Core Java

Clinical

Research


What is CLINICAL RESEARCH?

Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. Also called clinical study and clinical investigation. Note that in this manual, this term is used in its narrow sense as used by the FDA. Thus, it does not encompass all the research that is carried out in the clinical setting (e.g., health services research).

COURSE CONTENT
  • What is Clinical Research?
  • Types of Clinical Research
  • Drug Discovery and Drug Development Process
  • Innovator Drug and Generic Drug
  • ANDA
  • Evolution of Ethics
  • Regulatory Authorities
  • IRB/IEC
  • ICH GCP
  • Clnical Trial Team and their Responsibilities
  • CLINICAL RESEARCH ASSOCIATE (CRA)
    • Preparing for the study
    • Study Initiation
    • Study Monitoring
    • AE & Safety Monitoring
    • Recruitment, Retention & Compliance
    • Study Closeout
    • Error, Misconduct & Frauds 
  • CLINICAL RESEARCH COORDINATOR (CRC)

    • Planning stages & commencements of the study
    • Interaction with sponsor
    • Interactions within the Institution
    • Role of study subjects
    • Data Management
    • Adverse Event
    • Investigational Agent Management
  • Protocol
  • Informed Consent
  • Case Report Forms
  • Code of Federal Regulation
  • Investigator's Brochure
  • Investigational Product
  • SOP's
  • Clinical Study Report
  • Essential Trial Documents
  • Audit
  • Terminology

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