Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What is a specific requirement for trial auditing as per ICH GCP E6?

1. Auditing must be conducted by the site staff

2. The sponsor must appoint independent individuals for auditing

3. Auditing reports should be routinely requested by regulatory authorities

4. All audit findings should be shared with the trial subjects

The correct answer is: The sponsor must appoint independent individuals for auditing

The requirement for trial auditing, as specified in ICH GCP E6, emphasizes that the sponsor must appoint independent individuals for the auditing process. This is crucial because independent auditors can provide an unbiased review of the trial's compliance with regulatory standards and good clinical practice. Their objectivity helps to ensure that the results of the audit are credible and that any issues identified can be addressed without potential conflicts of interest. Involving independent auditors fosters integrity in the trial data and assures regulatory authorities that the trial is being conducted ethically and in accordance with established guidelines. In contrast, having site staff conduct the audits can lead to conflicts of interest and may not yield a thorough or impartial review. Regulatory authorities typically do not request auditing reports routinely, as audits are more of an internal quality assurance measure rather than a compliance requirement. Moreover, sharing audit findings directly with trial subjects is not standard practice, as it could compromise confidentiality and data integrity. Therefore, the appointment of independent individuals for auditing is aligned with best practices in ensuring the credibility and integrity of clinical trials.