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    Best Clinical Data Management Courses in Pune

    BY
    TechnoBridge

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    Mode

    Online

    Duration

    1 Months

    Quick Facts

    particular details
    Medium of instructions English
    Mode of learning Self study
    Mode of Delivery Video and Text Based

    Course and certificate fees

    certificate availability

    Yes

    certificate providing authority

    TechnoBridge

    The syllabus

    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

    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

    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

    Drug Development Process

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

    Clinical Data Management

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

    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

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