Masterclass Certificate in Trial Site Evaluation
-- ViewingNowThe Masterclass Certificate in Trial Site Evaluation is a comprehensive course designed to equip learners with critical skills in trial site evaluation, a crucial aspect of clinical research. This certification program emphasizes the importance of rigorous site evaluation in ensuring successful clinical trials, thus addressing a key industry demand.
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โข Site Selection Fundamentals: Understanding the importance of trial site evaluation, factors to consider in site selection, and the impact on study outcomes.
โข Regulatory Compliance: Overview of regulations and guidelines governing trial site evaluation, including ICH-GCP and FDA requirements.
โข Assessing Site Infrastructure: Evaluating site infrastructure, technology, and facilities to ensure they meet the requirements of the clinical trial.
โข Investigator Qualifications: Examining investigator qualifications, experience, and track record in conducting clinical trials.
โข Patient Recruitment and Retention: Assessing site's ability to recruit and retain patients, including analysis of patient population and previous recruitment efforts.
โข Data Management and Quality Control: Evaluating site's data management capabilities, quality control processes, and previous data integrity issues.
โข Risk Assessment and Mitigation: Identifying potential risks in site selection and developing strategies to mitigate them.
โข Monitoring and Oversight: Establishing monitoring and oversight plans to ensure site compliance with the study protocol and regulations.
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