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.

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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4/19/2021 - 6/4/2021

$545

Online

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• SECTION ID:

  153615

• 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

• TEXTBOOKS:

  No textbook required.

• POLICIES:

• NOTE:

  Refund deadline: one week after enrollment or start dat e of section, whichever is later.

• DATE & LOCATION:

  4/19/2021 - 6/4/2021
  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.