This article has been updated since it's original publication date.
Good clinical practice (GCP) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human subjects. Investigators, sponsors, clinical research organizations (CROs), and institutional review boards (IRBs) must have a working knowledge of GCPs for assurance of the best protection of human subjects and the preservation of the quality, reliability, and integrity of the data. Learn about GCP audits below, or contact our experts for additional guidance.
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The GCP audit serves as a critical interface to ensure compliance. It assesses whether the principal investigator and site support personnel adhere to regulatory requirements outlined in the clinical trial protocol and the clinical quality management plan (CQMP). The CQMP is an extension of a sponsor or CRO’s quality programs and standard operation procedures.
During the site feasibility and qualification process, the sponsor or CRO personnel will not only verify professional credentials but also evaluate the site's capacity and available resources to fulfill their assigned duties both professionally and administratively. Non-compliance can lead to failures, delays, unrecognized adverse events, and most importantly, compromise the integrity of the trial data and protocol. This could lead to a challenge of the clinical trial results by regulatory authorities.
GCP audits serve various purposes relative to the clinical trial process. It is not always a site(s) and monitoring audit—a GCP audit can be a full clinical trial audit over systems and operations conducted by monitors and trial management, a full clinical trial audit over the clinical trial sites, or an audit of the CRO carrying out the clinical trial on behalf of the sponsor. Additionally, GCP audits can also be conducted for CRO qualification and selection.
GCP Audit scope can encompass various aspects, including:
- Auditing data management and electronic data capture (EDC) systems
- Electronic medical records (EMR) integrity
- Interactive response technology (IRT) systems such as IVRS and IWRS
- Regulatory compliance for essential document collection and integrity throughout the study
- Institutional review boards/international ethics committees
- Specialized Phase 1 unit compliance
- Phase 1 SOP development and training
- Third party vendors
Experienced auditors will help identify potential risks and help to ensure that the compliance issues do not jeopardize the study. It is crucial that the clinical trial auditor has a solid understanding of the clinical trial process and objectives. Sites seeking participation in a trial are particularly interested in the site qualification process and compliance expectations before, during, and after the clinical trial. Transparency regarding site responsibilities within the CQMP is also essential.
Once selected, the site wants a clear and thorough study start-up process and an explanation of the potential for an audit by the sponsor or regulatory authority. That means that each member of the site team has obligations to fulfill with regards to the CQMP and GCP compliance.
CQMP requires each site to have a quality management coordinator. This coordinator works closely with the principal investigator and the clinical study coordinator (CSC). The purpose of the CQMP is to identify and document the ongoing processes and activities that are used to monitor and facilitate quality protocol execution, including data collection and entry following study initiation. A good compliance organization can support the development of this CQMP for discussion during the clinical trial kick-off and initial investigator meeting.
The site CSC is responsible for ensuring all study personnel have completed all required institution-specific and protocol-specific trainings and that these trainings are documented appropriately in the training log. The site will maintain a delegation of responsibilities log. The CSC will verify that all training is current and appropriately documented on a quarterly basis.
Finally, the quality management coordinator ensures, on a quarterly basis, that a report is filed internally as a reference for the CRO clinical research associate and other external clinical trial responsible parties.
This report will include assurance of:
- Integration of new personnel
- Consent process completion
- Source document completion and review
- eCRF review to minimize correction of induced data entry errors
- Assurance of ongoing equipment calibration and maintenance
- Proper handling of investigative product and logs
- Awareness of any protocol or study changes based on shared data with other investigators
The report will also document other matters related to important events such as SAEs and AEs and note any corrective actions undertaken by the site independently or at the request of the CRA from the sponsor or CRO.
These site responsibilities are vital to the clinical trial process. A comprehensive GCP audit will include a review of the information found in the CSC report, which is crucial to the audit process and contributes to a n efficient and streamlined site audit.
However, since the CSC requirement is not well understood by most sites and principal investigators, we will address this in a future blog.
A meaningful GCP audit of a clinical trial will focus on the integrity of this process and the compliance of the site with all aspects of the protocol and the actions of each person who handles some aspect of the clinical trial. With the 21st Century Cures Act calling for more patient-centric analysis and real world experience during and after the clinical trial, it behooves clinical trial sites to understand the necessary quality standards compliance and to be organized and prepared for the GCP audit that is sure to come.
Are you and your administrators ready to address these ongoing compliance aspects of the clinical trial process? Be an attractive site to work with. A little diligence to be ready will put you at the top.
