How was the GCSA standard developed?
GCSA was developed over a number of years in response to recommendations and issues raised by a broad range of industry stakeholders, including sponsors, CROs, NHS, NIHR, ABPI, HRA and other healthcare providers. The standard is endorsed by the GCSA Global Advisory Board (see About GCSA).
What are the key benefits of participating in the GCSA process?
The GCSA process provides numerous benefits for sites, staff, patients and sponsors (see About GCSA).
The assessment and gap analysis process enables sites to gain a thorough understanding of any R&D pathways problems and formulate an action plan to address them. The resulting certification marks provide a clear signal that your site is working to an industry-defined best practice standard that has been robustly and independently assessed. Overall, commitment to the GCSA journey signifies that your site cares about quality, is committed to best practice and wants to be a clinical trial partner of choice.
I'm setting up a new site. Can GCSA help?
The best way to reduce risk and build quality into your clinical trial processes is to ensure you’re working to best practice standards from day one. If you are setting up a new site or SMO please contact us as soon as possible – we can help you to embed GCSA as a foundation for success.
How much time does the process take?
Overall, the assessment phase takes between 1 – 4 weeks depending on the number of modules, the size of your workforce and the number therapeutic areas involved. The assessment process includes a kick-off workshop and interviews with a cross-section of your team. Each staff member involved can expect to dedicate about 1 – 2 hours of their time in total.
What is the duration of the assessment?
From the initial kick off workshop to the gap analysis report the process usually takes up to 14 weeks. This depends on the size of your workforce, the number of GCSA modules taken as well as the availability of your team members.
How is the assessment conducted?
GCSA has operated effectively throughout the pandemic. Our team is adept at working with site teams remotely and internationally and in most cases it isn’t necessary for us to meet in person.
Is the process confidential?
Yes, the entire process including the information and advice you receive from GCSA will be confidential to your site. Additionally all conversations with staff are confidential and no names are attributed to feedback in the report.
How many modules should we undertake?
Undertaking assessment in all seven modules at the same time is the most cost-effective approach and makes best use of staff time. However, many sites choose to start with just one or two modules. If requested, GCSA can guide you on which order to undertake modules to address any specific goals and challenges.
What happens if we don’t pass the assessment?
The GCSA process includes a comprehensive gap analysis report and feedback session. If you achieve the standard in some modules, but have gaps in others you will be awarded certification marks for the modules where you meet the standard. During the feedback session we will discuss any gaps identified as well as the way forward.
The feedback report provides a percentage score indicating to what extent you have met the standard. If your “met” score is 90% or higher there will be no fee for re-assessment providing the gaps are addressed within 3 months. If the “met” score is lower than 90% there may be a small fee for re-assessment.
Can GCSA support us with process improvement?
If gaps are identified during the assessment process you will need to address them before the relevant certification marks can be awarded. We can provide you with a quotation to use GCSA process improvement services, however there is no obligation to use us, you may wish to work on the the improvement plan yourselves or to select a third party provider of your choice.
Is there an annual re-assessment fee?
GCSA is a continuous quality assurance and improvement process. After you have achieved the standard we will maintain oversight and provide reassessment and feedback, taking a risk-based approach. No additional fees are payable during the first year following achievement of the standard. Following that average participation fees usually range between £500 – £2000 ($625 – $2,500) per quarter depending on the size and complexity of the site.
Can GCSA help to promote our site?
GCSA can design a joint marketing plan with you to help promote your site. Where possible we will also facilitate networking, best practice sharing and partnership development.
Who oversees the GCSA standard and ensures it stays relevant and current?
GCSA works with a Global Advisory Board (GAB) of volunteers comprised of key industry stakeholders (see About GCSA). We acknowledge that clinical trial processes and best practice standards need to evolve, sometimes rapidly, in response to evolving technologies, healthcare challenges and stakeholder requirements. The GAB meets regularly to review the standard, provide insights and recommendations and to agree actions on how to promote and support the GCSA standard.
How can we start our GCSA journey?
Being assessed and working towards an independent quality standard can feel a little daunting and sometimes sites ask us if they’re ready for assessment. GCSA works with sites at all stages of their process improvement and quality standard journey – it doesn’t matter if you’re big, small, established or just starting out.
Maybe you’re a high-performing site seeking independent recognition of your process quality or maybe you’re a site wanting best practice advice and assistance. Wherever you’re at in your journey we’re here to help!
GCSA is a collaborative and rewarding process. We provide constructive feedback and advice in a way that motivates your team to continue with the great things you currently do whilst making process improvements that are impactful and build capacity.
Each site is unique – contact us to discuss the best approach to achieve your goals.
A global quality standard for clinical trial sites developed with a Global Advisory Board of stakeholders from across the clinical research industry.
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