Click here to open the filter panel
#
21 CFR Part 11
#
510(k) premarket notification
A
Accountability
A
Accuracy
A
Adequacy decision
A
Ad hoc services
A
Adverse event
A
AI literacy (Art. 4 EU AI Act)
A
AI Officer
A
ALCOA+
A
Analysis Data Model (ADaM)
A
Anonymisation
A
APPI (Japan's Act on the Protection of Personal Information)
A
Appropriate safeguards
A
Article 29 Working Party (WP29)
A
Artificial intelligence (AI)
A
Authorised representative (EU AI Act)
A
Automated individual decision-making
A
Auxiliary medicinal product
B
Best-in-class drugs
B
Binding corporate rules (BCR)
B
Biobank
B
Biometric data
B
Biotechnology
B
Blinding and unblinding
B
Breakthrough therapy designation
B
Broad consent
B
Business associate agreement (BAA)
C
CDASH (Clinical Data Acquisition Standards Harmonization)
C
CDISC
C
Central imaging
C
Central laboratory
C
Chemistry, Manufacturing and Controls (CMC)
C
Clinical outcome assessment (COA)
C
Clinical research
C
Clinical study
C
Clinical study report (CSR)
C
Clinical trial
C
Clinical trial agreement (CTA)
C
Clinical trial phases
C
ClinicalTrials.gov
C
Clinical Trials Information System (CTIS)
C
Clinical trial site
C
Clinical Trials Regulation (CTR) 536/2014
C
Clinician-reported outcome (ClinRO)
C
CNIL (Commission nationale de l'informatique et des libertés)
C
Codes of conduct
C
Common Rule (45 CFR 46)
C
Common Technical Document (CTD)
C
Companion diagnostic
C
Conformity assessment (MDR & AI Act)
C
Consent
C
Contract research organisation (CRO)
C
Controller
C
Cookies
C
Covered entity (HIPAA)
C
CPRD (Clinical Practice Research Datalink)
C
Cross-border processing
D
Data Act
D
Database lock
D
Data concerning health
D
Data Governance Act (DGA)
D
Data management plan (DMP)
D
Data minimisation
D
Data monitoring committee (DMC)
D
Data processing agreement (DPA)
D
Data protection authority (DPA)
D
Data protection by default
D
Data protection by design
D
Data Protection Impact Assessment (DPIA)
D
Data Protection Officer (DPO)
D
Data Protection Representative (DPR)
D
Data quality
D
Data retention
D
Data subject
D
Data subject access request (DSAR)
D
Decentralised clinical trial (DCT)
D
Define-XML
D
De-identification (HIPAA)
D
Differential privacy
E
Early termination of a clinical trial
E
Electronic case report form (eCRF)
E
Electronic clinical outcome assessment (eCOA)
E
Electronic data capture (EDC)
E
Electronic health record (EHR)
E
Electronic informed consent (eConsent)
E
EMA Policy 0070
E
Encryption
E
End of a clinical trial
E
Enterprise
E
ePRO (electronic patient-reported outcome)
E
Ethics committee
E
EU AI Office
E
EU Artificial Intelligence Act (AI Act)
E
EUDAMED
E
European Data Protection Board (EDPB)
E
European Data Protection Supervisor (EDPS)
E
European Health Data Space (EHDS)
E
European Medicines Agency (EMA)
E
EU-US Data Privacy Framework (DPF)
Click a letter to view all its definitions
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

T

Temporary halt of a clinical trial

A temporary halt of a clinical trial means an interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it (Art. 2(2)(27) EU Clinical Trials Regulation 536/2014). It is distinguished from a planned pause written into the protocol (for example between dose cohorts), from early termination and from the end of the trial.

Typical reasons are an urgent safety concern, a data monitoring committee recommendation pending review, IMP supply or quality problems, or regulatory action. Under Art. 37(2) and 38 CTR the sponsor must notify the temporary halt through CTIS within 15 days, stating the reasons; where the halt is for safety reasons, urgent safety measures under Art. 54 may be taken immediately and notified within seven days. Resumption is likewise notified, and a halt exceeding two years is treated as the end of the trial. Member States may themselves suspend or revoke an authorisation under Art. 77.

Data protection obligations continue during a halt. Data already collected remains subject to retention, safety follow-up and security duties; processors continue to host and protect the data; participants must be informed about what the halt means for their treatment and their data; and if the halt leads to protocol amendments affecting data collection, the DPIA and informed consent form must be updated before resumption. Vendor contracts should address the financial and operational consequences of a suspension without triggering premature deletion of trial data.

Is a planned pause between dose cohorts a temporary halt under the EU CTR?

Not necessarily. The CTR definition of a temporary halt concerns an interruption not provided for in the protocol, where the sponsor intends to resume the trial. A planned pause may therefore be different. Check the protocol, reason and applicable reporting rules, and document the decision rather than classifying every gap in recruitment as a halt.