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Cancer and Treatment Goals
- Understand the characteristics of cell formation, the major causes of cancer and global impact of the disease
- Examine the impact of Oncology studies and current treatment
- Be able to discuss available treatments and objectives of treating cancer
Cancer Treatments
- Examine various cancer treatments and their adverse reactions
- Explore alternative treatment options
Chemotherapy and Radiation
- Identify common cancer drug and cancer combinations
- Thoroughly understand the relationship between risk and benefits of tumor therapies
- Recognize chemotherapy drug types and different principles
Tumor Staging and Tumor Grading
- Differentiate between cancer and uncontrolled tumor growths
- Recognize the six major categories of cancer classifications
- Understand components of medical terminology related to cancer
Oncology Study Design
- Be able to discuss Oncology trial schematics and understand the design features.
- Be able to describe the four phases of Oncology studies.
- Understand Endpoint requirements in Oncology
Clinical Assessments
- Recognize common clinical assessments related to oncology trials
- Gain proficiency in reviewing clinical reports
- Identify disease history and common Inclusion/Exclusion criterion
Lines of Therapies
- Define each line of therapy and understand the timing of each line
- Understand dosing design in oncology studies
Adverse Events, DLTs and Dose Modifications
- Recognize most common Adverse Events and be able to discuss clinical events related to oncology studies
- Recognize common toxicities and understand the DLT process
Identifying Oncology Subjects and Enrollment Process
- Be able to discuss recruitment challenges in Oncology studies
- Describe the screening and enrollment process
- Understand the role of the medical monitor and various key members during screening process
Source Documents and Clinical Reports
- Pathology
- Radiology
- Clinical Reports and Source
- Medical
- Surgical
RECIST 1.0, RECIST 1.1
- Distinguish between RECIST 1.0 and RECIST 1.1
- Utilize appropriate oncology disease progression algorithms
- Understand disease progression
Oncology Site and Delegation Log
- Prepare for challenges with site structure and Delegation of Responsibility at oncology sites
- Describe key site staff and associated roles
- Discuss the key function of site staff
The Oncology Monitor
- Learn Sponsor/CRO expectations of Oncology Monitors
- Understand the stress and pressures of monitoring oncology studies
- Learn time saving techniques while monitoring
Our Expert Instructors
Vince W
CRA Instructor
Cynthia L
CRA Instructor
Jessie C
CRA Instructor
Lauren M
CRA Instructor
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