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
Clinical Outcomes
Clinical Endpoints
ENDPOINT ADJUDICATION COMMITTEES (EAC)
Composition Of An Endpoint Adjudication Committee
Reviewers Training And Education
Reviewers Validation
Reviewers Substitution
Reviewers Management
Reviewers Qualification Quality Control (Metrics)
THE ADJUDICATION CHARTER
ADJUDICATION SOFTWARE & DATA MANAGEMENT
Database & Data Management
Events Management
ENDPOINT ADJUDICATION PROCESSES
Event Medical Records Identification
Event Medical Records Collection
Event Medical Records Anonymization
Event Medical Records Translation
Event Medical Records Labelling
Event Medical Records Format Conversion
Event Medical Records Package Validation
Event Medical Records Querying For More Info
Event Medical Records Update
Event Medical Records Versioning
Event Medical Records Displaying
Event Assembling Ongoing Management
Event Medical Records Collection Quality Control (Metrics)
Events Submission / Re-submission
Reviewers Alerting To Events
Adjudication Forms
Review Assessment Workflow
Disagreement Management
Adjudication Process Ongoing Management
Automated Assessment(s)
Review Process Quality Control (Metrics)
Adjudication Study Closure
Adjudication Audit Trail
Adjudication Data / Metadata Export To Submission
Adjudication Medical Records Export To Submission
Adjudication Data / Metadata / Medical Records Archiving
