What Is a Clinical Event Committee (CEC) and What Does a CRA/CSM Do in the CEC Process?

In clinical research, the data is everything, but not all data is black and white. When it comes to clinical endpoints interpretation can vary widely depending on the source. This is where the Clinical Event Committee (CEC) comes in.

What Is a Clinical Event Committee?

A Clinical Event Committee, sometimes called an Endpoint Adjudication Committee, is an independent group of physicians and/or subject matter experts responsible for reviewing and classifying certain clinical events reported during a trial. Their goal is to use their expertise to apply standardized definitions and unbiased judgment to ensure consistent and accurate endpoint assessment across all study sites.

Why Is a CEC Important?

In multicenter clinical trials, variability is inevitable. Investigators may differ in how they interpret or report adverse events or how the define the attribution definitions. Without a centralized adjudication, this can introduce bias into the data.

A CEC provides:

• Consistency: Every event is reviewed using the same criteria, regardless of where or how it was reported.

• Objectivity: Committee members are independent from the sponsor.

• Credibility: Especially in studies intended for regulatory submission, CEC-reviewed endpoints add a level of rigor that strengthens the validity of trial results.

  
  

How Does the CEC Process Work, and what does the CRA and CSM do?

1. Event Identification Study teams flag potential endpoint events from adverse event reports, hospitalizations, or follow-up assessments.

   My personal process as the CSM is to create a master excel tracker where every reported Adverse Event is reviewed for adjudication criteria. I pull the Adverse Events report at least twice a month and determine which newly- reported events need to be adjudicated. I then make a folder for each event in a folder to add the packet contents.

2. Packet Creation Relevant source documents- progress notes, discharge summaries, imaging reports- are collected by the CRA and added into event folder. As the CSM I generate a narrative to summarize the event for the CEC.

CEC Narrative Template.docx

Download DOCX • 25KB

1. Redaction & Submission All identifying and treatment-related information is redacted to prevent bias. The site redacts the subject-identifying information from the source, and as the CRA I redact further to remove the site and investigator information. The package is then submitted to the CEC moderator for submission to the CEC members.

2. Review All CECs I have worked with had 3 physicians with experience in the therapeutic area as voting members. I provide the materials to the moderator at a regular cadence, and the CEC review is completed, and the adjudications are submitted to the moderator. If all three members agree on the adjudication (see section 5 below), no further action is required. If there’s disagreement, the event is discussed during the live committee review session.

3. Classification & Documentation The event is classified according to predefined endpoint criteria, procedure- and device-relatedness. Decisions are logged in the adjudication outcome worksheet and submitted to the EDC for entry. Generally, the CEC will adjudicate to whether an event meets the definition of an endpoint, if the codi

4. ng used by the site is correct, and whether the event is an event by itself or part of another event or if the event is actually not an adverse event. TRAINING AND DOCUMENTATION IS KEY- if the CEC determines an event meets the endpoint definition, make sure to have a place to record WHY to ensure compliance to the protocol definitions. If their adjudication differs from the PI attribution, make sure to capture WHY to explain the to the site investigator.

   The final adjudication documentation should be signed off according to the charter requirements- there can be individual sheets for each event with all the CEC members signing, or the events can all be in a single excel sheet or word document with all the adjudications that only the Chairperson signs. For the latter, make sure to capture in the meeting minutes that the final adjudication record was reviewed during the meeting and each member agrees that it is correct.

5. Follow-Up If the adjudications differ from the site investigator attributions, if the CEC determines a reported event is not an adverse event, or determines that the event should be coded differently, the site PI must be notified. As the CRA I notify the PI either during an IMV (captured in the follow-up letter) or via email, and a record of this notification is stored in the TMF.

   As the CSM I know whether the adjudications will be entered into the EDC and, if so, I make sure to provide those adjudication outcomes are provided to the data manager. If the events are still on-going, I make sure to remind them to not lock the forms in the EDC!

   As the CSM I file the adjudications in the TMF.

   
   

CEC Adjudication Form Template.docx

Download DOCX • 33KB

CEC Membership and Structure

1. Expertise The CEC members are typically physicians with expertise in the therapeutic area being studied and should be held to the same standards as the trial investigators. For example, a cardiovascular trial might include interventional cardiologists, electrophysiologists, and neurologists. The committee is overseen by a Chair who ensures process integrity and timeline adherence. It is ideal to have committee members with clinical trial experience, either as a former CEC member or as an investigator.

2. Meetings may be held regularly (e.g., monthly or quarterly), or on a rolling basis as events come in.

3. Payment I prefer to have a per event payment, but I've also seen hourly. The hourly option is more burdensome for the CEC members, but may be the less expensive option.

When Is a CEC Required?

CEC adjudication is common in:

• Cardiovascular, oncology, and neurology trials

• Device studies where endpoints include strokes, embolisms, or arrhythmias

• Pivotal studies intended for regulatory approval

Final Thoughts

The Clinical Event Committee might operate behind the scenes, but their work has a major impact on the credibility and integrity of a trial. By ensuring that clinical events are evaluated fairly and consistently, the CEC helps sponsors, regulators, and clinicians trust that the outcomes truly reflect the safety and efficacy of the investigational product.