Endpoint Adjudication Charter Template. By the "Endpoint Adjudication in Clinical Trial" Linkedin Group

By Mimmo Garibbo 05 Feb, 2018

Download the Endpoint Adjudication Charter Template. By the "Endpoint Adjudication" Linkedin Group

Endpoint adjudication is gaining importance in the industry, however, no guidance on endpoint adjudication exists. In order to shed light on endpoint adjudication, the LinkedIn Endpoint Adjudication Professional Group generated an Events Charter Template

DOWNLOAD THE FULL-TEXT ADJUDICATION CHARTER TEMPLATE

This Blog Article should be read in conjunction with the Endpoint Adjudication Glossary and the Endpoint Adjudication Data for Submission to FDA & EMA - What Should Be Included?

1. Approval Page
The Adjudication Committee (AC) Chair and Members submit their dated signature to ensure that they have read and approved of the following Charter and its contents.

2. Study Abstract/Proposal/Introduction Page
Description of the Clinical Trial related to Adjudication, Study objectives (primary, secondary, exploratory) and the rationale behind the Endpoints Assessments adoption.

3. Purpose of an Adjudication
The objective of an adjudication is that a well-recognized group of experts in the area of the <study indication> confirms that an event took place and that for each event it fulfills the per protocol definitions. The members of the committee are not participating in the trial as principal or coinvestigators and their review ensures well reported, unbiased, blinded to treatment, count of events. When an adjudicator also participates - directly or indirectly - in the study, due diligence needs to be in place by the sponsor to avoid either adjudication of self-reports and unintentional unblinding of that adjudicator. The process should take place on a continuous timely fashion. Source documents need to be submitted on time together with the report shortly thereafter.

4. Scope of Adjudication
The Adjudication Committee is responsible for reviewing each event as defined in the protocol. Their work is independent and impartial. Such type of review is to ensure accurate counting, assessing, rating, etc. of the protocol defined "events".
Unless defined by the Charter and supported by the composition of the Committee review of safety signals or of benefit-risk assessments are out of the scope of the Adjudication Committee.

5. Adjudication Committee Membership
[... ] see below for full-text download.

6. Adjudication Committee Training
An adequate description of the training processes for new members of the Committee to adjudicate clinical endpoints will include how system access controls and blinding of reviewers will be addressed. Training will include processes, provisions, and measures to prevent intentional or unintentional unblinding of trial participants/data.

7. Endpoint Adjudication Software
A description of the Endpoint Adjudication software to be used throughout the life-cycle of the clinical trial including how systems' security (user ID, electronic signature, passwords to access), customization, and validation controls have been addressed.

8. Endpoint Adjudication Processes
This section is to include the following elements:
[... ] see below for full-text download.

9. Endpoint Assessment
The Assessment process consists of the following steps:
[... ] see below for full-text download.

10. Adjudication Deliverables
[... ] see below for full-text download.

11. Communications
[... ] see below for full-text download.

12. Timelines - Assessment of Workflow
[... ] see below for full-text download.

13. Quality Control: Data Sources, Procedures, Analysis
[... ] see below for full-text download.

14. Appendices
[... ] see below for full-text download.

DOWNLOAD THE FULL-TEXT ADJUDICATION CHARTER TEMPLATE

Contributions

Working group Members that contributed:

Mark Gichuru, B.Sc. (Hons), CCRP Research Associate
Kathryn France, BA, RN, PHN, CCRC, CCRA University of Minnesota Medical School Department of Neurology
Laura Bonilla, Senior Research Coordinator, McMaster University, PHRI
Mimmo Garibbo, Ethical GmbH – Director Endpoint Adjudication Linkedin Group Manager
Beat Widler, PhD, dipl. pharm. med. Ethical GmbH - Quality Assurance

Clinical Adjudication, Endpoint Adjudication, Adjudication Panel, Adjudication Charter, Central Endpoint Committee CEA, Clinical Event Committee - CEC, Central Event Committee - CEC

Archives

Tags

Download Ethical eAdjudication for Endpoint Adjudication Dossier

eAdjudication®
Solution Description

DOWNLOAD NOW