Site-Sponsor Consortium Releases Practical Recommendations and Tools to Reduce Duplication, Ease Site Burden, and Support Audit-Ready Trial Execution
Columbia, Md. – Oct. 27, 2026 — The Advarra-facilitated Site Sponsor Consortium today released a new framework and 11 practical tools designed to help sponsors and CROs reduce repetitive clinical trial site training while maintaining quality, compliance, and inspection readiness.
An analysis of 16 recent Site Initiation Visit (SIV) training presentation decks from industry-sponsored Phase II and III studies informed the Consortium’s recommendations. The analysis found that SIV training presentation decks ranged from 75 to 381 slides per trial and, on average, more than half of the content in each presentation—approximately 61%—was not specific to the study being initiated.
The Consortium’s members—senior leaders from global biopharmaceutical companies, CROs, and research sites including healthcare systems, cancer centers, and site networks—developed the framework to reduce this duplication without weakening sponsors and CROs’ ability to demonstrate that site personnel are adequately trained on the protocol. The framework establishes criteria for determining when prior training and competency records can be accepted, when additional study-specific training is required, and how those decisions should be documented to support audit and inspection readiness. In addition, the framework includes tools for testing the approach through controlled pilots before broader adoption.
“Training is fundamental to protecting research participants and ensuring studies are conducted ethically and successfully, but the way it is delivered has not kept pace with the growing complexity of clinical trials or with the principles of how humans learn,” said Christine Senn, SVP of site-sponsor innovation at Advarra. “As experienced site teams work across multiple studies, sponsors, CROs, and technology platforms, we have an opportunity to recognize what they already know and focus their time and attention on the information that matters most for each study. We can—and should—strive to make training more effective, not repetitive.” For site coordinators, the framework could mean recognition of relevant prior training, with any additional training focused on the protocol, role-specific responsibilities, critical risks, and remaining gaps.
To evaluate the impact of more focused training in real-world studies, the Consortium developed two companion papers outlining suggested pilots: redesigning SIV training and recognizing prior electronic data capture (EDC) platform training. Eleven supporting tools and templates provide sponsors and CROs with resources for planning, implementing, documenting, and evaluating the pilots.
“Site teams take training seriously, but when a presentation stretches to 50, 70, or more slides—and much of it covers material staff have already been trained on, sometimes repeatedly—it becomes harder for the most important study-specific information to stand out,” said Kyle Bird, VP of clinical research, Harvard Cancer Consortium. “A more focused approach would give protocol-specific risks, responsibilities, and operational requirements the emphasis they deserve, helping teams stay engaged and better prepared to execute the study.”
Data released by the Society for Clinical Research Sites (SCRS) last year identified EDC system training as the leading source of training redundancy, with 67% of respondents identifying EDC as the top redundancy source[1]. The Consortium’s EDC Toolkit offers guidance on ways for sponsors and CROs to work with their vendors to decrease these redundancies.
“Sponsors and CROs have a responsibility to reduce the burden we place on sites,” said Ian Wyglendowski, head strategic clinical partnering, UCB Biosciences. “When current documentation provides sufficient evidence of competency, we should not automatically require teams to repeat training. A more targeted approach can preserve quality, allow site teams to focus on participant care and trial execution, and make us better partners.”
The Consortium encourages sponsors and CROs to pilot the framework with one or two studies, with the goal of reducing repetitive training and giving site teams more time to focus on the protocol, critical risks, and effective study execution.
The framework, suggested pilots, and supporting tools are available on Advarra’s website.
About the Advarra Site Sponsor Consortium
The Advarra Site Sponsor Consortium brings together senior leaders from sponsors, CROs, academic medical centers, cancer centers, healthcare institutions, and independent research sites to identify critical challenges and co-create practical, scalable solutions for clinical research. Organized by Advarra, the Consortium’s work is non-promotional and focuses on industry-wide advancement.
About Advarra
Advarra provides the platform, insights, and expertise that make clinical trials more efficient and connected. As the leading independent IRB, we bring more than 40 years of trusted oversight to the industry, setting the standard for ethical reviews while building the largest collection of digitized protocols and operational data. This combined intelligence guides the protocol’s entire journey—from design through review, activation, and conduct—fueling a smarter, more adaptive research ecosystem.
Backed by decades of partnership with research sites, Advarra delivers the core systems and services that 50,000 investigators and their study teams depend on for optimal trial operations. Integrated with our solutions for study design, startup, and conduct, these capabilities create a collaborative technology platform trusted by sponsors and CROs globally.
By designing AI-powered workflows that streamline operations, reduce administrative burden, and promote transparency for all study stakeholders, we’re reimagining what’s possible in clinical research. Learn more at www.advarra.com.
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[1] Society for Clinical Research Sites (SCRS). Cut >25 in 2025: Strategic Guidance for Industry Partners: Data-Driven Playbook for Reducing Clinical Site Training Burden. 2026.