Clinical Trials: Good Clinical Practice
The ICH E6 GCP Investigator Site Training meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Clinical Operations:
Design and Conduct of Clinical Trials; Clinical Trials Data Management and Quality Assurance
Clinical Trials Management and Advanced Operations; Clinical Trials Analysis, Monitoring and Presentation
Clinical Trial Regulation EU 536/2014 in Clinical Research
The documentation, submission process and strategy for Part I and Part II for all application types.
Design and Interpretation of Clinical Trials
Trial Types; Randomisation and Masking; Outcomes and Analysis; Ethics; Reporting Results; Randomised Clinical Trials vs Observational Trials.
