• Principles and background of ICH Good Clinical Practice (GCP)
• Responsibilities of the Sponsor according to section 5 of ICH GCP in all stages of the trial
• Ethical and scientific quality standards that lead to reliable trial results
• Quality management, internal quality controls, and quality assurance during the trial set-up
• Sponsor’s involvement in gathering data and preparing documents to submit to the IRB/IEC, the reviewing committee
• Ethical review that happens prior to the first subject entering a trial
• Sponsor’s role during the trial including monitoring the quality of the conduct of the trial, IP Management, Safety, and quality controls
• Requirements for closing the trial and archiving

TRAINING OBJECTIVES EU CTR FOUNDATION

• Goal EU CTR and difference between a Directive and Regulation
• Scope of EU CTR: to which type of research is the EU CTR applicable?
• High-level contents of the EU CTR
• Opportunities, benefits, and challenges of the EU CTRand submissions via the CTIS portal
• When will the EU CTR be implemented and what does the transition period look like?
• Timelines of the submission- and review process according to the EU CTR regulation
• Differences in the submission of a national trial and an international trial
• Results of the validation phase, Assessment part I and assessment part II
• Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials