Can AI Write Clinical Trial Documents? What a Site Must Check
A model can draft a protocol section, a participant information sheet, a standard operating procedure or a letter to a regulator. A named person verifies the facts, approves the version and files it. This guide covers the four document classes, what the MHRA found in AI-drafted inspection responses, the seven checks before approval and what the site file holds.
How Will UK AI Regulation in Healthcare Affect Clinical Research?
The National Commission into the Regulation of AI in Healthcare published 44 recommendations on 10 September 2026, and the government accepted all of them on 6 October 2026. This guide maps the four that reach a UK research site, what Recommendation 44 asks of the HRA, and the dates that matter.
How Is AI Used in Clinical Trial Monitoring?
AI enters clinical trial monitoring in three places: centralised analytics across pooled data, drafting inside a monitoring report, and retrieval at the site. This guide covers the three monitoring modes under ICH E6(R3), how a predefined tolerance limit raises a signal, and what a UK site still evidences for source data verification.
Best eQMS for UK Clinical Research Organisations: A 2026 Comparison
The best QMS for a clinical research organisation holds several sponsors’ procedures, training records and CAPAs in one controlled core while keeping each sponsor’s records separate. This comparison records what nine eQMS vendors publish about their own products, checked on 2 November 2026.
Can AI Speed Up Clinical Trial Set-Up at a UK Site?
AI shortens the document handling inside set-up: feasibility responses, essential document collection and drafting checks. This guide maps the twelve set-up tasks at a UK site, what AI can propose for each, what stays with a named person, and what the 150-day clock actually measures.
What Is Agentic AI in Clinical Trials, and Where Must a Person Decide?
Agentic AI is software given a goal rather than an instruction, which plans its own steps and acts across systems until the goal is met. This guide separates an agent from an assistant, sets the task boundary a UK research site can defend, and names where a person must decide.
The EMA and FDA Good AI Practice Principles: What They Mean for Clinical Trials
The EMA and FDA published ten joint guiding principles of good AI practice in drug development on 14 January 2026. This guide takes each principle in turn, states what it asks of a UK research site and of a sponsor, and sets out where the ten sit against the rules a site is already legally bound by.
Is Your Research Site Ready for AI? A Readiness Checklist for UK Sites
Readiness for AI at a research site is seven things scored from nought to three: connected records, data quality at source, a named governance owner, delegation and training, validation capacity, information governance, and staff confidence. This guide gives the scored checklist, the three bands and the order to fix them in.
How Should a Research Site Govern the Use of AI?
A research site governs AI use through one written procedure covering scope, roles, approval of each new use, training, monitoring, incident reporting and periodic review. This guide sets out all seven sections, the decision each one fixes and the record it leaves behind.
Who Is Accountable When AI Gets It Wrong at a Trial Site?
Accountability for an AI-assisted error sits with people. The investigator answers for the delegated activity, the sponsor for the trial, and the vendor for the system. This guide covers the chain link by link, the delegation record, the route an error travels and what an inspector asks for.
