CT: Monitoring Oncology Trials

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.