Considerations for eCOA in Global Clinical Trials
Regulatory Considerations for eCOA Submissions in Global Clinical Trials: What You Need to Know
When managing eCOA in clinical trials across multiple countries, translation, linguistic validation, and electronic implementation of Clinical Outcome Assessments (COAs) are key elements to consider. eCOA adds additional steps and timelines to the process, which can often create confusion around regulatory requirements for submissions. In the United States, submissions are made to the Institutional Review Board (IRB), while in the rest of the world they are made to Ethics Committees (ECs). All sponsors planning a global trial know it, but they often find that regulatory guidance isn’t uniform. In some areas, guidelines are open to interpretation and requirements vary by country.
Proactive Study Planning
Proactive study planning is one way to make the submissions process go more smoothly. When COAs require licensing and/or translation and linguistic validation, delays in instrument availability can quickly impact site activation, patient enrollment, and overall study timelines. During protocol development, study teams should identify whether existing validated translations exist already or need to be developed. If development is needed, getting started on that process for any languages that might be in scope for the study can help get ahead of the eventual submission timelines.
Understanding Your Needs
Running a global trial means managing eCOA translation requirements or guidelines from several different bodies, not all of which want the same thing. Whether submissions are handled in-house by the sponsor or outsourced to a contract research organization (CRO), it’s important to have a clear submissions strategy. Sponsor oversight also remains critical, even when other vendors are involved. For example, in the US, FDA expectations for clinical outcome assessment review have evolved, and sponsors should ensure their documentation aligns with current agency thinking.
Successful eCOA submissions start with documentation planning. Teams should identify upfront which materials regulators may request, including system validation documentation, user acceptance testing records, vendor qualification materials, instrument licensing agreements, screenshots, audit trail capabilities, translations, etc.
Some EC/IRB requirements are clear and objective. Others, like many industry regulations, are open to interpretation. This leads individual pharmaceutical, biotechnology, and CROs to each develop their own customized strategy for handling submissions, including what materials to include in the package. These strategies are largely based on the company’s comfort with risk as well as experience from past trials.
One particular area of confusion surrounds “patient-facing documents” and what exactly that entails in many regions and countries. For many regulatory submissions, there are misinterpretations regarding what is actually required to satisfy the requirement, which often leads to unnecessary materials being submitted.
For teams running eCOA clinical trials, aligning early on documentation scope and submission strategy can prevent avoidable delays later in start-up.
The European Case Study
The European Union’s Clinical Trials Regulation 536/2014 (EU CTR) and its submission process via the Clinical Trials Information System (CTIS) aim to simplify submissions. However, despite Q&A clarifications, confusion remains around “patient-facing documents,” including what must be submitted and when.
There is a common interpretation that submissions should include final versions of eCOA screenshots because they are patient documents. However, in 2020, the eCOA Consortium argued that these requirements have been misinterpreted and that ECs/IRBs do not require all written material presented to trial participants, but only materials related to consent and recruitment. Per the Consortium, eCOA screenshots are used for clinical data capture and do not need to be included in submissions.
In the EU CTR Q&A document, there are a few areas of particular interest on clarifying this topic:
- Line 81 verifies that there is “no legal basis in the CTR to request submission of all patient-facing documents in the Part II documentation package and/or to require their translation.”
- Lines 79 and 81 clarify that final screenshots are not required as part of Part II submissions.
The Q&A is not legally binding, and individual countries can still issue country-specific requirements. However, empirical evidence suggests that eCOA screenshots are not a required part of submission documents in the EU.
Suitable Alternatives
In cases where the need to submit eCOA screenshots is more ambiguous, empirical evidence suggests there are suitable alternatives and workarounds that do not require final screenshots. In practice, some teams submit supplemental materials that are available sooner than final eCOA screenshots. For example:
- Paper COAs
- Paper COAs and English eCOA screenshots
- Draft bilingual tables showing eCOA content
- Draft eCOA screenshots
Again, these are intended as workarounds when regulators insist that eCOA screenshots be included in the submission package. Recent evidence suggests that, in many countries, regulators may not require them at all.
When to Question the Need
Despite limited evidence that final eCOA screenshots are required for submissions in many countries, the assumption that they are still needed remains common across the industry. As a result, sponsors often apply a one-size-fits-all strategy to be conservative, mitigate perceived risk, and limit variation. However, this approach can delay overall study timelines if teams wait for final eCOA screenshots when submissions could proceed without them in most or all countries.
When study timelines are tight, study teams should question the notion that final eCOA screenshots, or any screenshots at all, are needed for submissions, especially for European countries. Sponsors should work with their Providers to determine what is needed and any potential workarounds that can be used to submit adequate materials, while also pushing timelines as quickly as possible.
When using a CRO for submissions, it’s important to align on strategy and ensure support is tailored by country. The CRO should understand what is required versus what is open to interpretation so the team can use appropriate, timeline-accelerating approaches where possible.
Because some of these regulations can be interpreted differently, a strategic approach to compliance can be worthwhile if it helps shorten timelines in future study workflows. Partners with extensive eCOA study experience can also bring empirical evidence to help you evaluate options and workarounds for regulatory submissions.
Conclusion
As study start-up timelines continue to compress, every day matters. In electronically administered studies, eCOA screenshots are typically the last step in the COA workflow, so waiting for them before submitting a package can cause significant delays.
When country guidance is unclear or open to interpretation, it’s often worth questioning whether final eCOA screenshots are truly required for submission. With the right research and, where appropriate, outreach to regulatory agencies, study teams can develop a strategy based on actual requirements rather than assumptions.
TransPerfect's COA Solutions practice is built around your independence. For sponsors seeking comprehensive eCOA solutions, having an experienced partner who understands the nuances of regional requirements is critical. Speak with a COA expert about your regulatory submission strategy and eCOA needs.