In any clinical trial, good clinical practice (GCP) must be consistently maintained. According to the Food & Drug Administration (FDA), GCP is “an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.”
Ultimately, GCP principals assure the data is accurate, reported results are credible and accurate, and the rights, integrity and confidentiality of trial subjects is protected. Ensuring your clinical site is following GCP at all times is imperative, ensures quality research is conducted and keeps a protocol on schedule.
Investigators and their study teams are responsible for the ongoing, operational aspects of conducting a clinical trial according to GCP. Clinical quality assurance (CQA) auditors are responsible for conducting GCP audits at a sampling of investigational sites. If a clinical trial is conducted at multiple centers, the CQA auditors will use a risk-based approach to select which investigational sites are audited. Conducting audits at multiple sites for a clinical trial allows the auditor to provide feedback on individual site issues and/or systemic issues which might impact multiple sites.
Parts of a GCP Audit at an Investigational Site
When an auditor conducts a GCP audit, there are generally three parts to the audit: interviews with site staff, documentation review and a facilities tour. This is done to ensure a research site is audited thoroughly and completely.
As part of a GCP audit, the auditor will determine if you are outsourcing any of your clinical trial work to third-party service providers and will assess your management and oversight to ensure those vendors adhere to the standards set forth by GCP. Ultimately, the principal investigator (PI) is responsible for the quality of the study and is inclusive of any outsourced work.
The auditor will also ask questions about any systems used as part of your clinical trial management. These may include electronic medical records (EMR), electronic data capture (EDC), electronic regulatory document management (eReg) and more. They will want to understand your processes and procedures, ensuring you have appropriate documentation for any validation of these systems, if necessary.
At the conclusion of the audit, the auditor will discuss with the appropriate representatives the outcome of the audit, including any findings or deviations from the study protocol or GCP requirements. This is a good time for the investigator and team to ask any questions and understand what needs improvement.
What a GCP Audit Accomplishes
The main goals of a GCP audit include:
- Ensuring the study is being conducted according to the protocol, local regulations and ICH-GCP R2 requirements
- Ensuring study participants’ rights are respected and secured
- Ensuring the integrity, completeness and protection of data collected throughout the trial
With these goals at the forefront of every research staff member’s mind, it ensures the rights, integrity and confidentiality of trial subjects are protected.
A GCP audit helps give research staff an idea of the quality of their research for a particular study, allowing staff to see if there are any measures needing correction before the results are impacted. By correcting potential roadblocks ahead of time, it will save the site time and money in the end. This will also enhance your site’s reputation as a place that produces reliable and credible results from their trials.
Adhering to GCP
Knowing what a GCP audit accomplishes is the first step; adhering to GCP from initiation of a trial through closure can be just as challenging. A study monitor or auditor will give your site the advice needed to make sure compliance is intact and the study is not jeopardized, but it is you and your staff’s responsibility to take the advice and apply it to the study. Using a study conduct checklist or working with a consulting service can help keep everything in line so your staff is not missing any important steps.
Not following compliance recommendations can lead to delays in a study, but more importantly: data integrity or a protocol could be altered. In order to produce quality research studies for your site, it is imperative to keep GCP at the forefront of operations, since a site’s success largely depends on it.
Advarra’s full-service GxP/GCP Auditing and Compliance Consulting team provides practical assessments and advice for any aspect of clinical study conduct. You can learn more about Advarra’s Consulting Service on their website.