Auditing Clinical Development Documents
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 11/09/2025 | Auditing Clinical Development Documents | EUR 625 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
The Auditing clinical development documents course will provide an introduction to auditing clinical development documents such as protocols, case report forms (CRFs), informed consents, clinical study reports and investigator brochuresWhat's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1/2-Day face-to-face: 13:00 - 17:00 | Online: 1 webinar session of 3 hours |
Course Long Description
This Auditing clinical development documents 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. If 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.Programme highlight
- Document audit concepts
- Approaches to planning and conducting document audits
- Reporting audit findings
- Audit follow-up and CAPA plans
Learning objectives
- 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
Who should attend
This Auditing clinical development documents 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.Competencies
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 ()
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