Global Certificate in Clinical Trials Planning
-- ViewingNowThe Global Certificate in Clinical Trials Planning is a comprehensive course designed to provide learners with essential skills in planning and managing clinical trials. This program emphasizes the importance of ethical considerations, regulatory compliance, and data management in clinical trials.
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โข Introduction to Clinical Trials: Defining clinical trials, phases of clinical trials, and their importance in medical research.
โข Regulatory Framework for Clinical Trials: Overview of international regulations, guidelines, and ethical considerations in clinical trials planning.
โข Protocol Development: Designing, writing, and implementing clinical trial protocols, including primary and secondary endpoints, study population, and data collection methods.
โข Site Selection and Management: Criteria for site selection, investigator qualifications, and site management strategies.
โข Patient Recruitment and Retention: Strategies for successful patient recruitment, informed consent, and retention in clinical trials.
โข Data Management: Principles of data collection, management, and monitoring to ensure data integrity and compliance with regulatory requirements.
โข Statistical Analysis: Overview of statistical methods used in clinical trials, including hypothesis testing, sample size calculation, and data interpretation.
โข Quality Assurance and Quality Control: Implementing quality management systems, internal and external audits, and corrective action plans to ensure compliance with regulatory requirements.
โข Financial Management and Budgeting: Planning and managing budgets, financial reporting, and financial compliance in clinical trials.
โข Risk Management and Pharmacovigilance: Identifying, assessing, and mitigating risks, adverse event reporting, and safety monitoring in clinical trials.
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