GCP Audit Checklist For Clinical Research

After an inspection, any significant findings will be forwarded to the GCP Inspection Action Group who will decide upon non-routine post inspection actions.

This GCP Audit Checklist for Clinical Research Sites in Vietnam has been designed to assess their capacity to conduct trials that comply with international medical and scientific standards. It focuses on determining whether clinical research sites have effective governance and operational processes, suitable infrastructures and sufficient qualified human resources.

1. Pre-Assessment
Step one in preparing for a GCP inspection involves identifying data flow. This requires identifying all entities responsible for handling trial data such as CROs, clinical laboratories and site management organisations (SMO). Each of these should be assessed for quality control procedures corresponding to each stage of data handling.

The MHRA also recommends that sites establish processes to reduce potential risks to human subjects by equipping staff with training, knowledge and skills necessary to identify serious violations of GCP or trial protocol and report these promptly to MHRA.

With this information in hand, the Principal Inspector and study team can develop strategies for responding to non-routine findings from inspections; such as quarterly reporting, early re-inspection or referral to relevant stakeholders.

2. Preparation
At a time when outsourcing is becoming an increasingly common part of clinical research, sponsors must devise strategies to ensure vendors comply with regulations such as those issued by ICH. This can prove challenging.

Preparing for a GCP inspection begins by understanding the flow of data entering and leaving your site. Every vendor that touches that data should be considered, from statistical service providers, CROs, or SMOs. Also important to keep in mind is an unannounced FDA inspection; having procedures and audit plans ready will help ensure your clinical trial can withstand such an inspection.

3. Monitoring
Sponsors often struggle to create an effective plan for tracking GCP compliance among vendors, whether that is CROs, clinical labs or SMOs. Every vendor needs to be evaluated on whether they implement quality controls with written procedures at every step in data handling processes.

Our research team has created and successfully pilot-tested a checklist for assessing institutional capability to conduct clinical trials. With 30 criteria covering governance, operations, infrastructures and human resources – covering governance certificates as well as certification of clinical research coordination units or CTMS software availability – our study evaluated whether all the mechanisms essential to running trials according to international GCP standards were present and functioning correctly. However, this study does have limitations that need addressing in future versions; specifically around certification issues as well as operational matters (certificates).

4. Reporting
Sites should have in place an established process for reporting violations of GCP or protocol and developing feasibility assessments, document recruitment processes and identify staff training needs.

Monitoring is crucial to ensure a trial runs in accordance with both its protocol and Good Clinical Practice guidelines, along with any applicable regulations. Investigators or institutions must agree to comply with GCP standards and allow monitoring, auditing and inspection by sponsor or regulatory authorities as part of this step.

Finalizing a clinical trial’s data involves creating a plan to identify, audit and manage vendors that could have an effect on its data, such as CROs, clinical labs or SMOs. Implementing such an oversight system may prove challenging but sponsors should ensure they take all implications into consideration before signing contracts with vendors.

5. Follow-Up
Sponsors should monitor vendor performance closely during this phase, including GCP compliance and data consistency and quality. Sponsors may use strategies to ensure vendors collect consistent, high-quality data for storage purposes.

MHRA inspections typically involve GCP system reviews that assess your organization’s processes for conducting clinical trial research. Under its risk-based approach to GCP inspections, you may also be selected for an individual trial inspection.

In such instances, MHRA inspectors will focus their inspection on how you manage trials. A lead inspector will liaise with you to arrange the unannounced inspection visit; once finished, their report will be sent directly to you via email; depending on their findings they could even refer it back to cross agency group for review; which could lead to CAPA recommendations being put forth as a result of their inspection results.