Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included?

By Mimmo Garibbo 25 Jun, 2018

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included?

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).
1. Define the type of Adjudication Committees and Membership thereof.
2. Prepare the Endpoint Adjudication Charter including the process for resolution of disagreements in adjudication.
3. Prepare a list of all external stakeholders such as AROs & CROs.
4. Prepare a list of all computerized systems involved in Endpoint Adjudication activities.
5. Create the process map and describe the Sponsor, the Adjudication Committee and the CRO interfaces and respective roles and responsibilities, namely:
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
6. Prepare a validation report for the eAdjudication Software Platform if one is used
7. Describe the format and schedule of Adjudication Committee Meetings. The following agenda topics should be considered:
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.
8. The initial agreement meeting agenda should include at minimum: 
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
1. Endpoint Adjudication Charter and Agreement
2. Adjudication Manual, Agreement and Educational Process
3. Contracts and associated supporting Documents and Materials
4. Training records for individuals involved in the adjudication process
5. For all Adjudication Committee Members:
Name
Contact details
CV
Confidentiality Agreement
Declaration of Conflict of Interest
Financial Disclosure Form
Evidence of Qualification
6. Adjudication Forms giving an exact definition of the events to be adjudicated
7. Adjudication Results Outputs:
Internal adjudication output (report)
External adjudication output (report)
Scheduled (for safety interim reviews) 
Final report of results output
8. Internal (detailed) and external (management) progress reports
9. Meeting minutes of Adjudication Committee
10. QC reports
11. QA: Reports of events, preparation of dossiers (physical or e-dossiers) internal (detailed generated from database) and external reports (total numbers, custom as needed)
12. Events' Packages (Medical Records), links to imaging or other data, summary of key data points as defined in the adjudication manual.


AUDIT TRAIL REQUIREMENTS

1. 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)
2. 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. 
3. 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.
4. 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 of Events Charter Template (LINK) and the Endpoint Adjudication Glossary

Endpoint Adjudication, Adjudication Software - EAS, Adjudication Charter, Clinical Adjudication, Central Endpoint Committee CEA, Clinical Event Committee - CEC, Central Event Committee - CEC

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