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Explicit consent
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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.

S

Site management organisation (SMO)

A site management organisation (SMO) is a service organisation that supports the operation of clinical research sites. Depending on its agreement, support may include study coordination, administration and site resources. The label describes an operating model, not a transfer of all investigator responsibilities or an automatic data-protection role.

Key takeaways

  • An SMO typically supports site operations, while a CRO may perform a broader range of activities transferred by a trial sponsor.
  • ICH E6(R3) preserves investigator responsibility for activities under the investigator’s remit, even when a service provider performs those activities.
  • Data-protection roles should reflect actual decisions and processing arrangements, not the commercial label SMO or the presence of a services contract.

SMO and CRO Compared

OrganisationTypical focus
SMOSupport for the investigator and site operations
CROSponsor-contracted trial activities, potentially across multiple sites
InvestigatorOversight of trial conduct within the investigator’s responsibilities

ICH E6(R3) uses the broader term service provider and emphasises documented responsibilities and oversight. An SMO’s scope should therefore be read alongside the site agreement, delegation records and actual operating arrangements, rather than inferred from its name.

For example, consider a hypothetical SMO coordinator scheduling visits and entering data for a hospital investigator. Before granting access, define the permitted tasks, training, supervision, systems and escalation route. A coordinator’s administrative involvement should not be confused with independent authority to make clinical decisions.

Why It Matters for Data Protection

Operationally, map whether SMO staff use hospital systems, sponsor platforms or their own environment. Record who can access identifiable records, who receives coded exports and whether any information is reused for another purpose.

We recommend reviewing privacy roles for each activity, then aligning contracts, access controls and participant information. Include staff departures and study closure: an outsourced coordinator’s account should not remain active simply because the organisation supports other studies.

Frequently Asked Questions

Is an SMO the same as a trial site?

No. It may support a site, operate a network or provide staff; examine the actual arrangement.

Does outsourcing remove investigator oversight?

No. ICH E6(R3) retains responsibility for activities under the investigator’s remit.

Is every SMO a processor?

No. The role requires an assessment of the actual processing and decision-making.

Related: clinical trial sites; CROs; clinical service-provider support.

Updated: 27 October 2026