Fremont, California (PressExposure) February 12, 2013 -- Ensuring the safety of participating subjects as well as guaranteeing the integrity of data collected constitutes the cornerstone of clinical research. This "plan" should be at the core of clinical research protocols and should be embedded inseparably into them.
This webinar will offer important insights into how researchers can fulfill these two all-important criteria in the plan. It will take a look at 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices, the defining documents for this field. The nature of the test agent, the vulnerability of the study population, the length of the study and the number of sites conducting the clinical study are the determining factors of this process.
This plan should have the Charter of Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB). The FDA has regulations and the ICH has GCP recommendations concerning DMC's. These are discussed in this session. This webinar will cover the following areas:
o The historical background of why Data and Safety monitoring is essential
o The purpose of the Data and Safety monitoring plan
o The Regulatory requirements for safety monitoring
o Studies requiring a formal Safety Monitoring Committee
o What does the "Charter" of a DMC compose of?
o What is the composition and function of a DMC?
o What types of studies "require" a DMC?
o Importance of avoiding a Conflict of interest in the DMC members
When: March 5, 10:00 AM PDT | 01:00 PM EDT
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research/Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.
Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich.
He has been in the Clinical Research Industry for 20 years, and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training and medical monitoring in both drug and device studies.
The webinar will benefit:
o Pharmaceutical, Biological and device companies with an active pipeline of products and planning on global studies
o Principal Investigators and sub investigators
o Clinical Research Scientists
o Research Managers
o Safety Nurses
o Clinical Research Associates (CRAs) and Coordinators (CRCs)
o Recruiting Staff
o QA/QC Auditors and staff
o Study Monitors
o Clinical Research Data managers
Duration: 90 minutes
To enroll for this webinar, contact