Masterclass Certificate in Clinical Trials Compliance Strategies
-- ViewingNowThe Masterclass Certificate in Clinical Trials Compliance Strategies is a comprehensive course that equips learners with crucial skills for career advancement in the clinical trials industry. This certificate program emphasizes the importance of compliance in clinical trials, an area of growing significance as regulatory scrutiny increases and penalties for non-compliance become more severe.
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Here are the essential units for a Masterclass Certificate in Clinical Trials Compliance Strategies:
⢠Regulatory Frameworks for Clinical Trials: This unit covers the key regulations and guidelines that govern clinical trials, including ICH-GCP, FDA regulations, and EU directives. It also discusses the role of IRBs and ethics committees in ensuring compliance.
⢠Risk-Based Quality Management: This unit explores the principles of risk-based quality management in clinical trials, including risk identification, assessment, and mitigation strategies. It also covers the role of quality management systems in ensuring compliance.
⢠Data Management and Integrity: This unit discusses the importance of data management and integrity in clinical trials, including data collection, validation, and reporting. It also covers the use of electronic data capture (EDC) systems and the challenges of data security and privacy.
⢠Monitoring and Auditing: This unit covers the principles of monitoring and auditing in clinical trials, including the roles and responsibilities of monitors and auditors, the different types of monitoring and auditing, and the documentation required to demonstrate compliance.
⢠Pharmacovigilance and Safety Reporting: This unit explores the principles of pharmacovigilance and safety reporting in clinical trials, including the reporting of adverse events, serious adverse events, and suspected unexpected serious adverse reactions (SUSARs). It also covers the role of the pharmacovigilance system master file (PSMF) and the challenges of global safety reporting.
⢠Inspection Readiness: This unit prepares participants for regulatory inspections, including the documentation required, the inspection process, and the role of the inspection team. It also covers the importance of corrective and preventive action (CAPA) plans in addressing any findings from inspections.
⢠Ethics and Patient Engagement: This unit discusses
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