Certificate in Compliance Training for Trial Managers
-- ViewingNowThe Certificate in Compliance Training for Trial Managers is a crucial course designed to meet the increasing industry demand for professionals with a solid understanding of compliance in the clinical trial sector. This certificate course emphasizes the importance of adhering to regulations, ensuring data integrity, and protecting patient safety.
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โข Introduction to Compliance Training: Understanding Compliance, Importance of Compliance Training, Regulatory Environment
โข Legal & Regulatory Framework: Overview of Relevant Laws and Regulations, Legal Compliance in Trial Management
โข Risk Management in Clinical Trials: Identifying, Assessing, and Managing Risks, Risk Mitigation Strategies
โข Data Privacy & Security: Data Protection Principles, Securing Confidential Information, Data Breach Management
โข Good Clinical Practice (GCP): Principles of GCP, Role of Trial Managers in GCP Compliance
โข Pharmacovigilance & Adverse Event Reporting: Understanding Pharmacovigilance, Adverse Event Detection, Reporting and Follow-up
โข Quality Management & Auditing: Quality Management Systems, Internal and External Audits, Corrective and Preventive Actions
โข Ethical Considerations in Clinical Trials: Informed Consent, Ethical Trial Design, Protection of Vulnerable Populations
โข Financial Management in Clinical Trials: Budgeting, Financial Reporting, Preventing Financial Fraud
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