Monitoring Clinical Trials for GCP Compliance

GP Pharm Medical offers coursers on Monitoring Clinical Trials for GCP Compliance. The course covers all basic and necessary issues of managing, conducting and monitoring clinical trials. This is the most popular course organised in Poland and abroad.

 

PROGRAMME

  1. Principles of obtaingning new medicinal products. Methodology of pharmacological research.
  2. Pre-clinical trials
  3. Clinical trials
    1. The aim of clinical trials
    2. Phases of clinical trials
    3. Characteristics and glossary
    4. Sponsor
    5. CRO
    6. CRA
    7. SMO
    8. Investigator/ Institution
    9. Bioethics Committee
    10. EMEA
    11. FDA
  4. Declaration of Helsinki
  5. Good Clinical Practice (ICH-GCP)
    1. Role and responsibilities of sponsors
    2. Role and responsibilities of investigators
    3. Role and responsibilities of monitors
  6. Adverse events
    1. Definitions and categories of adverse events in clinical trials
    2. Adverse Events Reporting
  7. Clinical trial reports
    1. Protocol
    2. Informed consent
    3. Investigator's brochure
    4. Case report form
    5. Source data
    6. Administration data: "Trial investigator's file", "Trial master file"