Masterclass Certificate in Trial Site Operations
-- ViewingNowThe Masterclass Certificate in Trial Site Operations is a comprehensive course designed to provide learners with critical skills in managing clinical trials. This course is increasingly important in the medical and pharmaceutical industries, where efficient trial site operations are essential for drug development and regulatory compliance.
2,600+
Students enrolled
GBP £ 140
GBP £ 202
Save 44% with our special offer
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โข Site Selection and Feasibility: Understanding the process of selecting appropriate trial sites, evaluating their feasibility, and establishing site selection criteria. โข Regulatory Compliance: Ensuring adherence to regulatory guidelines and standards, including ICH-GCP, FDA, and EMA regulations. โข Budgeting and Contract Management: Creating and managing trial budgets, negotiating and executing contracts with trial sites and vendors. โข Project Management: Applying project management principles to plan, initiate, execute, monitor, and control clinical trials. โข Site Initiation and Training: Designing and implementing site initiation and training programs for trial sites and personnel. โข Site Monitoring and Quality Control: Implementing site monitoring programs and quality control measures to ensure data accuracy and compliance. โข Data Management: Managing data collection, validation, and reporting, including eCRF design and implementation. โข Ethics and Patient Safety: Ensuring ethical conduct and patient safety throughout the trial, including informed consent processes and adverse event reporting. โข Trial Closeout and Reporting: Managing trial closeout activities, including final report preparation and database lock.
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