Select Series: Helpful Information from BRANY’s Quality Assurance Team Regulatory Documents
Is your study’s regulatory binder up-to-date and audit ready? You may have all the IRB submissions and approvals on file along with protocols, IBs, and informed consent forms. But are all the personnel credentials and certificates current? Have you checked that all lab certificates, reference ranges, and lab director credentials are on file – including all labs listed on the FDA 1572 form, if applicable? If the study is a clinical trial, have you referenced ICH GCP essential documents to ensure you have all recommended documents filed? In the final installment of BRANY QA’s post focusing on common findings in Quality Assurance Review, the QA team developed a regulatory checklist and study personnel worksheet you can use to review the study’s regulatory documents to check if your records to be up-to-date and audit ready. To download the checklist, worksheet, and other tools developed to aid in compliance checks, please visit https://www.brany.com/research-auditing-and-monitoring/.
Any questions? Please reach out to QA@brany.com.
Now let’s ask again – is your study’s regulatory binder up-to-date and audit ready?
