
Specialized Training for Excellence in Oncology Clinical Trials
The Oncology Clinical Trials Training (OCTT) program is a specialized, competency-driven course designed to equip participants with the knowledge, skills, and practical expertise required to manage and oversee oncology clinical trials. The program focuses on the unique scientific, operational, and regulatory complexities of cancer research, enabling learners to develop proficiency in oncology trial conduct through a structured and hands-on training approach.
Structured as a six-month, distance-learning program, the course offers the flexibility of a self-paced format, enabling participants to complete the training within a typical 3-6 month timeframe. Learners are provided with two comprehensive self-learning modules, an assignment workbook, and hands-on training materials designed to ensuring a strong foundation in oncology-specific clinical research principles.
Practical training is reinforced through realistic case studies and a detailed dummy clinical trial monitoring kit, which includes a protocol synopsis, Case Report Forms (CRFs), source documents, and an Investigator Site File (ISF). Learners are required to critically review these materials and identify intentionally embedded deficiencies, closely simulating real-world oncology trial oversight scenarios.
Successful completion of all required assessments and fulfilment of the minimum qualification criteria, participants are awarded a professional certificate, recognizing their readiness to contribute effectively to oncology clinical trial operations and monitoring.
What you'll learn
Oncology trial fundamentals and ethics/consent
Cancer staging, endpoints, and assessment standards
Safety and efficacy evaluation using WHO/RECIST
Oncology-specific monitoring and SDV practices
IP accountability, SAE handling, and deviation control
Oncology site close-out with complete ISF/CRF quality
Why choose this Course?
Self-Paced Learning
Flexible format that fits around professional or academic schedules.
24/7 Expert Academic Support
24/7 faculty guidance for queries, feedback, and learning clarity.
Industry-Ready Content
Curriculum mapped to current industry practices and GCP standards.
A Standout Portfolio
Assignments that showcase trial design and operational know-how.
Real-World Projects & Case Studies
Applied real-world case studies reflecting actual scenarios.
Placement Assistance
Career guidance and interview readiness for industry roles.
Course Details
Module 1: Fundamentals of Oncology Clinical Trials
Duration: Self-Paced
Topic Covered
Introduction to Drug Discovery Process
Guidelines and Standards Governing Clinical Research
Essential Clinical Trial Documents
Ethics Committee/Ethics Review Board
Informed Consent Process
Overview of Cancer and Oncology Clinical Trials
Diagnosing Cancer: Staging and Disease Assessment
Safety Evaluation in Oncology Clinical Trials (WHO, CTC)
Efficacy Evaluation in Oncology Clinical Trials (WHO, SWOG, RECIST)
Glossary
Skills Acquired
Oncology trial fundamentals
Ethics and EC processes
Cancer staging and assessment
Safety and efficacy evaluation standards
Clinical documentation essentials
Module 2: Oncology Clinical Trials Monitoring
Duration: Self-Paced
Topic Covered
Development of a Monitoring Plan
Site Initiation, Review of Essential Trial Documents, Delegation of Duties and Responsibilities at Individual Site
Clinical Trial Monitoring
Inventory Planning and Tracking
Source Document Verification (SDV)
CRF Review, and Coordination of Data Management Activities
Serious Adverse Event (SAE) review and Regulatory Compliance
Investigational Product (IP) Accountability and Management
Management and Prevention of Deviations
Site Closure Monitoring Visit
Skills Acquired
Oncology monitoring plan design
Site initiation for oncology studies
SDV and CRA practice
IP accountability and tracking
Deviation management and site closure
Module 3: Hands-on Training
Duration: Self-Paced
Topic Covered
Review a simulated oncology clinical trial monitoring kit and accurately complete oncology-specific Case Report Forms (CRFs)
Conduct an oncology trial monitoring visit and systematically identify, assess, and document discrepancies or protocol deviations
Identify and evaluate discrepancies or deviations within the Investigator Site File (ISF) in the context of oncology clinical trials
Skills Acquired
Oncology CRF completion
Monitoring visit execution
Protocol deviation detection
Oncology ISF quality review
Course Schedule
1
Receive Study Material
Upon registration, you will receive four comprehensive Learning Modules along with an Assignment Workbook.
2
Study & Complete Assignments
Go through the modules and complete the assignments within the standard 4.5-month duration.
3
Option for Early Completion
If you wish to finish sooner, you may submit your completed workbook with an early assessment request.
4
Assessment
Your Assignment workbook is evaluated based on the qualification criteria.
5
Earn Your Certificate
After successful assessment, you will be awarded a Certificate of Completion.
Registration Process
Three-step registration process:
1
Get the Registration Link/QR
Receive the registration link and QR code from us.
2
Complete the Form & Payment
Fill out the registration form and pay the course fee using the QR code.
3
Receive Confirmation
Get an acknowledgement call confirming your successful registration.
Program Fee
Indian Participants
₹14000
Foreign Participants
$350
This course includes
Duration
Self-Paced
Lessons
4
Students
500+
Language
English
Certificate
Yes
Contact for more details of the course
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