This program is an intensive course designed for clinicians who
will be assuming principal investigator responsibilities for clinical trials.
Upon completion of this course, clinicians will be competent and possess the valuable skills needed in order to conduct a well organized and controlled clinical research study within their institution and/or private practices.
9:15-10:00: The Drug Development Process:
10:00-10:45: Principal Investigator Responsibilities
11:00-12:00: FDA Regulations in Clinical Research
CFR Part 11: Electronic Records; Electronic Signatures
Parts Not Reviewed
12:00-12:15: ICH Guidelines for Good Clinical Practice
12:15-1:00: Informed Consent
2:00-2:45: The Clinical Research Protocol
2:45-3:15: Understanding Adverse Events
3:15-3:30: Source Documentation
3:45-4:00: Essential Documents
4:00-4:30: Non-Compliance, Fraud and FDA Suspension
Call or contact us online for course availability and pricing information. Fee includes handbook of materials presented, FDA regulations, Basic Good Clinical Practices