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Conducting Audits for Contract Research Organizations (CROs)

BayBiotech.NET
Performing site visits to your CROs for compliance audits at certain time intervals ensures the integrity and quality of data you are receiving for the clinical research. Sponsor audits also set stage for engaged CROs to prepare for direct FDA audits and leads to increased chances of success.
Audits may be either routine audits to check the facilities for compliance or may be based on the performance or any non-compliance issue that may have come in the highlight during the course of the study. In either case an audit provides CROs with timely opportunity to take corrective and preventive action measures and makes the CRO facility aware of sponsor’s vigilance leading to compliance on their part as well as best outcomes of financial investment for the sponsor.
Before performing an audit, an audit plan must be drafted by the auditor specifically preparing a check list of the items or issues that are recognized as critical steps of the procedures performed at CRO sites. This information might be gathered from the team members at sponsor’s organization who have been involved in developing the SOPs (Standard Operating Procedures) and standards for the studies conducted at the CRO site. It is the job of the auditor to ensure that the audit plan and the accompanying checklist have all the critical components included relevant to the quality performance.
After finalizing the plan and a checklist, auditor must have the higher management’s approval for the same before visiting the CRO site. Some of the important components to include in auditor’s checklist for a CRO visit are: checking for completeness of training records of the employees, making sure the current version of SOPs are in use, facility is 21CFR Part 11 compliant, ensuring that critical steps of the procedures are performed according to the protocol as well as the general health of the facility appears to be of standard quality as well as in accordance with different federal and state compliances. A successful auditor must also be able to understand the complete reporting structure and roles and responsibilities of the employees at the CRO site.
Once the audit is completed, auditor must present a report with important findings highlighting the non-compliance issues within a month’s time frame and communicate the findings to the higher management and consecutively to the CRO for corrective and preventive actions.

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