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.