The course will provide an introduction to auditing clinical development documents such as protocols, case report forms (CRFs), informed consents, clinical study reports and investigator brochures
This ½ -day course is designed to provide you with the tools to carry out audits of key clinical development documents.
Why is this important?
Document audits, especially in smaller companies which do not yet have established processes in place, should form an essential part of quality assurance activities.
Documents are key to the whole clinical development process, starting with the investigator brochure and moving on to protocols, case report forms, informed consents and clinical study reports. It these are deficient; the quality of your clinical trials could be called into question.
These audits are relatively straightforward and can be conducted in-house.
They will provide added-value to your clinical development process.
Course time½ Day: 09h00 – 13h00
Who should attend
This course is designed for clinical research professionals with previous working experience in a GCP or in a Quality Assurance environment and who wish to learn the basics of how to audit clinical development documents.
Auditing experience is not required.
- Document audit concepts
- Approaches to planning and conducting document audits
- Reporting audit findings
- Audit follow-up and CAPA plans
- Understand the added value of document audits within the quality assurance system
- Be familiar with applicable standards for document audits
- Prepare for document audits
- Conduct document audits
- Present observations and write audit reports
- Recognize the importance of document audit follow-up / CAPA plans
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained