KEY HIGHLIGHTS
- FSS auditors have been carrying out Trial Master File (TMF) audits for NHS Scotland since 2007
- Our audit work ensures they meet their Research Governance Framework audit goals, as well as contributing to a quality research culture and promoting good practice
- FSS audits have led to improvements in hospital research site practices, and the readiness of those sites and NHS Scotland R&D offices for UK regulatory inspection
- We have helped health boards comply with international Good Clinical Practice standards and in a key case, supported one board to develop their own internal audit system.
THE BACKGROUND
NHS Scotland Health Boards are required to independently review research projects run by their hospitals and GP surgeries. Auditing supports a robust study monitoring strategy, strengthens quality research culture and promotes good practice. These research projects subject to audit could be a Clinical Trial of Investigational Medicinal Product (CTIMP), a device study or a student academic project. FSS has provided these auditing services to NHS Scotland since 2007.
When a project is selected for audit, the researcher has to make specific documentation available for review (called the Investigator Site File), plus R&D files. Our auditors start by reviewing the R&D documents for awareness of governance, ethics, regulatory approvals and Integrated Research Application System (IRAS) information, and then compare this against a review of the contents of the Investigator Site File. All documents are checked against Good Clinical Practice, applicable UK trial and data protection regulatory requirements and sponsor TMF requirements. Research staff may be interviewed for familiarity with protocol, study procedures, data protection and site obligations.
Any site observations by the auditors are discussed at the exit review meeting with the researcher(s). Post audit, a written report is issued to the R&D department, which distributes project-specific observations to key study research personnel.
THE CHALLENGES
Carrying out site audits can present many challenges. Our auditors are tasked with delivering a critical review of the studies in question, and we set a high bar, so they often will highlight non-compliances and inconsistencies to people who are passionate about the research project
Researchers can also have a mixed awareness of and interest in documentary compliance requirements. Their time is often very restricted, and they have to focus on their primary responsibility of patient care, so understandably, their engagement with audits can be limited.
To carry out an audit successfully, we rely on complete TMFs to be able to reconstruct the trial activities and carry out a careful evaluation. Incomplete, inaccurate or missing documents, research processes or indeed entire mislaid TMFs make it difficult to reconstruct events.
Finally, there is a wide-ranging set of research areas to review. We review multiple research projects – up to three – during a single NHS audit. We also cover dozens of topics, including (but not limited to): contracts and legal agreements, financial aspects, trial team qualification, , ethics and regulatory notifications and approvals, protocols, informed consent, safety reporting. We can carry out facility checks on labs and pharmacies as needed too
OUR SOLUTION
To achieve the best audit outcome, we remain approachable and considerate of researchers’ limited time. Our auditors are technically skilled, and they are also effective communicators who build collaborative and longstanding relationships. Our team is ever mindful that study participants’ rights, safety and wellbeing are the primary consideration in any research study.
We share our industry CTIMP knowledge and good documentation practices, providing recommendations for improvement alongside advice on setting realistic action plans and goals. Our audit reports include an explanation of risk and the impact of non-conformances to support the NHS with continuous improvement and give NHS research departments the ability to initiate their own internal audit programme.
THE OUTCOME
Our audit work for NHS Scotland ensures it meets its Research Governance Framework audit goals, contributes to a quality research culture and promotes good practice
Over the years, we’ve helped NHS Scotland improve:
- the study practices of its hospital research sites
- compliance awareness
- the collection of evidence to make research study evaluation easier
- the readiness of its R&D offices for UK regulatory inspection.
We have also helped several health boards comply with international Good Clinical Practice standards. In a key case, we worked with a health board to help them develop their own audit system. With a better understanding and the relevant processes in place, they now undertake their own internal research project auditing programme.
Our experience with NHS Scotland has been a growth process for FSS, too. Over the last 15+ years, we have reviewed, improved and evolved our own practice and services. Now, as well as offering a TMF auditing service, we also provide a bespoke auditing system consultancy service supported by a team of trained staff with a range of auditing skills and practical experience.
If you would like to learn more about how Frontier Science Scotland can support you with research audits – or any of our other services – please get in touch.
