Are you planning to submit Endpoint Adjudication Data to the FDA or the EMA? Submitted material are not only essential for obtaining marketing authorization but also a reflection of the quality of your company’s work. To help you perform a quality process and submit a compliant package to the authorities, you will find below a description of how to get started, which processes to put in place before starting and what to include in the Submission Package
TO GET STARTED
Before starting any Endpoint Adjudication activities make sure that the following processes are in place and that all relevant documents are finalized and effective (i.e., approved by all applicable stakeholders).
- Who prepares the event package
- Type of packages to be used: e-package or paper package
- Protection of e-packages (password management)
- Who will have access to the adjudication database
- Required materials
- Discussion
- Decisions
- Actions
- CAPAs
- Follow-up actions
- The approval process of minutes and correction rules before minutes officially become part of the adjudication dossier.
- Discussion of the trial protocol
- Impact of protocol provisions on adjudication activities and tasks
- Critical adjudication tasks
- Time criticality of adjudication assessments
- Definition of the adjudication dossier/package
- Rules for defining and assessing the event
- Training requirements of new adjudicators
- Training package
- Identification of trainer(s)
- Back-up and contingency plans
WHAT SHOULD BE INCLUDED IN THE SUBMISSION PACKAGE FOR THE FDA AND THE EMA
- Endpoint Adjudication Charter and Agreement
- Adjudication Manual, Agreement and Educational Process
- Contracts and associated supporting Documents and Materials
- Training records for individuals involved in the adjudication process
- For all Adjudication Committee Members:
- Name
- Contact details
- CV
- Confidentiality Agreement
- Declaration of Conflict of Interest
- Financial Disclosure Form
- Evidence of Qualification
- Adjudication Forms giving an exact definition of the events to be adjudicated
- Adjudication Results Outputs:
- Internal adjudication output (report)
- External adjudication output (report)
- Scheduled (for safety interim reviews)
- Final report of results output
- Internal (detailed) and external (management) progress reports
- Meeting minutes of Adjudication Committee
- QC reports
- QA: Reports of events, preparation of dossiers (physical or e-dossiers) internal (detailed generated from database) and external reports (total numbers, custom as needed)
- Events' Packages (Medical Records), links to imaging or other data, summary of key data points as defined in the adjudication manual.
AUDIT TRAIL REQUIREMENTS
- Any manual change of a CRF/form data field must be clearly identified with a Change Request (in this case a note to file) and complete audit trail of the change (in this case a change report)
- The PDF package for each event must contain one form per adjudication made, including re-adjudications and QC override including all adjudication phases/ forms and their status.
- The Audit Trail must include the date and time of change, the user and role who performed the change, the type of operation made and the event status.
- The Audit Trail for the dossier must list the date and time of the uploads, including initial upload and all changes made (e.g., re-uploads).
Additional useful details can be found in Endpoint Adjudication Charter Template
DOWNLOAD NOW THE ENDPOINT ADJUDICATION HANDBOOK
The Complete Manual / Reference Book with all the topics related to the Independent Endpoint Adjudication Committees Management
