Beyond the academic/professional qualifications (CV) of the reviewers, the sponsor must verify that the reviewers have fully understood the object and nature of the study, have read and understood the protocol and the adjudication charter and have been trained in the use of any software tools involved in the adjudication process.
Three elements are key for achieving performance in the areas where qualified individuals are involved: Expertise, experience and processes. The contribution of each of these is discussed below.
Expertise: Reviewers who are members of a clinical endpoint committee are typically highly specialized in the field of the study and may even have participated in the writing of the protocol. In order to confirm the expertise of the reviewers, all documentation attesting of their qualification must be collected, verified by the sponsor or a representative thereof and filed in the trial master file (TMF). In addition, clinical studies frequently have specific requirements that go beyond the usual clinical practice and endpoint adjudication may follow a specific process that is described in the adjudication charter. Therefore, it is important to verify that reviewers have fully understood the requirements, processes and tools used in the framework of the particular study.
Experience: Before the start of the study, all reviewers of the clinical endpoint committee must be trained hands-on in study specific requirements, tools and processes by a qualified individual (sponsor employee or another committee member) and training must be documented. Reviewers must sign and date training records and those must be filed in the TMF.
Processes: It is important that reviewers understand all specific processes set for the needs of the particular study and feel comfortable following them. It is also important that they agree upfront on a consensus attitude and commit to accepting the clinical endpoint committee or the chairperson’s decision in case of disagreement. This should in no way be perceived as a challenge to the reviewer’s expertise or qualification but rather as a mean to comply with the trial requirements that sometimes may be different from routine medical practice.
The consistency and quality of reviewers’ work must be verified and corrected by randomly re-assessing previously adjudicated events (Intravariability Quality Control).
In case of discrepancy, the reviewers may be invited to compare their approach, identify the reasons and adjust their way of working. Additional training may also be offered to clarify any misunderstandings.
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