Courses and workshops are provided covering the following areas:

  1. Introduction to clinical research & ethics
  2. Investigator GCP responsibilities
  3. Clinical trial regulations (FDA, EMA, local)
  4. Clinical trial organization at study site
  5. Biostatistics for non-statisticians
  6. Protocol design
  7. Medical writing (Protocol, Informed Consent, Final Report, Manuscript)
  8. Audit & inspection readiness
  9. Investigator role as Sponsor in Investigator-initiated studies