Monitoring oncology clinical trials requires advanced skills, including understanding and maintaining complete regulatory documents; protocol & data integrity; patient safety; and the successful completion of the clinical trial within the sponsor’s/CRO’s and medical site’s goals, all within the framework of good clinical practices (GCPs). Students are exposed to key regulatory documents, IND safety reports, MedWatch reports, various IRB submissions/requirements, and federal guidelines. Also covered: responsibilities of clinical research personnel; correlation of concomitant medications; tumor assessments; assessing and grading toxicities; cancer-specific SAE; & SAE reporting.
Other Credits: BRN: 27 CE hours.
Note: Prerequisites: Understanding Oncology (FPM-40493) and Nuts & Bolts of Monitoring Clinical Trials (FPM-40187). Elective for Professional Certificate.
Course Number: FPM-40494
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management
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2/1/2021 - 3/14/2021
$545
Online
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CLASS TYPE:
Online Asynchronous.
All instruction and course materials delivered and completed online between the published course start and end dates.
INSTRUCTOR:
Kosits, Cheryl, Moores UC San Diego Cancer Center
Moores UC San Diego Cancer Center
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TEXTBOOKS:
No information available at this time.
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NOTE:
Refund deadline: one week after enrollment or start date of section, whichever is later.
2/1/2021 - 3/14/2021
extensioncanvas.ucsd.edu
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or unexhealthcare@ucsd.edu for information about when this course will be offered again.