Courses and workshops are provided covering the following areas:
- Introduction to clinical research & ethics
- Investigator GCP responsibilities
- Clinical trial regulations (FDA, EMA, local)
- Clinical trial organization at study site
- Biostatistics for non-statisticians
- Protocol design
- Medical writing (Protocol, Informed Consent, Final Report, Manuscript)
- Audit & inspection readiness
- Investigator role as Sponsor in Investigator-initiated studies
