Event Description
This three-hour course will provide staff and students with the necessary skills and knowledge to carry out high quality research and to satisfy the requirements of R&D departments.
By the end of this course you will be able to:
- Understand the guidance that is relevant to your work
- Be aware of the changes to the ethics process and the definition and responsibilities of the Sponsor and Investigator
- Understand the requirements for Informed Consent
- Understand the processes and significance of Pharmacovigilance / Safety Reporting
- Define an Essential Document and understand the requirements for clinical trial documentation and data quality at the trial site
- Understand what a monitor, auditor or inspector will look for when visiting a site
Please note.This course does not meet the minimum training requirements for CTIMP studies. Therefore, if you are subsequently required to work on CTIMP studies, you will need to attend the CTIMP GCP Training Course.