Why Paper Consent Is Your Bottleneck in eCOA Clinical Trials
In contemporary clinical trials that use electronic clinical outcome assessments (eCOA), the traditional paper-based informed consent process can be inconsistent with modern digital standards. This may be a significant source of friction and risk. For organizations that have adopted digital data capture, the perceived ease of paper consent can be misleading, as FDA, OHRP, EMA have long permitted electronic consent, including remote use, precisely to streamline these steps.1,2
More recently, ICH GCP E6 (R3) explicitly permits eConsent for the first time.3 The perceptions around regulatory ambiguity and the ‘ease’ of paper consent can mask considerable costs to timelines, data integrity, and the patient experience. In a digitally native study, paper may not represent the easier choice, but rather a systemic weakness.
The Foundational Disconnect: When Paper Meets a Digital Workflow
When a digital patient journey begins with a pen and a clipboard, a fundamental disconnect can be created that causes inefficiency across the trial lifecycle. This analog step in an otherwise digital process introduces many predictable challenges.
Manual Process Delays
Site staff must verify paper consent is complete before a patient can be provisioned a device or granted access to an eCOA application, creating a potential bottleneck to enrollment. Regulations require legally effective consent before any study-specific procedures (including eCOA capture or device/app provisioning). (FDA 21 CFR Part 50.20)
Operational Redundancy and Error
Staff are tasked with parallel workflows, sometimes requiring them to scan, upload, and transcribe information from paper forms. This manual data re-entry can duplicate effort and introduce a high risk of transcription errors, compromising data quality. Paper-based oversight is more challenging to centralize and is often delayed until monitoring cycles or manual uploads, while eConsent eliminates these risks by providing immediate, centralized dashboards with time-stamped audit trails based on data captured correctly at the source.
Fragmented Patient Experience
The patient must switch between digital and in-person interactions, creating an inconsistent experience that can undermine engagement—particularly in decentralized or hybrid trials where seamless technology is paramount.
Relying on a paper process in a digital trial framework can inject inefficiency, risk, and human error into your study.
Achieving Seamless Integration: The Power of Unified eConsent and eCOA
The solution is not to scale back digital adoption, but instead to fully integrate it. By integrating eConsent directly within the eCOA ecosystem, the entire clinical trial process becomes unified and streamlined. This is the principle upon which Medidata Consent was re-engineered—a solution co-designed with our Patient Insights and SiteTech boards to serve the needs of patients, sites, and sponsors. Medidata Consent automatically populates Rave EDC with consented patient metadata, out of the box.
When Consent and eCOA are unified on a single platform, the advantages become clear:
- For Patients: The onboarding experience is more seamless. Patients use a single application on one device for both consent and assessments. Complex information is clarified through pre-consent access to documents, multimedia content, and conversations with site staff prior to coming into the site for their initial consent visit. This improves comprehension and engagement.
- For Sites: Administrative burdens are significantly reduced. With Rave EDC, the native integration removes the need for data entry to be done multiple times. Automated version control and digital workflows also free up staff to concentrate on patients rather than paperwork or duplicative data entry.
- For Sponsors and CROs: Real-time oversight becomes possible. With digital time-stamping, version control, and a comprehensive audit trail, you gain immediate insight into consent status throughout the entire study, helping ensure you’re audit-ready by design.
Engineered for Modern Trial Complexity
A modern Consent solution must be as flexible as the trials it supports.
AI-assisted configuration can significantly reduce build effort and timelines; early experiences suggest large reductions, though impact varies by study.
The system is designed to natively handle intricate study designs, including pediatric assent with distinct workflows for different age cohorts and parent/LAR co-signatures, multi-arm trials, and re-consenting scenarios.
Built to meet rigorous global regulatory demands, the platform supports eIDAS-compliant signatures, including qualified electronic signatures (QES) via qualified trust service providers, where required; (signature level varies by Member State and system context). For instances where a wet-ink signature is unavoidable, our hybrid solution allows sites to conveniently scan and upload the paper form, ensuring every patient's consent status is tracked within a single, unified system of record. This also allows site personnel to be notified when patients signed on paper require re-consent.
Beyond Simplicity: Overcoming Systemic Fragility
The clinical trial industry is moving toward a digital-first and decentralized future. In this ecosystem, relying on paper consent doesn’t preserve simplicity but can introduce fragility. Paper can reduce operational efficiency and lead to regulatory exposure—working against the value of your digital investments.
You’ve already embraced the potential of digital data capture using eCOA. A logical next step is synchronizing your consent process with that contemporary framework. Incorporating eConsent into your digital trial strategy is not disruptive; it’s a logical extension that safeguards your investment and can accelerate your journey to results. Contact us to learn more about the latest innovations developed to elevate the user experience for sites and patients.
References:
- FDA & OHRP – Electronic Informed Consent Guidance (2016)
Use of Electronic Informed Consent in Clinical Investigations – Questions & Answers
https://www.hhs.gov/ohrp/news/announcements-and-news-releases/2016/use-electronic-informed-consent-clinical-trials/index.html
- EMA – Guideline on Computerised Systems and Electronic Data in Clinical Trials (2023)
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf - ICH – GCP E6(R3) Final Guideline (Adopted January 6, 2025), including Section 2.8 (Informed Consent, remote & electronic)
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
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