Oncology Clinical Trials Training is a skill development program (through correspondence) of 12 weeks duration with a primary focus on Management of Oncology Clinical Trials.

The objectives of the training program are:

•    To arm clinical research professionals with the knowledge and skills required for carrying out oncology clinical trials.
•    To provide an in-depth training on monitoring and management of oncology clinical trials.
•    To identify and answer the major challenges that is seemingly inherent to the oncology clinical trial process.

The Oncology Clinical Trials Training Program consists of Three Modules with following components:

Module-I: Fundamentals of Oncology Clinical Trials

•    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)

Module-II: Oncology Clinical Trials Monitoring

•    Development of Monitoring Plan
•    Site Initiation Visit, Review of Essential Trial Documents, Delegation of Duties at Individual Site
•    Routine Monitoring Visit
•    Inventory Planning and Tracking
•    Source Document Verification (SDV)
•    CRF Review, Collection and Coordination of Data Management Activities
•    Serious Adverse Event (SAE) review and Regulatory Compliance
•    Investigational Product Accountability and Management
•    Escalation, Management and Prevention of Violations/Deviations
•    Tracking of Enrolments, Payments and Ongoing Correspondence
•    Site Closure Monitoring Visit

Module-III: ‘Dummy Clinical Trial Monitoring Kit’

•    Protocol
•    Source Document
•    Informed Consent Document (ICD)
•    Case Report Form (CRF)

Duration : 3 Months

Fees : 15000