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You are here: Home Investigators Performance studies using in-vitro diagnostics (IVDR) Standard research file IVD performance studies K. Other documents

K. Other documents

This part of the file contains other documents relevant to the performance study.

  • K1. Assessments other institutions
  • K2. Assessment other EU member states
  • K3. Clinical trial agreements
  • K4. Relevant publications
  • K5. Data Safety Monitoring Board (DSMB) charter
  • K6. Other information
  • K7b. Performance Evaluation Plan
  • K8. Description of the processing of personal data

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