Clinical Project Managers need to have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial data, and even other more severe penalties.
Areas Covered in the Seminar:
- Overview of FDA requirements for clinical trials under an IND or IDE application.
- Regulatory responsibilities of the clinical project manager.
- An ideal clinical trial protocol and processes to amend it.
- Addressing adverse events and safety reporting.
- Management of randomization, blinding, unblinding, and DSMB review.
- Managing investigational products: stability, storage, accountability, and expiry.
- IRB review and review of the IRB processes by sponsors.
- Recruitment strategies.
- What and what documents not to submit to FDA.
- When and how to seek regulatory clarification.
- Risk management: Key techniques in risk reduction, assessment, addressing, training and communication.
- Corrective and Preventive Actions (CAPA) for clinical trial projects.
- Do's and don'ts of investigator meetings.
- Challenges of large-scale and international clinical trials.