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Randomised clinical trial (RCT)
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Zero trust architecture
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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.

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21 CFR Part 11

21 CFR Part 11 is the US FDA regulation setting criteria for electronic records and electronic signatures to be considered trustworthy, reliable and equivalent to paper records and handwritten signatures. It applies within its defined FDA-regulated scope, not automatically to every system that stores healthcare or research information.

Key takeaways

  • Applicability depends on the records and underlying FDA requirements.
  • Controls address records, system access and electronic signatures.
  • EU GMP Annex 11 is related but not a universal equivalent.

Which Records and Controls Are Covered?

The regulation covers relevant electronic records required by FDA rules and certain electronic submissions. Its closed-system controls include validation, access restrictions and secure, time-stamped audit trails. The FDA scope guidance describes a narrower interpretation and enforcement discretion for specified provisions; it does not abolish underlying recordkeeping obligations or make unreliable records acceptable.

Control areaOperational purpose
ValidationDemonstrate reliable intended performance.
Audit trailRecord relevant creation and changes.
Signature controlsLink authorised signers to signed records.

Why It Matters for Data Protection

Part 11 supports record integrity but is not a general privacy law. As an operational recommendation, review user permissions, exports and retention alongside applicable data protection requirements. EU GMP Annex 11 concerns computerised systems used in GMP activities; it should not be presented as the rule governing every European clinical system. Determine both regulatory scope and actual system use before writing a compliance statement.

Hypothetical example: A sponsor selects an electronic data capture platform. Rather than accepting a vendor’s generic ‘Part 11 compliant’ label, the team recommends testing its configured roles, signature workflow and audit-trail retrieval against the records it will maintain.

Frequently Asked Questions

Does every spreadsheet fall under Part 11?

No. Its role in maintaining required records and the applicable scope must be assessed.

Is validation a vendor certificate?

No. Supplier evidence can help, but intended use and configured operation need assessment.

Does Part 11 compliance establish GDPR compliance?

No. Record integrity controls do not resolve lawful processing, transparency or international transfers.

Related reading: computerised system validation, electronic data capture.

For practical implementation, explore quality assurance support.

Updated: 27 October 2026