Learn what it really takes to monitor a clinical trial site, from initiation visits and source documentation to adverse event reporting, data review, and inspection readiness. This course covers FDA expectations and sponsor-site interactions, preparing you to plan, execute, and report on monitoring visits with confidence and clarity.
Prerequisites:
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Tue, 01-12-2027 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Tue, 01-19-2027 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Tue, 01-26-2027 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Tue, 02-02-2027 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Tue, 02-09-2027 | 6:00pm | 9:00pm | Live-Online | REMOTE |
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Required Tools & Materials:
ICH E6(R3) guideline, 21 CFR Parts 50/54/56/312, FDA Guidance "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring" (2013)
This will be provided via Canvas by the instructor.
|| Prerequisites:
Prerequisites / Skills Needed
