Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over Volume
By Ashlin Dunne, MSD; Anne Marie Inglis, GSK; and Ann Katrine Miranda, Novo Nordisk
A dermatologist logs into a required training portal and presses play. The video runs for 45 minutes and explains how to perform a punch biopsy, a procedure she has done routinely since medical school. She watches anyway, because that’s what participation in a clinical trial requires.
Down the hall, a study coordinator opens a different portal and begins another round of intensive training on a data capture system she has used across multiple studies. The screens are familiar, but she still has to complete the module before access is granted.
These are small moments, but they capture a larger problem in clinical research. Site training has expanded so far beyond its original purpose that it can create friction rather than reduce it, even for highly experienced sites. In some cases, that burden has become a factor in whether sites choose to participate at all.
These concerns reflect patterns raised repeatedly in site advisory discussions and cross-sponsor forums, including exploratory work we undertook as members of TransCelerate, a nonprofit catalyst for change in clinical research. Through this open dialogue, we had the opportunity to examine how training expectations accumulate, to see how they affect execution at the site level, and to consider the path forward.
The Training Paradox
Clinical trial sponsors invest heavily in training to mitigate risk and ensure data quality — goals that sites fully support. The current approach, however, can work against those intentions. When sites navigate hours of repetitive content, important protocol-specific details can get lost in the noise. And as training curriculums expand with generic material, it becomes harder for teams to identify and focus on the critical points that actually distinguish one study from another and are essential to data quality.
The pattern is familiar to most sites. They complete similar training modules for multiple sponsors. Staff members work through EDC training for systems they won't access in their roles. This creep in training burden often stems from training matrices that aren’t mapped to actual site responsibilities and staff knowledge levels, defaulting, instead, to a mandatory-for-all approach. Principal investigators report that training requests can consume significant time per study, much of it covering procedures already central to their clinical practice. Without clear measures of burden or effectiveness, modules persist by inertia.
Based on site feedback shared in advisory group settings, the cumulative training burden has, in some cases, begun to influence decisions about study participation and has contributed to longer start-up timelines.
When Training Becomes Disconnected From Its Purpose
Training programs often expand for understandable reasons. When something goes wrong during a study, adding another module can feel like a quick, defensible response. It’s visible and auditable. It signals action. Over time, that instinct reshapes training into a catch-all solution. New training is layered on to address isolated issues, even when the underlying cause lies elsewhere — in protocol design, system complexity, or unclear handoffs. Training grows, but not always in the places that would most improve execution.
The effect is cumulative. Content becomes broader and more generic because tailoring training to specific roles or protocol risks takes more up-front effort. What started as targeted preparation gradually turns into a long checklist of tasks, many of which are only loosely connected to how the study will be performed at a site. Training becomes less about helping a site execute the protocol and more about documenting that something was done. As that happens, the ability of training to support effective execution weakens, even as the number of required modules continues to rise. A more risk-proportionate, quality by design approach — consistent with ICH E6(R3) — offers a way to reverse this drift by focusing on what is critical to quality, fragile, nonstandard, or operationally complex.
When Site Initiation Visits Could Do More
In theory, site initiation visits (SIVs) are where training and practical execution come together. They should help teams understand how the protocol will practically run and where they may need to be especially careful to ensure data integrity. In practice, sites often report, through operational feedback and advisory discussions, that SIVs are consumed by slide presentations and one-size-fits-all system training, leaving little room to dig into the operational questions that matter most.
As a result, site teams may leave without clear answers about how to translate the protocol into their specific clinical workflow. Where are sites most likely to run into issues once the study is underway? Which procedures differ from their standard approach? How should they think about handling randomization in practice?
Timing of the SIV plays a role, too. When SIVs occur before sites have access to training portals or study systems, teams lack the ability to explore how the protocol will run at their site. Without that context, discussions remain theoretical, limiting the value of sponsor-site interaction ahead of the first patient visit.
The Path Forward: Six Practical Changes To Consider
When training is effective, sites start a study understanding the critical-to-quality factors and knowing where possible risks to achieving data integrity and patient safety are lurking, and they know how to respond with pre-identified mitigations. These practical changes could help to more meaningfully support sites as they prepare to execute studies:
- Focus training on what's truly protocol-specific: Training adds the most value when it focuses on what is critical to quality, different, fragile, or operationally complex in a specific study. Anchor training to a protocol risk assessment and critical-to-quality factors. Training should focus not on standard care of patients but on protocol-specific challenges: where this study departs from routine practice, which assessments have downstream consequences, and where execution typically breaks down. When training tries to cover everything, the things that really matter get buried.
- Recognize existing qualifications and experience: Most site staff operate under professional licensure and ongoing regulatory oversight. Training that ignores this baseline can feel dismissive of genuine expertise. Where relevant knowledge needs verification, consider using brief competency assessments to confirm understanding rather than requiring experienced staff to repeat extensive modules on familiar material. Offer test-out pathways for routine systems and processes, allowing experienced staff to demonstrate proficiency and skip redundant training, so they can focus on site-specific changes, updates, and genuinely new content.
- Use SIVs to focus on practical execution: SIVs work best when they involve team members who can speak to the reasoning behind protocol design and walk through how execution will unfold in practice. Structure SIVs to allow for simulations of the end-to-end patient journey, randomization steps, sample logistics, adverse event documentation, and data entry. Mock scenarios, discussion of edge cases, and time for substantive questions tend to prepare sites more effectively than slide-by-slide presentations. The goal is to help teams understand how the study will work at their site. That means going beyond reviewing protocol requirements to discussing practical execution.
- Create space for hands-on preparation: Sites consistently point to the value of working through key workflows before a study goes live. Access to test or sandbox environments — for data entry, randomization steps, or other critical systems — allows teams to rehearse scenarios and identify friction points early. This kind of preparation is particularly helpful for complex protocols or significant amendments. Clear expectations around these environments’ availability help strike the balance between training that is too early to be useful and training that arrives too late to prevent issues.
- Tailor training to actual roles and responsibilities: Not every team member needs identical training. Study coordinators may not need extensive training on systems they won't use. Pharmacists may not need the same content as nurses. Role-specific modules help ensure staff spend time on what's relevant to them.
- Avoid amendment churn: Emphasize training for amendments by teaching only what has changed, not rerunning the entire curriculum. Use brief microlearning modules that isolate the new steps or parameters, paired with short scenario-based knowledge checks to confirm understanding, and distribute updates only to the roles impacted.
An Opportunity To Strengthen Site Partnerships
By the time a study reaches a site for execution, complexity shows up in determining participant visit schedules, handoffs between staff and departments, system logins, and decisions made by both site staff and sponsors under time pressure. Training either equips teams for those moments or becomes another obstacle. Right now, we're operating on the assumption that the extensive training provided to sites produces better outcomes. But that is not always what happens. When training respects what people already know and concentrates on what's critical to quality, genuinely new, or likely to cause friction, they're better prepared. When it doesn't, we're burning time, credibility, and goodwill.
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