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Clinical trial monitoring is a critical component of oncology research, join us on this journey to become a proficient oncology clinical trial monitor, and contribute to advancing cancer treatments and improving patient outcomes. The global oncology market size has been substantially growing and was valued at USD 222.36 billion in 2023 and is poised to grow from USD 242.15 billion in 2024 to USD 521.60 billion by 2033, growing at a CAGR of 8.9% in the forecast period (2024-2033). - Apr. 16, 2024
This online and self-paced program is designed to provide you with a comprehensive understanding of the critical role that clinical trial monitoring plays in oncology research. Students will be provided with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed. This curriculum is designed to provide a balanced combination of theoretical knowledge and practical skills, preparing participants to effectively contribute to cancer clinical research. After passing the final exam, an oncology clinical trial monitoring certificate will be provided to the successful candidate.
By the end of Oncology Clinical Trial Monitoring course , graduates will be able to :
Understanding Cancer Biology and Treatment
Identify the different types of cancers and their characteristics.
Familiarity with Oncology Treatments
Explain standard and emerging cancer therapies, including chemotherapy, radiation, immunotherapy, and targeted treatments and understand the role of precision medicine and biomarkers in cancer treatment.
Develop Expertise in Oncology Trials
Gain a deep understanding of the unique challenges and requirements associated with monitoring clinical trials in oncology.
Enhance Monitoring Skills
Learn the essential skills needed to effectively monitor oncology trials, including protocol adherence, data verification, patient safety oversight, and regulatory compliance.
Differentiate between RECIST 1.0 and 1.1
Why is being used in the clinical trial you are assigned/monitor
Define Oncology Endpoints
Understands how, when, and why Endpoints Matter, what the path to approval is, and what the new approval designations mean.
Learn Critical Thinking and Decision-Making
Analyze complex situations in cancer clinical research and develop solutions. You will engage with real-world case studies, practical exercises to apply your learning in practical scenarios. This course will equip you with the knowledge and skills to make a meaningful impact in the field of cancer research.
A comprehensive cancer clinical research curriculum covers a wide range of topics to prepare you for critical monitoring roles in this specialized field. Here's an outline of what such a program include :
Introduction to clinical research methodologies, including phases of clinical trials and study design.
Overview of regulatory agencies (e.g., FDA), ethical guidelines (e.g., ICH GCP), and institutional review boards (IRBs).
Understanding the biology of cancer, including tumor formation, progression, and metastasis.
Overview of different cancer types, their molecular characteristics, and staging systems.
In-depth exploration of the design and planning of cancer clinical trials, including the development of research protocols.
Considerations for patient populations, eligibility criteria, endpoints, and control groups.
Ethical dilemmas in cancer clinical trials, including issues related to informed consent, vulnerable populations, and placebo-controlled trials.
Comprehensive understanding of regulatory requirements and compliance in oncology research.
Strategies for recruiting and retaining participants in cancer clinical trials, considering the unique challenges in oncology research.
Effective communication and informed consent processes specific to cancer trials.
Overview of various cancer treatment options, including surgery, chemotherapy, radiation therapy, immunotherapy, and targeted therapies.
Understanding the mechanisms of action and side effects of cancer treatments.
Data collection and management specific to oncology trials, including Electronic Data Capture (EDC) systems.
Quality control and data integrity in cancer research.
In-depth knowledge of adverse event reporting, especially related to cancer treatment toxicities.
Safety monitoring and management in oncology trials, including the use of the Common Terminology Criteria for Adverse Events (CTCAE).
Practical skills for conducting site visits, data monitoring, and source document verification in cancer clinical trials.
Risk-based monitoring (RBM) approaches and centralized monitoring in oncology research.
Understanding the emerging field of cancer immunotherapy and personalized medicine.
Implications for clinical trial design and monitoring.
Preparing regulatory submissions, including Investigational New Drug (IND) applications for cancer therapies.
Maintaining essential regulatory documentation, including Investigator Site Files (ISF).
Collaboration with oncologists, pathologists, radiologists, and other healthcare professionals in a multidisciplinary team.
Effective communication and teamwork in oncology research.
The role of ethics committees in cancer research.
The importance of patient advocacy and support services in oncology trials.
Guidance on career paths in cancer clinical research, including roles as Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and Principal Investigators.
Staying updated with industry trends and emerging technologies in oncology research.
Real-life case studies and hands-on experience, including site visits and mock monitoring visits.
Analyzing real-world scenarios and applying knowledge to practical challenges
This is a well - rounded cancer clinical research curriculum combines theoretical knowledge with practical skills and real-world experience to prepare you for careers in oncology research. It also emphasizes the importance of patient safety, ethical conduct, and compliance with regulatory standards in cancer clinical trials.
