Medical Research Management - Monitoring Oncology Trials

Course Description

Advanced therapeutic area training is essential for monitors working on complex oncology trials. This 3-day course prepares CRAs for the challenges of monitoring in the oncology field. The course begins with an overview of the pathology, diagnosis and treatment of cancer. Next, the course will explore the design and management of oncology trials. Finally, students will apply the MRM Step Method™ to oncology case studies. This course is designed for CRAs with a minimum of 6 months monitoring experience, but is open to all students.

Course Objectives

Describe an overview of the Oncology therapeutic area.
Identify techniques in monitoring safety data using the CTCAE grading with the source.
Discuss the oncology monitoring method and tools to permit a systematic approach to complex trials.
List common GCP issues and methods of securing compliance.

Daily Agenda / Course Topics

Day 1

I. Oncologoy Overview

INTRODUCTION TO CANCER: Overview of Investigation Product Development, FDA & ICH GCP obligations.
DIAGNOSIS: The Types of Clinical Research Audits
The Auditing System and the Audit Plan
- Staging
- Treatment
- Follw-up

II. Oncology Trials

Inclusion/Exclusion Criteria
Endpoints
Dose Modifications & Holds
Common AEs & Toxicities
Pediatric Trails
Regulatory & GCP Obligations

III. Monitoring Oncology Trials

Monitor Method & Tools
Documentation & ALCOA
EMR Auditing
Informed Consent
Monitoring Medications & Dosing
Monitoring AEs & Toxicities: CTCAE Grading & Special Data Handling

IV. Hands-on Monitoring Activity

Who Should Take This Course

This course is designed for individuals with a minimum of 6 months clinical research experience. CRAs that do not have formal training, but are interested in learning skills that will enhance their monitoring activities and those who are transitioning into a CRA position will benefit from this course.

Dates / Times / Accommodations

Seminar Dates	Seminar Location	Seminar Time	Seminar Fees
Register by Phone: 877-633-3322 OR Print Application (pdf) and Fax To: 954-346-2791		Accommodations Ask About Student Discount (Availability limited)

Contact Hours

Florida State provider #50-11408, provider approved by the California board of registered nursing, provider #CEP 13617 for 16.5 contact hours. credits can be applied to acrp certification.

Cancellations and Substitutions

Cancellations by registrants must be provided in writing prior to the start date of the seminar, such registrants shall receive a credit voucher toward a future MRM seminar. Companies may substitute someone registered with another participant at any time. MRM reserves the right to cancel a seminar due to poor enrollment or acts of nature and shall not be responsible for any airfare, hotel, or other costs. MRM shall offer a credit voucher to a future seminar or a complete refund for MRM Seminar cancellations. Seminar topics and speakers may be subject to change without any prior notice.