As part of the JRCO sponsor remit to demonstrate oversight and project research compliance we may audit research studies at any time. If your project is selected for audit then we will contact you with more information regarding what an audit will entail.
You may also request a voluntary audit if you wish to check compliance of your study.
Normally the audit process takes around a day with 2-3 auditors and will involve assessment of the projects Trial Master File, CRFs, facilities and source data verification. The audit will check that the study is running to ICH GCP guidelines and any other applicable regulatory requirements.
In some cases an audit may be triggered if concerns are raised regarding a research project or a breach of GCP has been identified.
Please be assured we will make sure that any audit fits in with your commitments and priorities.