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    Clinical Research Courses in Pune

    BY
    TechnoBridge

    Brochure Enquire
    Mode

    Part time, Online

    Duration

    3 Months

    Fees

    ₹ 25,000

    Quick facts

    particular details
    Medium of instructions English
    Mode of learning Self study, Virtual Classroom +1 more
    Mode of Delivery Video and Text Based

    Course and certificate fees

    Fees information

    ₹ 25,000

    certificate availability

    Yes

    certificate providing authority

    TechnoBridge

    The syllabus

    Module 1 - Introduction to Clinical Research

    • Introduction to Clinical Research
    • Terminologies in Clinical Research
    • Advantages of CR in India
    • Introduction to Clinical Research- Notes
    • Introduction to Clinical Research Quiz

    Module 2 -Good Clinical Practice (GCP)-ICH E6

    • History Development of International Regulations in Clinical Research
    • Good Clinical Practices
    • Ethics committee
    • Investigator Responsibilities
    • Sponsor Responsibilities
    • Protocol and Investigator Brochure
    • Essential Documents

    Module 3 - Pharmacovigilance

    • Adverse Event Reporting
    • Recording of Event
    • Medical Management of Adverse Events
    • Handling Death
    • Unblinding of Drug
    • Clinical Safety and Pharmacovigilance
    • E2A- Clinical Safety and Data Management
    • Media 436
    • Naranjo Assessment
    • Order and Formulate to Determine the Quantum

    Module 4 - Monitoring of Trials

    • Audits and Inspections
    • Flow of Events
    • Investigational Drug Management
    • Routine Monitoring Visits
    • Site Visit Flow

    Module 5 - Drug Development Process

    • Overview of Drug Development
    • Clinical trial phases
    • BA/BE Studies
    • Drug Development Notes
    • Drug Development Quiz

    Module 6 - Clinical Data Management

    • CFR Part 11
    • CRF_Design_2
    • Introduction to CDM
    • Data Entry Methods
    • Query Management
    • Source data validation
    • Future of Data Management

    Module 7 - Regulatory Affairs

    • Application of Permission
    • Approval of Clinical Trial
    • CDSCO
    • Code of Federal Regulation (CFR)
    • CT_Rules_2019
    • ICMR Guidelines
    • Medical Devices
    • ICMR Guidelines
    • DoH Oct 2013
    • Guidelines for Industry

    Module 8 - Protocol Designing

    • Drafting a study protocol
    • Study Design
    • Informed Consent
    • Design of Trial- Notes
    • Protocol Designing- Quiz

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