Introduction
Overview of the Different Types of Clinical Research and Understanding the GCP Focus in Each One
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA-Based)
GCP for Clinical Investigations of Devices
GCP for Clinical Trials with Investigational Drugs and Biologics
(ICH-Based)
GCP for Social and Behavioral Clinical Research
Understanding Ethics and the Role of Institutional Review Boards (IRBs) in Clinical Trials and Researches
Overview of the Role, Purpose, and Basic Requirements of the ICH E6 GCP Guidelines
Understanding the Difference Between ICH GCP E6 and U.S. FDA Regulations
Understanding the Role and Responsibilities of the Investigator in Clinical Trials
Understanding the Role and Responsibilities of Industry Sponsors in Clinical Trials Under an Investigational New Drug (IND) Application
Understanding Informed Consent Requirements and How to Obtain and Document Consent
Implementing Privacy Policies and Ensuring Confidentiality of Participants in Your Clinical Trials
Ensuring Participant Safety and Well-Being in Your Clinical Trials
Detecting, Evaluating, and Reporting Adverse Events in Your Clinical Trials
Conducting Data Quality Assurance and Integrity in Your Clinical Research
Designing and Conducting the Clinical Trial / Clinical Research Protocol
Understanding the Importance of Protocol Compliance in Your Clinical Trials
Conducting Clear and Proper Documentation and Record-Keeping in Your Clinical Trials
Understanding and Preparing for the Process of Audits and Inspections of Clinical Trials
Avoiding Research Misconduct
Recruiting and Retaining Participants for Your Clinical Trials
Crafting and Negotiating the Clinical Trial Agreement (CTA)
Summary and Conclusion |
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