Module 1 – Fundamentals of Clinical Research

• Introduction to Clinical Research Industry
• Role of Sponsors, CROs, SMOs
• Clinical Trial Phases (Phase 0–IV)
• Drug Development Lifecycle
• Roles & Responsibilities of CRA
• Key stakeholders in Oncology Trials

Module 2 – Basics of Oncology

• Introduction to Oncology
• Types of Cancer (Solid Tumors vs Hematological Malignancies)
• Cancer Terminology
• Cancer Biology Basics
• Tumor Classification & Staging (TNM staging)
• Biomarkers in Oncology
• Precision Medicine & Targeted Therapy

Module 3 – Oncology Treatment Modalities

• Chemotherapy
• Immunotherapy
• Targeted Therapy
• Hormonal Therapy
• Radiation Therapy
• CAR-T Therapy overview
• Combination Therapies
• Adverse Effects of Oncology Treatments

Module 4 – Oncology Clinical Trial Design

• Oncology Study Designs
• Randomized Controlled Trials
• Adaptive Trial Designs
• Basket Trials & Umbrella Trials
• Dose Escalation Studies (Phase I Oncology Trials)
• Survival Endpoints (OS, PFS, DFS)
• RECIST Criteria (Tumor Response Evaluation)
• Patient Eligibility Criteria

Module 5 – ICH-GCP & Regulatory Guidelines

• Introduction to ICH-GCP E6 (R2)
• FDA & EMA Guidelines
• CDSCO & Indian Regulatory Guidelines
• Ethics Committee Role
• Informed Consent Process (ICF)
• Essential Documents in Clinical Trials
• Investigator Brochure (IB)
• Protocol Review

Module 6 – Role of Oncology CRA

• CRA Responsibilities in Oncology Trials
• Site Feasibility Assessment
• Site Initiation Visits (SIV)
• Monitoring Visits (SMV)
• Close-out Visits (COV)
• Risk Based Monitoring (RBM)
• Source Data Verification (SDV)
• Remote Monitoring

Module 7 – Oncology Safety & Pharmacovigilance

• Adverse Events (AE) & Serious Adverse Events (SAE)
• SUSAR reporting
• Oncology-specific toxicities
• CTCAE grading system
• Safety narratives
• Pharmacovigilance workflow

Module 8 – Clinical Trial Documentation

• Trial Master File (TMF)
• Electronic TMF (eTMF)
• Case Report Forms (CRF & eCRF)
• Site Files & Investigator Site File (ISF)
• Monitoring Visit Reports (MVR)
• Protocol Deviations & Violations

Module 9 – Oncology Data Management

• Clinical Data Management Overview
• EDC Systems (Medidata, Oracle Inform)
• Query Management
• Data Cleaning Process
• Coding Dictionaries (MedDRA, WHO Drug)
• Data review in Oncology Trials

Module 10 – Oncology Endpoints & Assessments

• Tumor Imaging Assessments
• RECIST 1.1 Guidelines
• Biomarker testing
• Survival Analysis basics
• Quality of Life (QoL) endpoints
• Progression assessment

Module 11 – Site Management & Communication

• Site Relationship Management
• Communication with Investigators
• Vendor Coordination
• Lab & Imaging Vendors
• Handling site challenges
• Escalation pathways

Module 12 – Risk Based Monitoring in Oncology

• Centralized monitoring
• Risk identification
• Key Risk Indicators (KRIs)
• Quality tolerance limits
• Monitoring plan preparation

Module 13 – Oncology Protocol Review Workshop

• Reading Oncology Protocols
• Identifying key risk areas
• Eligibility criteria interpretation
• Endpoint understanding
• Case studies

Module 14 – Practical CRA Training

• Monitoring Visit Simulation
• Site Visit Checklist preparation
• SDV practice exercises
• Writing Monitoring Reports
• Query handling exercises
• Audit readiness preparation

Module 15 – Soft Skills for CRA

• Professional communication skills
• Email writing for CRAs
• Interview preparation
• Resume building for CRA roles
• Time management
• Problem solving

Module 16 – Tools Used by Oncology CRA

• CTMS overview
• EDC platforms
• eTMF systems
• Safety databases
• Microsoft Excel for CRAs
• Tracking tools & logs

Module 17 – Career Path & Industry Preparation

• Career progression (CTA → CRA → Sr CRA → Lead CRA)
• Working with CROs vs Sponsors
• Oncology specialization advantages
• Industry certifications
• Job interview Q&A preparation

Course Duration

• 8 to 12 weeks program
• 40 to 60 hours training
• 10+ practical assignments
• Final assessment

Certification

• Course Completion Certificate
• Practical Assessment Certificate
• Internship / Project (optional)