Preparing for a Site Audit

¶ … Audits

There are several different types of audits: sponsor, IRB and FDA. A sponsor audit is one where the company sponsoring the trial pays for and organizes the audit. An FDA audit is conducted by the FDA, and an IRB audit is an institutional review board. An IRB audit is therefore an audit conducted by the institution (university or hospital, most commonly) whose personnel and facilities are being used to perform the audit.

These audits are differentiated mainly by the body that is conducting the audit. Each body will conduct the audit based on its own interests. For example, FDA audits are conducted to ensure that the work on the trial is being conducted according to the regulations. IRB and sponsor audits will be conducted to varying specifications that reflect the interests of those bodies, so they will be more variable in nature. That said, they will not be entirely variable -- many aspects of audits are common to all audits, in particular where adherence to FDA regulations are concerned.

There are several different steps with respect to preparing for an audit. The first thing is to always be prepared for an audit -- if the site does everything by the book and is in a position to be audited at any time, then it will be able to manage an audit much better than if it has to rush around getting its house in order.

The first step once an audit is announced is to get information about the audit, in particular with respect to its time and its scope. Different agencies publish guides that help sites to prepare for audits. A checklist should be available prior to the audit that outlines what the auditor is looking for, and this should always be obtained as soon as possible (ICTR, 2013). Audits are heavy on checking for records and documentation, so the site manager will need to ensure that all documentation is available, that it has been properly catalogued and that it is ready to be presented to the auditors. The site manager will need to ensure that all protocols with respect to drug handling are being followed, and if there are any gaps within the facility that those are dealt with immediately.

The site manager will then need to ensure that the audit is communicated to the rest of the staff. The staff will all need to know several things about the audit, and there may be some training that is involved. The staff will first need to know the details of the audit. This includes some specific training about the audit checklist, so that everybody understands exactly what the auditors are going to look for. The staff will also need to know basics about handling audits, especially if they have never experienced an audit before. Further, if there are any material differences between the present audit and prior audits, those should also be outlined for the staff, so that they are aware of such differences.