eCF News:

1. Don’t forget to register for the 2026 Autumn Workshops

Registrations are still open for this year’s Autumn Workshops! You can find a high-level draft agenda on our website here. Keep an eye out for each region’s Preliminary Agenda, which will include workshop topics and speakers, and will be released next week. Whether you plan on attending in person or online, as a guest or as a speaker, don’t forget to register! 

• Americas: 13.-15. October 2026, hosted by GenInvo in  Bloomington, Illinois, USA. REGISTER
• APAC/Hybrid: 22.-23. October 2026, hosted by Clario in Shanghai, China. REGISTER
• Europe/Hybrid: 27.-29. October 2026, hosted by BSI Life Sciences in Zurich, Switzerland. REGISTER

Anyone from our member companies can register for remote participation in the hybrid workshops for free, regardless of seat availability and location. For in-person attendance, each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. 

2. Get the public release of the Computerised Systems Essential Records (CSER) List

Earlier this month, we released the public version of the Computerised Systems Essential Records (CSER) List. It can now be downloaded for free -by members and non-members alike. 

When it comes to ensuring a clinical trial can be accurately reconstructed after a system is decommissioned, a clear and structured definition of essential records, data and metadata elements is key. Ultimately, identifying these elements, designating them for long-term archival, and confirming that they have been properly archived is an important sponsor responsibility. 

That’s where the Computerised Systems Essential Records (CSER) List comes in. It’s designed to help sponsors identify, select and document the essential data and metadata that should be retained when a clinical trial is archived and a computerised system is decommissioned. It can be used as a practical reference for identifying:

• Study-specific essential records
• System-specific metadata requirements
• Audit trail elements needed for compliance

This list is not meant to be a one-size-fits-all checklist, but rather a foundation which users can adapt and expand to fit their own requirements. If you’re working with clinical trial data, system decommissioning or long-term archival, download the CSER List and check out our Essential Records Dashboard here. 

 3. Read our newest DHT article “Five data privacy failure points in DHT-enabled clinical trials - and how to close them”

You can decentralize data collection. You cannot decentralize liability. Our latest eClinical Forum DHT Working Group article identifies the five failure points where sponsor accountability and privacy reality most often diverge: re-identifiable sensor data, incomplete DPA coverage, privacy notices that fail participants in practice, unmapped cross-border transfers, and unenforced deletion obligations. Each with concrete "do this" actions and a regulatory quick reference spanning GDPR, EU CTR, HIPAA, and PIPL. If you’re curious to learn more, check out the article on Linkedin.

4. Recap: eCF Webinar “Exploring ICH E6 (R3) Annex 2 for Decentralized Trials and Real-World Data”

Are you interested in the implications of Annex 2 for the future of clinical trials, but couldn’t make this month’s eCF Webinar? Have a look at the webinar recoding, which is now available online to all our members. The webinar featured valuable, industry-based insights from our five presenters, and explored key considerations for Decentralized Clinical Trials (DCTs) and Real-World Data (RWD) such as practical challenges and emerging requirements for data quality and oversight. 

eCF Views: 

What’s new in the world of clinical research? Any questions you urgently need answers to, or topics that keep you up at night?  Share them with your fellow eCF members on our eCF Discussion Forum. 

1. AI in Trials: The Problem Is Disclosure, Not Capability

A commentary published this week makes an uncomfortable but fair argument. The conditions under which AI earns trust in statistical and adaptive design workflows are validated knowledge bases, transparent context engineering, and formal evaluation criteria applied before output reaches a decision-maker. These are the minimum conditions for any analytical tool in a GCP-regulated environment. The gap between that standard and what many organisations are actually deploying is where risk accumulates quietly. QA and vendor qualification teams may find the framing a useful one to borrow.

 AI in Clinical Trials Doesn't Have a Capability Problem, Clinical Trial Vanguard, September 2026

2. RBQM Now Has a Financial Case, and the Authors Are Candid About What It Excludes

A peer-reviewed study by Tufts CSDD and CluePoints, published in the September 2026 issue of Therapeutic Innovation & Regulatory Science, models RBQM's financial return using real-world data from 18 oncology trials against Tufts benchmarks. It reports phase duration reductions of 8 to 19 percent, trial-level returns from $3.2M in Phase I to $18.9M in Phase III, and ROI multiples of 6x to 23x, with time savings rather than monitoring cost cuts as the primary driver. In a follow-up interview published September 4, the authors note what the model deliberately excluded, including reduced rework, improved data integrity, inspection readiness, and first-time implementation costs such as training, SOP updates, and data integration. Read the exclusions as carefully as the headline number.

 Dirks A, de Viron S, McFarlane K, Getz KA. Ther Innov Regul Sci2026;60(5):1513–1519. DOI: 10.1007/s43441-026-01002-1 | Follow-up interview, Applied Clinical Trials, September 4, 2026

3. Patient-Centricity Is Still Mostly Consultative

A September 4 piece in Applied Clinical Trials argues that patient-centricity in most clinical research remains largely consultative, while rare disease communities demonstrate that genuine partnership from protocol inception improves feasibility, reduces unnecessary burden, and surfaces outcomes that actually matter to participants. Annex 2 formalises GCP expectations around decentralised and pragmatic designs, where participant burden becomes a design variable rather than an afterthought. That makes the distinction between consulting patients and partnering with them a practical trial design question.

 Applied Clinical Trials Online, September 4, 2026

These articles are not endorsed by the eCF and don’t necessarily represent our own views

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. Please feel free to forward this email to your colleagues. Please let us know if colleague(s) want to be added to this monthly distribution!

Your eCF facilitators are always interested in what you have to say …

Wolfgang.Summa@eClinicalForum.org, Sean.Higashio@eClinicalForum.org, Jana.Summa@eClinicalForum.org, Tom.Haag@eClinicalForum.org.