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Clinical research excellence

The prestigious Global Quality Standard for Clinical Research Sites (GCSA) was awarded to the Grounded Research team in January 2025. This certification marks a significant achievement that positions Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH) as a leader in the field of clinical research. The certification journey follows a rigorous, independent assessment against GCSA’s globally recognised quality standards, affirming the trusts’ commitment to delivering the highest level of clinical trial excellence.

The GCSA certification is the world’s only internationally recognised quality standard and certification for clinical trial sites. It recognises organisations that have demonstrated excellence across the critical business operational areas that underpin the delivery of world-class patient and sponsor experiences across the end-to-end clinical trials pathway. By meeting the specific criteria across seven key areas, ranging from feasibility and study start-up to patient engagement and governance, the Grounded Research team at the trust has demonstrated its ability to provide the highest quality and efficiency in clinical research.

Heather Rice, Director of Research and Innovation, Grounded Research at the trust explains:

“Demonstrating adherence and commitment to global best practice is essential for NHS research teams. It offers confidence and assurance for patients and provides an independent benchmark to our communities around the research we undertake,”

“By proving that we are operating to the highest of quality standards, it provides our clients evidence that we are a trusted and valuable partner for the delivery of clinical research. Furthermore, our workforce is strengthened by attracting, engaging with, and retaining staff who work at the highest possible standards.”

The trust’s certification is a testament to its clinical research infrastructure, operational excellence, and the dedication of its workforce. The trust’s achievement of GCSA certification demonstrates the standards it continues to strive and follows their success of becoming the first NHS trust to achieve the gold standard Workforce Process Quality Certification (WPQC) for Clinical Research Sites in April 2023, awarded by the International Accrediting Organisation for Clinical Research (IAOCR).

Sarah Everitt, Vice President of Operations, International Accrediting Organisation for Clinical Research (IAOCR) and GCSA explains:

“By achieving this certification, RDaSH has shown it not only meets but exceeds global standards in clinical research site management”

“The trust’s successful certification also positions it to play a pivotal role in advancing clinical trials and improving access to cutting-edge treatments for patients in the region. This milestone builds on RDaSH’s earlier success in achieving the IAOCR Workforce Process Quality Certification and further demonstrates the outstanding dedication and skill of their research team.”

The IAOCR and GCSA certification processes are based on comprehensive assessment frameworks which have been developed with and ratified by global industry experts and opinion leaders. The GCSA Quality Standard for Clinical Research Sites was developed by IAOCR in close consultation with a global advisory board of key stakeholders and leaders from across the industry and assesses the following seven core business operational areas identified by sponsors and contract research organisations as being critical to the delivery of high-quality clinical trials:

  • governance
  • site business strategy
  • workforce quality
  • patient engagement
  • feasibility
  • study start-up and Initiation
  • study management, operations and close down

Complimenting the Global Quality Standard for Clinical Research Sites (GCSA) certification, the WPQC provides a clear benchmark of the highest workforce process standards for both those working within the organisation to pride themselves on, and for sponsor’s and contract research organisations looking for a “trusted global clinical research partner” with demonstrable evidence of quality workforce standards.

Whilst clinical research is a highly regulated industry, until now there have been no established standards by which sites can demonstrate that they are able to meet the expectations of sponsors, contract research organisations and patients, and no way for sponsors or contract research organisations to select clinical research sites based on clear quality standards which have been independently assessed at the organisational level.

GCSA sets this much-needed industry standard for research sites to strive for and achieve; it allows sites to evidence and communicate their capabilities and differentiate in a crowded and increasingly competitive marketplace. Beyond the assessment and certification process, where required, GCSA will deliver individual, practical support on the areas for development to meet the standards and will work collaboratively with sites to achieve certification.

Becoming an award winning site

In the video below we talk about becoming the first NHS trust to achieve the gold standard Workforce Process Quality Certification (WPQC) for clinical research sites in April 2023.

Page last reviewed: August 20, 2025
Next review due: August 20, 2026