Catalyst Clinical Services Private Limited

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)