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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

CPRD (Clinical Practice Research Datalink)

Clinical Practice Research Datalink (CPRD) is the MHRA’s real-world data research service, supporting public health and clinical studies using routinely collected health information. It developed from the General Practice Research Database (GPRD). Its data resources include primary care records and linked datasets, accessed through defined governance arrangements rather than unrestricted reuse.

Key takeaways

  • CPRD supports research using routinely recorded healthcare data.
  • Approved access requires governance and licensing arrangements.
  • Pseudonymised collection and anonymised research releases are distinct.

Which Data and Permissions Are Involved?

The history of CPRD explains its GPRD origins. Its study approval process assesses proposed research use. As an operational recommendation, check dataset suitability, population coverage, linkage availability and the approved protocol before committing to an analysis. A familiar dataset name does not establish that every required variable or follow-up period is available.

Resource or stageMeaning
Primary care recordsCoded consultations, diagnoses, measurements and prescriptions.
Linked recordsAdditional information, such as hospital or cancer registry data.
Study approvalReview of the proposed use before authorised access.

Why It Matters for Data Protection

The CPRD patient privacy notice distinguishes pseudonymised records received by CPRD from anonymised data released for approved research. It sets out UK GDPR bases for CPRD’s own processing. Those bases are not a universal permission for another organisation’s independent data collection or linkage. As an operational recommendation, document the precise access model and assessing any additional information brought into the project.

Hypothetical example: A sponsor plans an observational safety study using primary care and linked hospital data. Its team recommends aligning the cohort, outcomes and linkage needs with the approved protocol, while checking that imported reference files do not contain prohibited personal information.

Frequently Asked Questions

Is CPRD the old GPRD?

CPRD developed from GPRD, but its present service and resources are broader.

Do researchers receive patients’ names?

CPRD describes its approved research releases as anonymised, not direct-identifier exports.

Does coding automatically remove UK GDPR obligations?

No. CPRD’s own notice distinguishes pseudonymised processing from anonymised research releases.

Related reading: real-world data, secondary use of health data.

For practical implementation, explore clinical research support.

Updated: 27 October 2026