Typically, quality of a clinical trial is assessed by audits. Quality related audit in clinical trials, as in many other fields is a retrospective exercise. However, to ensure, consistent quality in clinical trials, it is important to make the quality assurance team an integral part of the whole process, from design to submission of reports. Instituting a regular internal and external auditor schedule the process, would not only help the sponsors and CROs to avoid unpleasant surprises later, but will enable them to detect and bridge gaps very early in the process.
Audits, however alone cannot magically transform an inadequately planned, executed, monitored, and or analysed trial into a credible one. Used effectively, though, external audits can reduce costs, maintain project schedules, and ensure regulatory compliance.
What needs to be audited
Regulatory documents such as the study protocol, institutional review board (IRB) communications, approvals, informed consent documentation, investigator agreements, curricula vitae, clinical laboratory accreditations and normal values (if necessary), randomization documentation, and records to determine whether the documents conform to sponsor requirements. Auditors compare the data in the source documentation--most commonly, the medical record--against data entered on the case report form (CRF). Because of the vast amount of material involved, this comparison must often be limited to just a sample of patients and selected data fields. Auditors should review trial related documents & SOPs applicable as per company & regulatory norms to ensure protocol compliance, addressing sample evaluation and reporting safety concerns.
Why external auditors
Independent audit of a clinical trial can bring a fresh perspective and new insights into the project. For example, the longstanding relationship between a clinical research associate (CRA) and the investigative site that he or she oversees can be a potential source of bias. A CRA typically visits a study site at regular intervals to make sure that procedures are being followed. An external auditor, who does not have such ongoing contact with a site, can be more effective in identifying lacunae and calling for any needed changes.
The key is to have an auditing plan in place, with the timings for the audits and the agency which will handle the audit, established for every single study.
Selecting an auditing agency
One of the first, and most important, decisions the company faces is choosing an auditor. Independent and external agency is the preferred choice when it comes to selecting auditing companies. As they are not associated with either the sponsor or the CRO or any other interested party, Independent Audit agencies can offer unmatched objectivity and insight in the auditing process.
Complementing the technical qualifications, the auditor must have an aptitude for details and logical thinking. A skilled and experienced auditor is able to pick up a minor inconsistency, deduce possible reasons, and then investigates, uncovering significant underlying issues. An auditor should have the patience to search for details and follow these leads, often under tight deadlines.
When used effectively, independent external audits can provide valuable insights into the quality of clinical trials. These insights and findings can then be used to fix the gaps but also those to create a robust system to avoid the costly mistakes in the future.
(The author is founder-director of clinical trials auditing services firm Vaatsalya)