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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

Imported item 36

The Common Technical Document (CTD) is an internationally harmonised structure for organising information in applications to register medicines for human use. It arranges the dossier into five modules covering regional information, summaries, quality, nonclinical evidence and clinical evidence. The format standardises organisation; it does not make every regional requirement identical.

Key takeaways

  • The CTD has five modules with distinct functions.
  • Module 1 contains region-specific information.
  • An IMPD and a marketing-authorisation CTD serve different purposes.

What the Five Modules Contain

The ICH M4 organisation guideline sets out the structure. A useful distinction is between where evidence belongs and whether it is sufficient: placing a study report in the right module does not establish that the application meets all substantive requirements.

ModuleContent
1Regional administrative and prescribing information.
2Overviews and summaries.
3Quality documentation.
4Nonclinical study reports.
5Clinical study reports.

Why It Matters for Data Protection

Clinical documentation may contain participant-level information or narratives. As an operational recommendation, review necessity, identifiers, access and disclosure arrangements before submission or later publication. According to ICH’s CTD overview, the eCTD is the electronic implementation of the CTD. Electronic organisation should not be confused with anonymisation, nor should a dossier intended for a regulator be treated as automatically suitable for unrestricted public release.

Hypothetical example: A biotechnology team moves from clinical development towards a marketing-authorisation application. It recommends mapping reusable quality and study information from the trial dossier into the relevant CTD modules, updating the evidence and reviewing personal information separately. The earlier IMPD is an input, not a complete substitute for the registration dossier.

Frequently Asked Questions

Is Module 1 harmonised across every region?

No. It contains region-specific information.

Is the CTD the same as an IMPD?

No. An IMPD supports a clinical trial application; a CTD organises registration information.

Does eCTD mean sending a single PDF?

No. It is an organised electronic submission approach, not simply a document filename or file extension.

Related reading: IMPD, investigational new drug application.

For practical implementation, explore clinical operations and regulatory affairs support.

Updated: 27 October 2026