This is a professionally developed, interactive and engaging online course suitable for anyone working within clinical trials who wishes to gain an in depth knowledge of audits and inspections. The course describes what investigational medicinal product sponsors, contract research organisations and clinical investigators can expect when they undergo inspection or audit, including the purpose of audits/inspections, benefits and limitations, the auditing/inspection cycle, check lists, data gathering, analysis and interpretation and reports.
Audits are very much part of clinical research and it is vital for individuals and companies to ensure they are audit ready at all times rather than wait until an audit is expected. The course helps to prepare all those working within clinical research to understand the audit process. It will ensure each individual is competent and confident in their role in an audit.
- Understand what an audit/inspection is and the purpose of it within clinical research
- Explore the various types of audits/inspections
- Develop extensive knowledge of the audit process itself, from preparation to report stage
- Learn what the expectations are of you during an audit, and how to successfully navigate the audit process