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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.

D

Data subject access request (DSAR)

A data subject access request (DSAR), often simply "access request" or "SAR", is a request by a data subject to exercise the right of access under Art. 15 GDPR (or Art. 15 UK GDPR, Art. 25 Swiss FADP). The term is also used loosely for any request to exercise data subject rights. Requests may be made in any form, orally or in writing, to any part of the organisation, and need not use legal terminology; staff training to recognise them is therefore essential.

A compliant DSAR procedure covers: logging the request and the date of receipt; verifying identity proportionately, without demanding more information than necessary; clarifying the scope where the volume of data is large (the EDPB Guidelines 01/2022 allow this but the default is all data); searching all systems including emails, backups within reason and processors' systems; reviewing for third-party data and exemptions (legal privilege, trade secrets, rights of others under Art. 15(4)); and responding within one month, extendable by two months for complex or numerous requests with notice to the requester (Art. 12(3)). The response must include the personal data in an intelligible form, the Art. 15(1) information (purposes, categories, recipients, retention, source, automated decision-making), and be free of charge unless manifestly unfounded or excessive. Refusals must be reasoned and mention the right to complain to a supervisory authority.

In clinical research, a participant's DSAR is usually received by the investigator site, which holds identifying records; the sponsor holds only pseudonymised data and cannot link it to the requester without the site's key. A joint procedure between sponsor, site and CRO defines who responds, how the sponsor's data is retrieved via the subject number, and how research derogations under Art. 89(2) and national law are applied where access would seriously impair the research (for instance disclosure of treatment allocation in a blinded trial). Site staff, employees and healthcare professionals in CRM databases are other frequent requesters. A well-run DSAR process is also a diagnostic tool: difficulty in locating data usually reveals gaps in the record of processing activities.