Adhering to regulations and requirements are necessary components for the ethical conduct of clinical research, and FDA audits are an integral part of the process. Audits may be announced or unannounced. In either case, they can trigger extreme concern for site staff. “The prospect of an unannounced FDA inspection can loom over a clinical trial site. While the vast majority of inspections are pre-scheduled, FDA is more likely to arrive without warning if the inspections was assigned as a result of information that raises concern about the site…”https://acrpnet.org/2017/08/30/fda-offers-tips-triggers-inspections/ There are a number of reasons that clinical research sites are audited and there are several approaches that can assist clinical research sites to be audit-ready.
Grounds for an FDA audit include:
- Sponsor concern
- Complaint to the FDA about the conduct of the study
- Termination of a clinical site
- To assess a PIs (Principal Investigator) conduct of the trial and the protection of human subjects
- A request from the FDA review division
- Targeted inspections related to certain classes of investigational products deemed as special interest
What happens during an FDA audit? The audit is scheduled between the FDA and respective site. Upon arrival, the inspector should present Form 482 (Notice of Inspection) to the site staff. This document shows the inspector has authority to inspect the facility and affiliated documentation. If this document is not produced, the site coordinator should ask for it before the inspection begins. Some internal site paperwork, is however, not included for review. “An inspector can ask for the manufacturing records of the regulated product and can enter the area where the product is being manufactured. He can review online records, collect samples and interview the personnel working in the area. An inspector can’t review the product price list, financial data of the firm, product marketing data, research documents and employee data excluding the training records. These documents are considered as the firm’s confidential documents.” https://www.pharmaguideline.com/2014/11/fda-forms-issued-in-inspections.html
After a tour of the facility and discussions with staff, and appropriate records are reviewed, error confirmations and error notations are recorded. The inspector provides the list of the observations that have been made via Form 483, generally to the site’s management, (who originally received the Notice of Inspection).
Approaches for being audit ready:
- Verify the date the auditor is coming and schedule a meeting prior to their visit to review all items that are listed on the auditor’s agenda.
- Understand the purpose of the audit.
- Provide the auditor with a list of key contacts.
- Identify the staff the auditor will need to speak with and do a trial run.
- Ensure all training records are accurate and maintained in an organized manner.
- Verify that employees have been trained according to the training plan.
- Review work instructions to ensure they’ve been implemented effectively.
- Update organizational charts.
- Review SOPs and employee manuals to confirm they have been updated in the last 12 months.
- Establish that records are easily accessible for the auditor (hard copies are preferred so the auditor does not have to access computer files).
- Update all SOP revision histories.
- Confirm that trackers are accurate and up to date.
- Determine that all periodic reviews have been completed and documentation is updated.
- Ensure computer security is in place for all staff (username and password) and computers are secured when employees are not at their desks.
- Confirm that findings from previous audits have been addressed and corrected, if applicable.
- Have previous audit reports available for review, if requested.
- Decide who will participate in the opening meeting with the auditor and formulate questions in advance.
- Be professional, cordial and cooperative, at all times. Do not be defensive or argumentative.
- Provide a quiet, private place for the auditor to review files and documents. This can also serve as an interview space where questions can be asked and answered.
- Remove obsolete documents.
- Document cases that needed corrective action and review any non-conformance issues.
Properly preparing for audits increases the likelihood they will be executed with precision. Healthcare organizations conducting research work continuously to identify opportunities to improve efficiency, increase profitability and advance growth. Learn how GuideStar Research industry leaders can assist your clinical research program.
Post by Melissa Daley -
Melissa develops social media and digital marketing content strategies and produces a variety of collateral with creative, effective messaging. Melissa has served as an educator in higher education for close to two decades.