Terms research hospitals meet.

Plain definitions for clinical trials, health data, and research infrastructure, with the source wherever a rule applies.

From ACT EU to whole slide imaging.

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21 CFR Part 11: The United States FDA regulation setting the conditions under which electronic records and electronic signatures are treated as equivalent to paper records and handwritten signatures.See also EU Annex 11

A

ACT EU: 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.See also Clinical Trials Regulation
ALCOA+: The data integrity principles regulators expect of trial records: attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available.See also Audit trail
Anonymisation: 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.See also Pseudonymisation
Audit trail: 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.See also ALCOA+, EU Annex 11

B

Biobank: 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.See also Registry

C

Case report form (CRF): 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.See also Electronic data capture
Clinical site operating system: Software owned by the hospital that runs its research operation across every study and sponsor: start-up, site files, data capture, visits, participant contact, monitoring, and the audit trail.See also Scientific and research data hub
Clinical Trials Regulation: Regulation (EU) No 536/2014, which governs how clinical trials of medicines are authorised and run in the EU. It has applied since 31 January 2022, with one submission through CTIS.See also CTIS
CTIS: The Clinical Trials Information System, the single EU portal and database through which sponsors submit trial applications and authorities assess them under the Clinical Trials Regulation.See also Clinical Trials Regulation

D

Data permit: Under the EHDS, the decision by a health data access body that allows a named user to process specified health data for a stated secondary purpose, inside a secure processing environment.See also Health data access body
Data sovereignty: The principle that data stays under the control and legal jurisdiction of the organisation that holds it. For a hospital, it means deciding where research data sits and who may use it.See also Hospital-controlled deployment
DICOM: Digital Imaging and Communications in Medicine, the international standard for storing and exchanging medical images such as CT and MRI scans, together with their metadata.See also Whole slide imaging

E

eConsent: Informed consent given and recorded electronically, often with multimedia information, identity checks, and electronic signatures, in place of or alongside a paper form.See also eSource
Electronic data capture (EDC): Software for recording trial data electronically, usually provided by the sponsor for one study. Site staff enter data into it from the participant's source records.See also Case report form, eSource
eSource: Data captured electronically at its first point of recording, such as in the health record or a site system, so it does not have to be transcribed again into the trial database.See also Electronic data capture
EU Annex 11: Annex 11 of the EU guidelines on Good Manufacturing Practice, setting expectations for computerised systems: validation, audit trails, security, and electronic signatures. Applied to clinical systems alongside EMA guidance.See also 21 CFR Part 11
European Health Data Space (EHDS): Regulation (EU) 2025/327. It gives people access to their health data across borders and creates rules for its secondary use in research, innovation, and policy. It entered into force in March 2025.See also Health data holder

F

Federated analysis: Analysis in which the data stays at each institution and only the query and aggregated results move between sites, so no patient-level records leave their source.See also OMOP
FHIR: Fast Healthcare Interoperability Resources, the HL7 standard for exchanging health data between systems through defined resources and web interfaces.See also OMOP

G

Good Clinical Practice (GCP): The international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving people. Its current version is ICH E6(R3).See also ICH E6(R3)

H

Health data access body: The national authority under the EHDS that assesses requests to use health data for secondary purposes, issues data permits, and asks data holders to make the data available.See also Data permit
Health data holder: Under the EHDS, an organisation, such as a hospital, that processes personal electronic health data as a controller. It must describe its datasets and supply data when an access body requests it.See also Health data access body
HealthDCAT-AP: A metadata profile for describing health datasets in a common, machine-readable form, developed in the Commission-funded HealthData@EU pilot and used to prepare the descriptions that European health dataset catalogues hold.See also Health data holder
Hospital-controlled deployment: Running software on infrastructure the hospital controls, on its premises or in a private cloud it chooses, rather than on a vendor's shared service.See also Data sovereignty

I

ICD-O-3: The third edition of the International Classification of Diseases for Oncology, published by the World Health Organization, which codes a tumour's site and its histology.See also Orpha codes
ICH E6(R3): The current revision of the ICH guideline for Good Clinical Practice. Its principles and Annex 1 apply in the EU from 23 July 2025.See also Good Clinical Practice
Investigator site file (ISF): The essential documents a trial site keeps to show the trial was run correctly: approvals, protocol versions, delegation logs, training records, and consent forms. An electronic version is an eISF.See also Audit trail
Investigator-initiated trial: A study designed and run by a hospital or academic investigator, who takes the sponsor's responsibilities, rather than by a pharmaceutical or device company.See also Sponsor

O

OMOP: The Observational Medical Outcomes Partnership common data model, maintained by OHDSI. It lets health data from different sources be analysed with the same queries and is used in federated networks.See also Federated analysis
Orpha codes: Identifiers from Orphanet, the reference nomenclature for rare diseases. They give each rare disease a stable code, so registries across countries can be compared.See also ICD-O-3

P

Pseudonymisation: Replacing direct identifiers with a code, so records cannot be linked to a person without separately held information. Pseudonymised data is still personal data under the GDPR.See also Anonymisation

R

Registry: An organised, long-term collection of standardised data about people with a particular disease, condition, or treatment, used for research, quality improvement, and planning care.See also Biobank

S

Scientific and research data hub: A governed layer inside the hospital that holds research records from its systems under one permission model and one audit trail, ready to describe, analyse, and release on the hospital's terms.See also Clinical site operating system
Secondary use: Using health data for a purpose other than the care it was collected for, such as research, innovation, policy-making, or training and testing AI systems.See also European Health Data Space
Secure processing environment: A controlled technical environment in which approved users analyse health data under the EHDS. They work on anonymised or pseudonymised data and can take out only non-personal results.See also Data permit
Site activation: The steps between a site being selected for a trial and being ready to enrol: feasibility, contract and budget, local approvals, set-up, training, and the site initiation visit.See also Site initiation visit
Site initiation visit: The meeting, on site or remote, at which the sponsor or its monitor confirms a site is trained and ready, and the trial can start enrolling.See also Site activation
Source data verification: Checking that the data entered for a trial matches the original source records, such as the medical record. Monitors may do it on site or remotely.See also eSource
Sponsor: The person, company, or institution that takes responsibility for starting, managing, and financing a clinical trial. In investigator-initiated trials, the hospital or investigator is the sponsor.See also Investigator-initiated trial

W

Whole slide imaging: Scanning an entire glass pathology slide at high resolution to create a digital image that can be viewed, annotated, and analysed on screen.See also DICOM

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