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The Clinical Endpoint Adjudication Handbook

The Manual / Reference Book with all the topics related to the Independent Endpoint Adjudication Committees Management.

Dedicated to all Clinical Research professionals who are or are likely to become involved in Clinical Endpoint Adjudication operations. We hope that you will find it helpful, easy to use, complete and accurate.

TABLE OF CONTENT

CLINICAL OUTCOMES AND CLINICAL ENDPOINTS

  1. Clinical Outcomes
  2. Clinical Endpoints

ENDPOINT ADJUDICATION COMMITTEES (EAC)

  1. Composition Of An Endpoint Adjudication Committee
  2. Reviewers Training And Education
  3. Reviewers Validation
  4. Reviewers Substitution
  5. Reviewers Management
  6. Reviewers Qualification Quality Control (Metrics)

THE ADJUDICATION CHARTER

ADJUDICATION SOFTWARE & DATA MANAGEMENT

  1. Database & Data Management
  2. Events Management

ENDPOINT ADJUDICATION PROCESSES

  1. Event Medical Records Identification
  2. Event Medical Records Collection
  3. Event Medical Records Anonymization
  4. Event Medical Records Translation
  5. Event Medical Records Labelling
  6. Event Medical Records Format Conversion
  7. Event Medical Records Package Validation
  8. Event Medical Records Querying For More Info
  9. Event Medical Records Update
  10. Event Medical Records Versioning
  11. Event Medical Records Displaying
  12. Event Assembling Ongoing Management
  13. Event Medical Records Collection Quality Control (Metrics)
  14. Events Submission / Re-submission
  15. Reviewers Alerting To Events
  16. Adjudication Forms
  17. Review Assessment Workflow
  18. Disagreement Management
  19. Adjudication Process Ongoing Management
  20. Automated Assessment(s)
  21. Review Process Quality Control (Metrics)
  22. Adjudication Study Closure
  23. Adjudication Audit Trail
  24. Adjudication Data / Metadata Export To Submission
  25. Adjudication Medical Records Export To Submission
  26. Adjudication Data / Metadata / Medical Records Archiving

GLOSSARY

BIBLIOGRAPHY

 

Download Your Endpoint Adjudication Handbook (28 pages)

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