered:

1. NIS Regulatory Requirements – What Must I Do?
   • Clinical Trial or Clinical Study?
   • Scope of Reg (EU) 536/2014
   • Interventional or Non-Interventional?
   • Is GCP Applicable to Non-Interventional Studies?
   • What GxPs are Applicable to Non-Interventional Studies?
2. NIS Regulatory Expectation – What Do I Need to Do?
   • Regulatory foundation and framework for RWR studies
   • We know WHAT to do. But HOW to do it?
   • ISPE Good Pharmacoepidemiologic Practice –Summary
   • Regulations & Guidance
   • Data Integrity
   • Scope of Study Master File Data and Documents
   • Inspectors’ Expectations
   • Regulations –PIC/S 011-3 (Computer Systems)
   • ISPE GAMP® Guides (Computer Systems)
3. NIS Regulatory Compliance – How Do I Prove I Did it?
   • Standardizing document management approaches for real-world studies
   • Imagine a ‘Trial Master File’ Designed for Your Observational Study…
   • Establishing the Study Master File (SMF)
   • ISPE Good Pharmacoepidemiologic Practice –Example Records
   • Scope of Studies Covered
   • Standardizing Document Management Approaches for Real-World Studies
   • Standard Contents
   • Standard Naming
   • Standard Structure
   • Standard Metadata
   • Structure of RWR Study Master File
   • SMF Adaptability
   • Benefits of the Study Master File
   • Real World Research Study Master File (Concise)
   • Real World Research Study Master File (Detailed)