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Regulatory Affairs

  • About Regulatory Affairs
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    • Definitions
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The documents listed on this page are intended to help prepare submissions for review by regulatory bodies and the IRB. Please be sure to download the appropriate template for each use to ensure you have the latest version.

 

General Template Documents:

  • CAPA Template

     

Clinicaltrials.gov Template Documents:

  • Cover Page Template for uploaded documents
  • Protocol Template
  • Statistical Analysis Plan (SAP) Template
  • Protocol and SAP Template

 

Medical Device Template Documents:

  • Design Trace Matrix Template
  • Risk Analysis Template
  • Q-submission: Risk Determination Request Template
  • Q-submission: Pre-submission Request Template

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