This Data Monitoring Committees (DMC) webinar will guide you through the essential and the purpose of the Data and Safety monitoring plan.
Areas Covered in the Seminar:- The historical background of why Data and Safety monitoring is essential.
- The purpose of the Data and Safety monitoring plan.
- The Regulatory requirements for safety monitoring.
- Studies requiring a formal Safety Monitoring Committees.
- What does the "Charter" of a DMC compose of?
- What is the composition and function of a DMC?
- What types of studies "require" a DMC?
- Conflict of interest and the DMC.
Who Will Benefit:This Webinar will provide invaluable assistance to the pharmaceutical industry and to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Principal Investigators / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians,)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
