Global Certificate in Clinical Trial Governance Essentials
-- ViewingNowThe Global Certificate in Clinical Trial Governance Essentials is a comprehensive course designed to equip learners with critical skills in clinical trial governance. This program emphasizes the importance of robust governance in ensuring the integrity, safety, and ethical conduct of clinical trials.
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โข Introduction to Clinical Trials: Understanding the basics of clinical trials, their importance, and the different phases.
โข Ethical Considerations in Clinical Trials: Exploring the ethical principles that guide clinical trials, including informed consent, patient safety, and data privacy.
โข Regulatory Framework for Clinical Trials: Examining the global regulatory landscape, including ICH-GCP guidelines, FDA regulations, and European Medicines Agency (EMA) guidelines.
โข Study Design and Protocol Development: Learning about the key components of a clinical trial protocol and how to design a study that yields valid results.
โข Site Selection and Management: Understanding the process of selecting and managing clinical trial sites, including the role of site management organizations (SMOs) and site initiation visits.
โข Investigator Site Training: Discussing the importance of investigator site training, the content of training programs, and the methods used to deliver training.
โข Data Management in Clinical Trials: Examining the principles of data management, including data entry, data cleaning, and data validation.
โข Monitoring and Quality Assurance in Clinical Trials: Understanding the role of monitoring in ensuring data quality and participant safety, and the principles of quality assurance.
โข Clinical Trial Budgeting and Contracting: Learning about the financial aspects of clinical trials, including budget development, contract negotiation, and payment terms.
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