Developments that affect clinical research data management — funding and
policy, regulation, standards, workforce, research, philanthropy, and
technology. We summarize what changed and why it matters, link to the
original source, and stay analytical rather than partisan: our
editorial policy
explains how we cover policy and funding news.
Practice & Standards
International Council for Harmonisation (ICH)
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January 6, 2025
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International (ICH regions)
ICH adopted E6(R3), the revised Good Clinical Practice guideline, in January 2025, superseding E6(R2). The revision restructures GCP into overarching principles plus Annex 1 for interventional trials, and gives data governance a dedicated section covering the responsibilities of sponsors and investigators across the data life cycle — computerized systems, traceability, access, and protection of blinding. The guideline is written to be media-neutral, and it treats quality-by-design and risk-proportionate approaches as organizing expectations rather than options. Regulators in each ICH region implement the guideline on their own timelines.
Why it matters
This is the first top-to-bottom rewrite of GCP since 1996, and it speaks the language of data management directly: data governance and life-cycle data integrity are now explicit GCP, not implications drawn from it. Data managers should map current SOPs — especially around computerized systems, audit trail review, and data corrections — against Annex 1's data governance section, and track when each regulator they answer to adopts E6(R3) into local requirements.
International standards body guideline · Topics: Good Clinical Practice, ICH E6(R3), data governance, quality by design · Checked September 1, 2026 ·
Read the original at International Council for Harmonisation (ICH) (external link)
Regulation
U.S. Food and Drug Administration
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October 2, 2024
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National (U.S.)
FDA issued the final question-and-answer guidance "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations," superseding the 2007 "Computerized Systems Used in Clinical Investigations" guidance. It addresses how Part 11 and related requirements apply to current trial conduct: electronic records and systems used by sponsors and sites, IT service providers and cloud hosting, data from real-world data sources and digital health technologies, audit trail expectations, validation proportionate to risk, and acceptable electronic signature methods.
Why it matters
Part 11 questions consume a disproportionate share of vendor-selection and audit conversations, and this guidance is now the reference point. It gives current, citable answers on cloud-hosted systems, audit trails, and what validation should mean in proportion to risk — useful both for qualifying systems and for resisting compliance theater. Teams whose SOPs still cite the 2007 computerized-systems guidance should update references and revisit the assumptions built on it.
Federal agency final guidance · Topics: 21 CFR Part 11, electronic records, electronic signatures, system validation · Checked September 1, 2026 ·
Read the original at U.S. Food and Drug Administration (external link)
Technology & Data
U.S. Food and Drug Administration
·
December 22, 2023
·
National (U.S.)
FDA's final guidance "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations" covers using DHTs — wearables, sensors, apps, and other connected tools — to collect trial data from participants remotely. It addresses selecting technologies that are fit-for-purpose, verification and validation, participants' own devices versus sponsor-provisioned ones, defining endpoints from DHT-derived data, and where source data resides when measurements flow from a device into a durable electronic repository, along with expectations for managing transmission, storage, and access.
Why it matters
Remote acquisition moves data management upstream: fitness-for-purpose, provenance, and transmission integrity get decided before first patient in, not fixed during cleaning. The guidance gives data managers standing to join DHT selection early, and its treatment of source data and durable repositories is exactly the kind of detail that should shape the data management plan for any study using sensors or bring-your-own-device designs.
Federal agency final guidance · Topics: digital health technologies, wearables and sensors, source data, decentralized trials · Checked September 1, 2026 ·
Read the original at U.S. Food and Drug Administration (external link)
Funding & Policy
National Institutes of Health
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January 25, 2023
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National (U.S.)
NIH's Data Management and Sharing (DMS) Policy took effect January 25, 2023, replacing the 2003 data sharing policy. Applications for research expected to generate scientific data must include a DMS plan covering data types, standards, repositories, timelines, and access and reuse considerations — regardless of budget size, unlike the prior policy's $500,000 threshold. Compliance with the approved plan is a term and condition of the award, and reasonable data management and sharing costs may be budgeted.
Why it matters
For NIH-funded teams, data management planning is now a condition of funding rather than a good habit. The plan written at application time constrains repository choice, standards, de-identification, and retention for the life of the study — so the people who will actually run the study database should help write it, and curation and sharing costs should be claimed in the budget rather than silently absorbed.
Federal agency policy · Topics: NIH, data sharing, data management plans, grant policy · Checked September 1, 2026 ·
Read the original at National Institutes of Health (external link)
We summarize and link — we do not republish. Statistics are taken from
the linked source, read before summarizing, with the date we checked
shown on each item. Corrections follow our
editorial policy.