EFGCP Interactive Investigator Training for Inspections
This one-day course is aimed at clinical trial centre staff such as investigators, co-investigators, study nurses and coordinators and anyone who is involved in the conduct of clinical trials of any phase and design, sponsored by commercial or academic institutions. Inspections are no longer linked to a submission by a sponsor to Health Authorities to obtain a marketing authorization but in the today’s inspection landscape inspections can occur at any time with and without a particular event triggering these. Especially in Europe, Health Authorities conduct inspections as part of their routine oversight activity. For clinical trial centre staff it is, therefore, important to understand what is required during an inspection, how to prepare for and follow-up on an inspection. It is also important to understand and apply new trends such as the concept of a risk based approach that is becoming the reference for inspectors.
The topics covered in this course include:
Preparation for an announced inspection
Managing the inspection itself
Responding to questions and requests for documents
Responding to the inspection report
Producing a corrective and preventative action plan
This Training Course is provided by members of the Audit Working Party which is a sub-group of the European Forum for Good Clinical Practice, with an interest in QA of clinical trials. Members have a great deal of experience of facilitating regulatory inspections, and it was agreed to share this experience with investigator site staff and others.
If you would like more information, do not hesitate to contact Fanny Senez at the EFGCP Secretariat: firstname.lastname@example.org or tel: +32.2.732 87 83