Method
Live-Online
Term
SUMMER
Units
1.5 QUARTER UNITS
Cost
$625
Course Description
This course presents the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The course covers expectations of the FDA, the sponsor, and the site. The process of site selection, budgeting, initiation visits, source documentation, regulatory documentation, and adverse event reporting are additional topics covered. Included in the course are the process of medical record review and maintenance, case report form completion, product accountability, and various tasks associated with different monitoring visits.
Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.
*This course may be applied to a certificate only if you are currently declared in a program.
Prerequisites / Skills Needed
Prerequisites:
- CTDM.X411: Good Clinical Practices
You may enroll in this offering at any time.
Jul. 25 - Aug. 22, Wed, Sat, 9:00am - 12:00pm
- Live-Online Attend via Zoom at scheduled times.
CTDM.X404.(8)
Schedule
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Sat, 07-25-2026 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 08-01-2026 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 08-08-2026 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 08-15-2026 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 08-22-2026 | 9:00am | 12:00pm | 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.
|| Prerequisites:
Prerequisites / Skills Needed
This course applies to these programs:
