Click here to open the filter panel
#
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
Analysis Data Model (ADaM)
A
Anonymisation
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
Broad consent
B
Business associate agreement (BAA)
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 trial
C
Clinical trial agreement (CTA)
C
Clinical trial phases
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
Consent
C
Contract research organisation (CRO)
C
Controller
C
Cookies
C
Cross-border processing
D
Data Act
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
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
Encryption
E
End of a clinical trial
E
Enterprise
E
Ethics committee
E
EU Artificial Intelligence Act (AI Act)
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)
E
Explicit consent
F
Fairness and transparency
F
Federated learning
F
Filing system
F
First-in-class drugs
F
Food and Drug Administration (FDA)
F
Fundamental rights impact assessment (FRIA)
G
General Data Protection Regulation (GDPR)
G
General-purpose AI model (GPAI)
G
Genetically modified organism (GMO)
G
Genetic data
G
Global public health security
G
Good clinical practice (GCP)
H
Health data warehouse (HDW)
H
High-risk AI system
H
HIPAA (Health Insurance Portability and Accountability Act)
H
Human oversight (AI Act)
H
Human subjects protection review board
C
Imported item 10
S
Imported item 11
C
Imported item 12
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.

C

Imported item 25

A clinical study report (CSR) is a detailed account of a clinical study’s methods, conduct, analyses and results. ICH E3 provides a recognised structure for reports submitted to regulatory authorities. A CSR is more extensive than a journal article and may contain information requiring protection before public disclosure.

Key Takeaways

  • ICH E3 provides a reporting structure, not proof that a study’s conclusions are valid.
  • The regulatory master and the public disclosure version serve different purposes.
  • Check the relevant CTIS or EMA publication requirements rather than assuming every CSR follows one route.

What Does a CSR Cover?

ElementMeaning
Study contextObjectives, design, ethics and participants
MethodsTreatments, statistical plan and analyses
ResultsEfficacy, safety, interpretation and appendices

ICH E3 addresses the organisation of clinical study reports so that study design, conduct and findings can be evaluated coherently. A report should allow a reviewer to understand the methods behind the results rather than relying on a brief conclusion. EMA’s Policy 0070 framework includes clinical study reports within its applicable publication scope. CTIS has a separate transparency workflow. Neither point means that every complete regulatory report, including every attachment, is automatically made public without a scope and confidentiality assessment.

Primary guidance: EMA ICH E3 guideline; EMA clinical data publication.

Why It Matters for Data Protection

For a hypothetical rare-disease study, we recommend reviewing narratives and appendices alongside the main report before preparing a public version. A combination of age, location, dates and unusual clinical history may disclose more than any one field suggests. Maintain a clear link between the regulatory master, the transformed disclosure copy and the justification for changes. Review consistency across tables, listings and narrative text after transformation. Assign responsibility for checking scientific usefulness as well as privacy, so that protection measures do not leave a report that readers can no longer interpret reliably.

Frequently Asked Questions

Is a CSR the same as a publication?

No. A journal article is usually a shorter, separately prepared account.

Does ICH E3 determine publication timing?

No. Check the applicable regulatory transparency mechanism.

Should the regulatory master be redacted?

Keep the complete regulatory record distinct from any copy prepared for public disclosure.

Related reading: clinical trials information system ctis; CTIS privacy guide for sponsors.

Explore iliomad’s clinical trials support for your organisation.

Updated: 27 October 2026