Catalyst Clinical Services Pvt Ltd

Other Details

Our Professional Diploma in Clinical Research arms our candidates with knowledge and skills to understand the fundamentals and essentials of Clinical Research, helping them to carry our researches that determine effectiveness, safety and side effects of new drugs and treatments. The details of the various components of the 4 course modules are:

Module-I: Introduction to Pharmaceutical Medicine

    The Drug Development Process
    New Drug Discovery
    Clinical Development of Drug
    Essential Clinical Trial Documents
    Clinical Trials Terminology

Module-II: Good Clinical Practice (GCP) Foundations

    History of GCP - milestones in the evolution of GCP
    Principles of GCP
    Applicable GCP Guidelines
    Declaration of Helsinki
    Clinical Study Process
    The Management of Clinical Studies (Sponsor)
    Ethics in Clinical Research
    Informed Consent
    Serious Adverse Event (SAE)
    Challenges in the Implementation of GCP Guidelines
    Biostatistics

Module-III: Drug Regulatory Affairs (Clinical Trials)

    Overview of Regulatory Environment in USA, Australia, Europe and India 
    Clinical Trial Application Requirements in India
    Import- Export of Clinical Trial Drugs in India
    Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

IND/ANDA/New Drug Application

Module-IV: Roles and Responsibilities of Clinical Trial Personnel

    Roles and Responsibilities of Sponsor
    Roles and Responsibilities of Investigator
    Roles and Responsibilities of ERB/IRB/IEC
    Roles and Responsibilities of CRA /Monitor
    Roles and Responsibilities of Auditor
    Roles and Responsibilities of Clinical Research Coordinator or Site Manager
    Roles and Responsibilities of CRO’s
    Roles and Responsibilities of Regulatory Authorities
    Roles and Responsibilities of Clinical Data Manager (CDM)
    Roles and Responsibilities of Clinical Biostatistician