What is the SASI Standard for quality management?
It is an international standard specifically created as the foundation for a clinical research site Quality Management System. The Standard is based on Good Clinical Practice and conforms to international standards for quality management. If you would like a copy of it, please click here.
What is a Quality Management System (QMS) and how do they work?
An organization's single formal system for:
Planning, executing, assessing, improving quality
Methodology for proactively managing processes with clear process owners
A comprehensive approach that leverages industry experience and wisdom (like a sophisticated organizational checklist)
Systems and Methods used by organizations worldwide
Reduces waste, lower defects and errors, increases customer satisfaction, improves operational efficiency, and results in a more engaged workforce
How was the SASI Standard created?
In 2011, a group of experts in the field of clinical trials began working with the British Standards Institute to create the SASI Standard. In 2018, they successfully completed the first draft of the Standard, and their accomplishment was announced in the New England Journal of Medicine.
Who is the SASI Standard for?
The SASI Standard was designed to benefit all human clinical trial sites:
Phases 1 to 4
Studies with outpatient visits
Inpatient care with overnight stays
How would a Clinical Research Site benefit from using the SASI Quality Management System?
Minimize the costs associated with poor quality (rework, harm, failed studies)
Reduce reputational risk by ensuring that all parts of an organization adhere to the same quality standards
Engage and retain the best staff by prioritizing a quality culture (rather than a compliance culture)
Sponsors learn to trust that sites are consistently applying all of the practices required for producing reliable data
Secure more studies as sponsors use accreditation to identify sites
How do staff respond to working with a Quality Management System such as the SASI Standard?
Some might think that staff would not like working within a Quality Management System since they might feel overwhelmed by the requirements. In fact, the opposite has been found to be the case. Most staff appreciate the clarity for what they need to do. It allows staff to focus on their tasks and innovate within their area of responsibility. It is true that some staff don't adapt to working within a quality culture, but they are the minority. If these few individuals end up leaving the organization, the people responsible for overall quality are usually not disappointed.
What are the benefits to senior leaders in organizations with clinical research sites?
Senior organizational leadership can focus their attention on other strategic issues. SASI sets a clear definition for what is expected throughout organizations. Poor quality is more quickly recognized and addressed. In effect, sites within large systems learn to better manage their own quality.
Can sites use the SASI Standard without becoming accredited?
Absolutely! The only thing a site must never do on their own is claim to be accredited by SASI when they are not.
What training does SASI provide to organizations?
SASI provides supporting quality management training for leaders along with the Clinical Research Quality Manager (CRQM) Certification as part of its Exploratory Program. It is required for Accreditation and is provided by our partner the Quality Management Institute.
Does SASI provide Consulting services?
No, SASI does not provide consulting services. Our surveyors will assess sites for conformance with the standard, but they can't advise sites on how best to meet those standards.
What is the advantage of getting accredited by SASI?
There are two main reasons why sites become accredited by SASI:
Sites will discover non-conformances to the Standard that they might not otherwise recognize.
Sites will obtain the public recognition that SASI accreditation provides
What is the accreditation process?
On-line training by QMI
SASIware quality management application for documentation and improvement
Teleconference to review and confirm conformance with SASI Surveyors
Site visit for verification and validation
Which organizations are currently seeking accreditation?
SASI respects confidentiality and only publicly reveals the name of sites after they have completed all of the requirements for accreditation.
How should a Clinical Research Site get started?
How long does the SASI Accreditation last?
A clinical research site is granted SASI Accreditation for a period of three years.
What is the cost of Accreditation?
The best way to get started working toward accreditation is with the SASI Exploratory Program, which costs $4,944 per site. After that, the work required to complete accreditation varies significantly between organizations, so we are reluctant to quote a standard price for accreditation without first having a conversation to assess your organization’s needs. If you wish to arrange such a conversation, please contact us, and we would be happy to provide an estimate.
Anything else we can answer?
If you still have questions, please feel free to contact us, and we will be happy to answer all of your questions.