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.
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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4/6/2020 - 6/12/2020
7/6/2020 - 8/30/2020