World Conference Calendar

32801 Conferences

Data Monitoring Committees (DMCs) effect on subject safety in clinical research and how to set it up to be effective

Added by Referral on 2010-08-12

Conference Dates:

Start Date Start Date: 2010-10-12
Last Date Last Day: 2010-10-12

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

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
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