Adhering to Good Clinical Practice: An Overview of Clinical Trials
Wednesday, May 31, 2013 | ARCHIVE NOW AVAILABLE
Conducting clinical trials is not just treating patients—it is a controlled experiment with regulations to be followed. During the conduct of research involving human subjects, it is critical to adhere to principles of good clinical practice (GCP) and human subject protection (HSP). Good clinical practice is an international scientific and ethical quality standard for the design, conduct, execution, monitoring, auditing, recording, analysis, and reporting of all clinical trials that involve human subjects to ensure:
• Protection of rights and safety of human subjects
• Consistency with the Declaration of Helsinki
• Accuracy and credibility of clinical trial data
After this presentation you should be able to:
• Understand the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) and additional regulations for the conduction of clinical trials
• Apply GCP standards and implement them at your clinical trial site(s)
• Understand informed consent and ethics
• Understand safety reporting and monitoring
• Identify individual roles and responsibilities of personnel involved in clinical trials
• Understand essential documents for clinical trial conduct
• Understand how to set up a clinical study that complies with GCP and ensure that data is collected efficiently with high quality
• Prepare for a GCP audit
A live Q&A with the audience will follow the main presentation.
Jeremy Lim, Pharm.D.,Fellow, Clinical Development, Novartis Pharmaceuticals Corporation
Dr. Jeremy Lim earned his PharmD from the University of the Pacific, Thomas J. Long School of Pharmacy and Health Sciences in Stockton, California, USA and is now a Post-Doctoral Fellow in Clinical Development at Novartis Pharmaceuticals Corporation under the Rutgers Institute for Pharmaceutical Industry Fellowships. He is a licensed pharmacist in California and currently functions as a Senior Clinical Manager/Clinical Scientist leading phase II and III clinical trials in psychiatry and tropical medicines. Dr. Lim has gained a wealth of experience in clinical operations, clinical development strategies, clinical submission reports, ICH/GCP, and protocol development. He is adjunct faculty at Rutgers University Ernest Mario School of Pharmacy and has been invited to give career presentations at various universities in the United States.
Dr. Lim’s initial training was in cardiovascular research at David Grant United States Air Force Medical Center in Travis, California, USA serving as a subject matter expert in Enhanced External Counterpulsation (EECP), grant writing, and clinical study design.