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E
Explicit consent
F
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F
FDPIC (Swiss Federal Data Protection and Information Commissioner)
F
Federated learning
F
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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I
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I
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J
Joint controllers
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k-anonymity
K
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L
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L
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L
Lay summary
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L
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L
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L
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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
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M
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N
Natural history study
N
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N
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O
Observational study
O
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O
One-stop-shop mechanism and lead supervisory authority
O
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P
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P
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P
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P
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P
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P
Processor
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P
Pseudonymisation
P
Purpose limitation
Q
Qualified Person for Pharmacovigilance (QPPV)
Q
Quality management system (QMS)
Q
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Q
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.

E

EMA Policy 0070

EMA Policy 0070 governs the proactive publication of clinical data submitted through specified European Medicines Agency procedures. Its clinical-report publication process aims to support transparency while protecting personal information and justified commercially confidential information. It is distinct from submitting a trial application or publishing information through CTIS.

Key Takeaways

  • Check the applicable procedure and current implementation guidance before planning a disclosure package.
  • Prepare the public version separately from the complete regulatory submission.
  • Anonymisation requires a reasoned assessment, not simply removal of participant names.

What Does the Publication Package Include?

ElementMeaning
Clinical summariesRelevant overview and summary documents
Clinical study reportsReports within the applicable publication scope
Selected appendicesFor example, protocols and statistical methods

EMA identifies clinical overviews, clinical summaries and clinical study reports, together with specified appendices, within its publication framework. The detailed scope and operational timetable depend on the procedure and current implementation arrangements. Its industry guidance addresses anonymisation reports and the handling of commercially confidential information. Do not reuse a CTIS publication checklist without checking the different scope, submission steps and disclosure requirements. Likewise, do not present the EDPB’s July 2026 consultation version of its anonymisation guidelines as final guidance.

Primary guidance: EMA clinical data publication; EMA industry publication support; EDPB anonymisation consultation.

Why It Matters for Data Protection

For a hypothetical sponsor preparing an oncology report, we recommend reviewing patient narratives, dates, rare characteristics and cross-document links together. Explain why the chosen transformations reduce identification risk while preserving scientific meaning. Keep a record of the assessed audience, available auxiliary information and residual risks. Separate personal-data protection decisions from commercial confidentiality claims: they answer different questions and require different justifications. Assign responsibility for checking the complete package after transformation, including tables and appendices, rather than reviewing each redacted page in isolation.

Frequently Asked Questions

Is Policy 0070 the same as CTIS?

No. They are separate transparency mechanisms with different workflows.

Is deleting names enough?

Not necessarily. Assess whether remaining information can still identify a person.

Is there one deadline for every sponsor?

No. Confirm the current process and timetable for the relevant regulatory procedure.

Related reading: clinical trials information system ctis; EDPB anonymisation guidance and clinical trials.

Explore iliomad’s clinical trials support for your organisation.

Updated: 27 October 2026