This educational program is designed and conducted by experienced clinical trial research professionals from within UT Health. The program examines the entire clinical trial process, from planning to trial close-out activities, and provides practical recommendations for increasing the efficiency of clinical trial conduct at investigative sites. This program combines didactic presentations and interactive group sessions. Specific topics include human subject protections, GCP principles, institutional compliance, informed consent process, study initiation, study conduct, FDA inspection, documentation, investigational devices and drugs, reporting requirements, and management systems.
Day 1: Study Approval and Initiation
Day 2: Study Implementation and Monitoring
Day 3: Study Management and Management Systems
**To get the most from this course, please be sure you have completed your CITI Protection of Human Subjects Training.
Objective: To provide a model of practice in conducting clinical research based on the principles of Good Clinical Practice, thereby focusing on research compliance, protecting the safety and well-being of the research subject and ensuring integrity of the research
Audience: Investigators, research nurses, research coordinators.
Location: Cooley University Life Center, 7440 Cambridge St, Houston 77054
Please note course fees for UT Health and MHH participants:
All Three Days - $200
Select Two Days - $150
Select One Day - $75
Course fees for non-UT Health/MHH participants:
Day 3 is not open to outside participants.
Day 1 + 2 - $600
last modified October, 2013
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