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Validity : 20th Apr'24 to 30th Apr'24
Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How
- 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.
Overview of the webinar
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 role 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.
Who should attend?
- 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
Why should you attend?
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.
Faculty - Mr.Charles H Pierce, MD, PhD, FCP, CPI
Enjoys making presentations and Webinars on a variety of GCP subjects such as Investigator Responsibility in Clinical Research, The Role of Adverse Event Determination and Reporting in Drug Safety, Data and Safety Monitoring Board set-up and use, Importance of Conflict of Interest Avoidance, What is "GCP", How to Document to have a good FDA Inspection, How to prepare for an FDA BIMO Inspection, The Importance of effective Pharmacovigilance.
Specialties
- Developing Phase I, IIa Clinical Pharmacology Units (CPU) -
- The safety of the results of Clinical Research - Phase IV (Pharmacovigilance)is essential
- Clinical Research study conduct from the Regs to practice - including post-market safety
- Giving Lectures and Webinars on the GCP of Clinical Research - Value of Lab and EKG results on subject safety - How to avoid Protocol Deviations - Importance of good Post-market Pharmacovigilance