Briefings, white papers, and guides on the rules and data behind hospital research, with every fact sourced.
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Article
Hospitals run two operations: care and research. Care is gaining its own operating systems. Research still runs on whatever each sponsor sends, while Europe loses trial share, shortens authorisation, and gives hospitals data-holder duties from 2029. Hospitals should own the operating layer of their research. Six requirements define that layer.
Daren Wilson
Accelerating Clinical Trials in the EU, the joint initiative of the European Commission, national medicines agencies, and the European Medicines Agency to make the EU more attractive for clinical research. It sets and tracks 2030 targets.
The data integrity principles regulators expect of trial records: attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available.
Processing that makes it no longer possible to identify the person a record describes, by any means reasonably likely to be used. Anonymised data falls outside the GDPR.
A secure, computer-generated, time-stamped record of who created, changed, or deleted an electronic record, when, and why. Inspectors rely on it to reconstruct what happened in a trial.
A collection of human biological samples, such as blood or tissue, stored with linked data and consent records so the samples can be used in future research.
The document, paper or electronic, in which a site records the data a trial protocol requires for each participant. An electronic version is an eCRF.