Global Certificate in Trial Operations Performance
-- ViewingNowThe Global Certificate in Trial Operations Performance (GTOP) course is a comprehensive program designed to enhance the skills of clinical trial professionals. This course focuses on the importance of effective trial operations, which are critical in ensuring the success of clinical trials.
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⢠Trial Operations Fundamentals: Understanding the basics of clinical trial operations, including study design, site selection, and project management.
⢠Regulatory Compliance: Ensuring adherence to global regulations and guidelines, including ICH-GCP, FDA, and EMA.
⢠Site Management: Managing relationships with investigator sites, including site initiation, training, and monitoring.
⢠Data Management: Collecting, cleaning, and managing clinical trial data, including eCRF design and implementation.
⢠Pharmacovigilance: Managing safety reporting and adverse event monitoring throughout the trial.
⢠Quality Management: Implementing and maintaining quality systems, including SOP development and CAPA management.
⢠Budgeting and Financial Management: Developing and managing study budgets, including sponsor and site financial agreements.
⢠Vendor Management: Selecting, managing, and monitoring vendors, including CROs and other service providers.
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