The GCSA Certification Journey
It highlights where a site is already excelling, and identifies any areas for development across the 7 high-impact business operational areas, cited by sponsors/CROs as being critical to the delivery of world-class clinical trials.
The 7 GCSA Pillars:
Patient Engagement
Feasilibity
Study Start up & Initiation
Study Management, Operations, & Close Down
Workforce Process Quality
Business Strategy
Governance
Sites embarking on the GCSA Assessment Process will go through the following Journey
Launch
Document Request
Launch to Workforce
Assess
Document Review
Staff Surveys & Discussions
Report
Gap Analysis Report (detailing areas of excellence and areas for further consideration)
Improvement Time
Feedback provided to site and time agreed to allow site to make improvements (if needed)
Reassessment conducted
(only if improvements
are needed)
Award
Marketing
Post-certification marketing support provided by GCSA Team
Frequently Asked Questions
How long does the assessment and certification process take?
How do we provide the documentary evidence?
The GCSA Assessment Team will provide clear guidelines and support regarding the necessary documents you will need to provide to allow assessment and gap analysis across the 7 assessment modules. Documents are normally uploaded into a secure shared portal.
How much staff time/investment is required to complete the process?
The GCSA certification journey engages the whole clinical research team in a positive, inclusive and supportive way. In addition to gathering the necessary documentary evidence, staff are involved as follows:
- 1 hour kick-off meeting – A motivating launch meeting to engage your workforce and answer their questions (conducted virtually, or in person upon request)
- 30 minute online survey – Sent directly to your workforce. We encourage as many people to complete the survey as possible, it provides an opportunity for everyone to share feedback and ideas.
- 30 minute 1-to-1 discussions – Held with a selected sub-group of your workforce, enabling GCSA assessor to gain a deeper understanding
- Award ceremony and staff celebration – This can be as short or long as you wish. Most sites take the opportunity to gather their team together to celebrate the success (we will continue to work with you to help market and publicize your success to the industry)
What is included in the report?
The Gap analysis report is highly detailed and comprehensive. It clearly highlights where a site is excelling, and where there are areas for further consideration or development. If development areas are identified, recommendations are clearly stated.
