An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials

This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.

Why Should You Attend:

If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this webinar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk management such as planning, identification, quantification, action, measurement, outcome assessment, and post-implementation review of various types of risks. Also discussed will be best practices for risk analysis and prospective planning in the project plan.

Areas Covered in the Seminar:

• Common risk factors in clinical trials
• Retrospective and prospective risk analysis techniques.
• Risk management: Key techniques in risk reduction, assessment, addressing, training and communication.
• Risk analysis plan: identification, information gathering, decision, implementation and review.
• Overview of FDA requirements for risk management.
• Expectations and responsibilities of the clinical project manager.
• Role of various clinical team members: CRA, coordinators, sponsors and investigators.
• Challenges of large-scale and international clinical trials.