This webinar will provide invaluable assistance 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. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan/protocol. This 'plan' is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices Depending on the nature of the test agent, the length of the study or the number of sites conducting the clinical study, the 'Plan' may set the 'Charter' of what is called a Data and Safety Monitoring Board (DSMB) or Committee (DSMC). DSMB's and their composition play an increasingly important roll in both multi-center studies and where there is an expected or possible adverse event. The 'Stopping Rules' are an important element in the Charter. The overriding reason for a carefully selected DSMB is to promote and guarantee human subject safety.
Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices Depending on the nature of the test agent, the length of the study or the number of sites conducting the clinical study, the 'Plan' may set the 'Charter' of what is called a Data and Safety Monitoring Board (DSMB) or Committee (DSMC). DSMB's and their composition play an increasingly important roll in both multi-center studies and where there is an expected or possible adverse event. The 'Stopping Rules' are an important element in the Charter. The overriding reason for a carefully selected DSMB is to promote and guarantee human subject safety.
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 plan.
- What does the 'Charter' of a DSMB compose of?
- What is the composition and function of a DSMB.
- What types of studies 'require' a DSMB.
- Conflict of interest and the DSMB.
Who Will Benefit:
This webinar will provide invaluable assistance 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).
- QA/QC auditors and staff.
- Clinical Research Data managers
Course Provider
Charles H Pierce,
