The feasibility team follows up and conducts in-depth telephone interviews or sets up face-to-face meetings to discuss study-specific topics in detail to identify and resolve potential challenges that may jeopardize patient recruitment. It is this proactive approach that helps ensure the success of the project. helps define the project plan and, where applicable, refines the protocol. Feedback from the investigators on inclusion and exclusion criteria, co-medication, study procedures, patient recruitment, etc. Potential investigators are contacted by phone to determine their interest in the study, followed by an initial feasibility questionnaire to assess the study design’s overall feasibility. Based on TFS’ previous experience and broad investigator network of key opinion leaders (KOLs) and principal investigators, the team has access to a large pool of sites to involve in study feasibilities across a broad range of therapeutic indications. Australia is unique in that its Human Research Ethics Committees (HRECs) have responsibility for the oversight and ongoing monitoring of trials, including reviews and approvals.
CLINICAL TRIAL START UP TRIAL
Clinical trial performance metrics are data points. The use of metrics is two-fold: improving processes internally and strengthening relationships with sponsors. The team assesses each project’s specific needs, performs a thorough risk assessment, and drives contingency planning, which results in well thought out recommendations and potential alternative scenarios.įor each project, a Feasibility Manager is appointed, supported by a dedicated team of local feasibility specialists to manage local interactions in individual countries. All clinical research starts with the research protocol, a document that details all aspects of the trial: its background, rationale, objectives, design, methodology, statistical analysis plan, and organization.With the protocol, you can make sure you protect the participants and collect the data. An at-a-glance round-up of the arrangements for clinical trial applications in 10 countries in the region. Clinical trial performance metrics (also commonly referred to as operational metrics, or key performance indicators) are data points that provide insight into operational performance.
A dedicated feasibility team, including medical, regulatory, and clinical research professionals, coordinates feasibility surveys for each clinical trial.
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