Masterclass Certificate in Trial Site Management
-- ViewingNowThe Masterclass Certificate in Trial Site Management is a comprehensive course designed to equip learners with the essential skills required for managing clinical trials. This program emphasizes the importance of effective trial site management, which is crucial for ensuring the success of clinical trials and bringing new medical treatments to market.
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⢠Site Selection and Feasibility: Understanding the process of identifying and evaluating potential trial sites, including assessing feasibility and eligibility.
⢠Budgeting and Contract Management: Overview of financial planning and management for clinical trials, including creating and negotiating contracts with trial sites.
⢠Regulatory Compliance: Ensuring adherence to regulations and guidelines governing clinical trials, such as ICH-GCP, FDA, and EMA.
⢠Project Management: Techniques and best practices for managing clinical trials, including setting timelines, managing resources, and monitoring progress.
⢠Data Management: Collecting, managing, and analyzing data from clinical trials, including electronic data capture (EDC) systems and data validation.
⢠Quality Assurance and Quality Control: Implementing processes and procedures to ensure the quality of trial conduct and data, including audits and inspections.
⢠Stakeholder Communication: Effective communication with various stakeholders, including investigators, sponsors, ethics committees, and regulatory agencies.
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