The endpoint adjudication coordinator is the key person ensuring a smooth and compliant conduct of the adjudication process during a clinical trial.
Automation can do a lot of things. But not everything.
While modern endpoint adjudication platforms such as eAdjudication are fitted with elaborate connections and algorithms that monitor clinical data, assign roles and trigger actions, every situation is unique. Every clinical trial has its particularities, every sponsor company uses different tools for clinical data management and every investigational site has its own way of working.
The entire setup is more like an orchestra and even though all musicians read the same scores, learn the same harmony theory and follow the same musical partition, the conductor is the one who makes the orchestra perform. And the best conductors have always been the composers of the music. It is the same with an adjudication coordinator: being involved in the setup of the process, the building of the charter and the tuning of the software platform is the first step for a successful performance during the trial.
Just as a conductor knows all the nuances of the music, there are two things that the Endpoint Adjudication Coordinator must know by heart: The study protocol and the Adjudication Charter. He or she must therefore be involved very early on in the setup of the study, the writing of the protocol and the writing of the charter. In addition, the Coordinator must have a good knowledge of the data capture system and processes and if possible of the source data at the study sites. Many sites today use EHR (Electronic Health Records) and can easily provide electronic copies of the original patient records when needed. Others will be required to copy, scan or picture some of the files when adjudication time comes. Keeping track of these elements can help plan and ensure prompt communication to the adjudication committee.
Read more on the duties and challenges of the endpoint adjudication coordinator in our next article: Expert v/s expert: Managing disagreement in Endpoint Adjudication
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