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Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.
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 Community generated an Events Charter Template for endpoint adjudication to assist those in need of guidance.
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 ensure 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 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
Identification of the Committee Chair along with his/her required expertise and related experiences should be described in detail. Roles and responsibilities of the Committee Chair should be described.
The chair should as a minimum write/update or, respectively, oversee writing/updating the Charter and the decision rules. S/he chairs the Adjudication Committee meetings, arbitrates, documents, reviews and approves meeting minutes, decisions and results, and communicates with the sponsor/Steering Committee and clinical sites, as appropriate.
The Charter will include a list of the Adjudication Committee Members including their contact information (work address, telephone number, fax number or email address), credentials and experience qualifying them for their assigned role(s). Adjudication Committee members will sign a potential conflict of interests declaration.
The roles of the Adjudication Members are to be summarized, including their responsibilities throughout the course of the clinical trial, timelines, and participation in the Adjudication Committee meetings.
Procedures are to be in place in the event that it is necessary to replace a Committee Member. The Charter keeps on file the reasons for replacing an Adjudication Committee member, such as inadequate performance and lack of communication with other members, lack of participation in consensus meetings, or inability to meet the responsibilities detailed in the Charter. Decision and communication are to be kept internal but are made available to auditors and regulatory inspectors.
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:
9. Endpoint Assessments
The Assessment process consists of the following steps:
9.1 Event Submission
9.2 Disagreement Management
9.3 Event Changed Data
10. Adjudication Deliverables
The following are examples of deliverables of the Adjudication Process:
A list of people involved in the adjudication process with their respective role (e.g., Adjudication Coordinator, Chair of the Adjudication Committee, Adjudication Committee Member), their responsibility and contact information will be maintained.
A Communication Plan is maintained to define upfront the following scenarios/requirements:
12. Timelines - Assessment of Workflow
A description and flowchart of the Endpoint Assessment Standard Procedures and Workflows should be prepared upfront and these should take into consideration key study milestones such as submission and assessment timelines as well as any other milestones defined in the trial protocol.
The sponsor's coordinator should actively manage these timelines and ensure that the adjudication process runs according to the agreed plan and, where required, issue reminders to the adjudication committee members.
13. Quality Control: Data Sources, Procedures, Analysis
A complete list of data sources and their specified format is to be defined, for example the following aspects should be addressed:
Working group Members that are contributing to this document:
Learn More at the 4th Annual Endpoint Adjudication Conference
and hear from FDA Senior Reviewer Andrew Farb, MD.