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  1. Overview of Clinical Research
    1. Who/What/Why/Where of Clinical Research
      • Clinical research defined
      • Definitions and Terminologies of Clinical Research
    2. Developing Clinical Research Questions/Hypothesis
      • Drug Development Process
      • ICH- GCP, US-FDA, EMEA, TGA, ICMR, Schedule Y Etc……
    3. Ethics of Clinical Research

  2. Principles of Pharmacology & Drug Discovery & Development
    • BA and BE Studies
    • ADME Studies

  3. Clinical Trial Design
    • Types of Clinical Trial Designs
    • Clinical Trials
    • Observational
    • Descriptive
    • Case Studies

  4. Clinical Trial Protocol
    • Types
    • Techniques
    • Significance

  5. . Research subjects
    • Identify
    • Verify
    • Recruit
    • Consent

  6. Study organization and Management Forms
    • Outcomes, co-variants, sample size, analytical plans
    • Measures/Instruments
    • Data Presentation and Appraisal

  7. Quality assurance in clinical trials
    • SOPS
    • Monitoring
    • inspections and audits
    • address of audit findings and its resolution
    • Responsibilities according to GCP, GCP compliance

  8. Clinical Data Management, Biostatistics, Analysis & Reporting
    • Data Capture
    • Data Collection
    • Data Verification and cleaning

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