Certificate in Compliance Training for Clinical Investigators
-- ViewingNowThe Certificate in Compliance Training for Clinical Investigators is a comprehensive course designed to meet the growing industry demand for professionals with a deep understanding of clinical research compliance. This program equips learners with essential skills necessary for career advancement in clinical investigator roles and related areas.
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⢠Introduction to Clinical Investigator Compliance: Understanding the regulatory landscape, principles of compliance, and the role of clinical investigators
⢠Good Clinical Practice (GCP) Training: Overview of ICH GCP guidelines, responsibilities of investigators, and ensuring patient safety and data integrity
⢠Informed Consent: Processes for obtaining, documenting, and maintaining informed consent from study participants
⢠Record Keeping and Data Management: Proper documentation, storage, and retrieval of essential study-related data and records
⢠Clinical Trial Protocol Compliance: Understanding and adhering to study protocols, including eligibility criteria, study visits, and intervention administration
⢠Adverse Event Reporting: Identifying, reporting, and managing adverse events and serious adverse reactions
⢠Financial Disclosure and Conflict of Interest: Disclosing and managing financial interests and potential conflicts of interest in clinical trials
⢠Monitoring and Inspections: Preparing for and managing monitoring visits, audits, and inspections by regulatory authorities
⢠Promotion and Communication: Adhering to regulations related to the promotion and communication of clinical trials to the public and study participants
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