Boston College – Clinical Research: Principles, Protocols and Procedures

May 10, 2022 - Jun 09, 2022

Online via Zoom

Posted by Boston College

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Add to Calendar + 2022-05-10 18:00 2022-06-09 21:00 America/New_York Boston College – Clinical Research: Principles, Protocols and Procedures

This course is designed to provide a thorough overview of clinical research conduct, the drug development process, the roles of the Clinical Research Associate and Clinical Research Coordinator, and other key roles in the conduct of clinical research.

Session 1: Overview of the Clinical Research Process

Session 2: Clinical Research Personnel, Service Providers, and the Site Selection Process

Session 3: Human Subject Protections and Regulatory Oversight           

Session 4: Clinical Trial Conduct, Monitoring and Record Keeping   

Session 5: Components of Ethical Evaluation of Human Research and Privacy Considerations

Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures

Session 7: Pharmacovigilance in Drug/Device Development

Session 8: Audits & Inspections: Ensuring Clinical Research Quality

Session 9: The Role of Data Management in Clinical Research

Session 10: Study Budgets and Contracts: Evaluation and Negotiation

Contact hours for this course: 30

Online via Zoom

This course is designed to provide a thorough overview of clinical research conduct, the drug development process, the roles of the Clinical Research Associate and Clinical Research Coordinator, and other key roles in the conduct of clinical research.

Session 1: Overview of the Clinical Research Process

Session 2: Clinical Research Personnel, Service Providers, and the Site Selection Process

Session 3: Human Subject Protections and Regulatory Oversight           

Session 4: Clinical Trial Conduct, Monitoring and Record Keeping   

Session 5: Components of Ethical Evaluation of Human Research and Privacy Considerations

Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures

Session 7: Pharmacovigilance in Drug/Device Development

Session 8: Audits & Inspections: Ensuring Clinical Research Quality

Session 9: The Role of Data Management in Clinical Research

Session 10: Study Budgets and Contracts: Evaluation and Negotiation

Contact hours for this course: 30

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