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E
Explicit consent
F
Fairness and transparency
F
FDPIC (Swiss Federal Data Protection and Information Commissioner)
F
Federated learning
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Filing system
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F
First-in-human (FIH) trial
F
Food and Drug Administration (FDA)
F
Fundamental rights impact assessment (FRIA)
G
General Data Protection Regulation (GDPR)
G
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G
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G
Genetic data
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Good clinical practice (GCP)
H
HDS certification (Hébergeur de Données de Santé)
H
Health data access body (HDAB)
H
Health data warehouse (HDW)
H
HHS Office for Civil Rights (OCR)
H
High-risk AI system
H
HIPAA (Health Insurance Portability and Accountability Act)
H
Homomorphic encryption
H
Human oversight (AI Act)
H
Human subjects protection review board
I
ICH E6(R3)
I
Incapacitated subject
I
Information Commissioner's Office (ICO)
I
Informed consent
I
Inspection
I
Institutional Review Board (IRB)
I
Interactive response technology (IRT)
I
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I
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International data transfer
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Joint controllers
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k-anonymity
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Key (cryptographic key and pseudonymisation key)
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L
Large language model (LLM)
L
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L
Lay summary
L
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Local site investigator
M
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M
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M
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M
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M
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M
MHRA (Medicines and Healthcare products Regulatory Agency)
N
Natural history study
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O
Observational study
O
Observer-reported outcome (ObsRO)
O
One-stop-shop mechanism and lead supervisory authority
O
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P
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P
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Purpose limitation
Q
Qualified Person for Pharmacovigilance (QPPV)
Q
Quality management system (QMS)
Q
Quasi-identifier
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Query (clinical data query)
R
Randomisation and trial supply management (RTSM)
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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

Clinical study report (CSR)

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