Catalyst Clinical Services Pvt Ltd

Other Details

Oncology Clinical Trials Training provide the candidates with expertise to conduct studies and research to find better ways to treat cancer and enhance the overall cancer care standards. We provide highly detailed Oncology Clinical Trials Training (OCTT). The key features of our programs are:

    Skill Development Program
    Duration is 12 weeks
    Imparted through Correspondence
    Major focus on Management of Oncology Clinical Trials

Eligibility:

All working professional who have competed the following degree courses and diplomas are eligible for the OCTT course. Final year students, completing their courses this year can also apply for enrolment in the program.

    B.Pharm, M.Pharm, Ph.D
    M.B.B.S, M.D, M.S, D.N.B, D.M
    B.D.S, M.D.S, B.P.T, B.Tech
    B.A.M.S, B.H.M.S, B.U.M.S
    B.Sc, M.Sc, Ph.D

A large number of our candidates have successfully completed our OCTT course and are now skilled Oncology Trials Researchers. The main objectives of the training program are:

    To provide the relevant skills and knowledge essential for carrying out oncology clinical trials
    To give in-depth and comprehensive training on management and monitoring of oncology clinical trials
    To recognize and respond to the key challenges innate to the oncology clinical trial process

The Oncology Clinical Trials Training Program is spread across Three Modules that have to be completed within the 3 months duration. The list of the components covered under the three modules is as follows:
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)