Built by sites, validated by industry: the next chapter of the Digital Innovation Initiative begins this week.
The Society for Clinical Research Sites (SCRS), the premier global advocacy organization for the clinical research site community, today announced the AI guidance framework working group, the next chapter of its Digital Innovation Initiative (DII). The group will work to create the framework that will give sites a practical, independent foundation for adopting artificial intelligence safely and effectively, and give sponsors and CROs a credible benchmark for what good looks like at the site level.
AI is already reshaping site operations, from patient identification and documentation to data entry and communication. Yet sites have had no independent, site-specific guidance to inform their adoption decisions. The result is a lot of noise and very little clarity. This framework is designed to close that gap.
A working group of 12–15 site professionals will build the framework from operational reality, drawing on the day-to-day experience of the people who run trials. Members represent a range of roles and organization sizes, with adjacent AI practitioners contributing additional perspectives. The working group begins its work this week.
The process is designed to reflect the wider community, not only the working group:
Community survey – In November, SCRS will invite sites across our community to share how they are using, evaluating, or avoiding AI today.
Practitioner input – Case examples from practitioners already applying AI in site settings will ground the guidance in practice.
Industry review –In spring 2027, sponsor and CRO partners will review the completed draft to stress-test and validate it, without co-authoring it. The framework stays site-built and gains industry confidence.
“Sites are being asked to make AI decisions now, often without a trusted reference point,” said Jimmy Bechtel, Chief Site Success Officer at SCRS. “This framework starts with the people doing the work. Sites define what safe and effective looks like in practice, and industry helps pressure-test it. The goal is clarity the whole field can move forward on together.”
For sponsors and CROs, a shared, site-grounded standard supports more consistent expectations, smoother collaboration, and stronger trial execution. For sites, it offers a way to evaluate AI with confidence, on their own terms.
The completed framework will provide practical guidance on the safe and effective use of AI in clinical research site operations. It will be published as a living resource on the SCRS website so it can evolve alongside technology and the regulatory landscape. SCRS guidance is intended to support decision-making and does not constitute regulatory or legal advice, vendor endorsement, or certification.
About the Society for Clinical Research Sites (SCRS)
The Society for Clinical Research Sites (SCRS) is the leading advocacy organization dedicated to unifying the voice of the global clinical research site community. Representing more than 12,000 research sites globally, SCRS facilitates industry collaborations and conversations dedicated to site-focused advocacy, education, mentorship, and connection. SCRS is an active and influential champion for sites in industry initiatives to ensure that the perspective of sites is heard and valued. Our Voice. Our Community. Your Success. Learn more at myscrs.org.
