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.

E

Ethics committee

An ethics committee is an independent body established in a Member State in accordance with national law and empowered to give opinions for the purposes of the Clinical Trials Regulation 536/2014, taking into account the views of laypersons, in particular patients or patients' organisations (Art. 2(2)(11) CTR). Its role is to protect the rights, safety, dignity and well-being of subjects by reviewing the protocol, the informed consent documents, investigator suitability, recruitment arrangements and compensation.

Names and structures vary: Comités de Protection des Personnes (CPP) in France, Ethik-Kommissionen in Germany, Research Ethics Committees under the Health Research Authority in the UK, and Institutional Review Boards (IRBs) in the United States. Under the CTR, the ethics committee opinion is integrated into the Member State's single decision delivered through CTIS, with Part II of the assessment (including consent and data protection documents) falling largely within its remit.

Ethics committees increasingly examine data protection compliance: whether the informed consent form contains the Art. 13 GDPR information, whether international transfers are disclosed, and whether re-contact and future use of data and samples are properly framed. A favourable ethics opinion is not a substitute for GDPR compliance, but discrepancies between ethics submissions and the DPIA are a frequent source of findings, so both should be prepared together. See iliomad's ICF review services.

Is an ethics committee’s favourable opinion the only approval a study may need?

No. Ethics review is one part of the applicable approval framework. For EU medicinal-product trials, the CTR combines scientific and ethical review within the authorisation process. Other permissions or compliance steps may also apply to the study’s data, sites or activities. Map them before recruitment rather than assuming one favourable opinion covers everything.