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R
Randomised clinical trial (RCT)
R
Real-world data (RWD)
R
Real-world evidence (RWE)
R
Recipient
R
Record of processing activities (RoPA)
R
Regulatory intelligence
R
Re-identification risk (motivated intruder test)
R
Restriction of processing
R
Right not to be subject to solely automated decision-making
R
Right of access
R
Right of information
R
Right of rectification
R
Rights of the data subject
R
Right to data portability
R
Right to erasure ("right to be forgotten")
R
Right to object
R
Right to restriction of processing
S
Schrems II
S
Scientific research purposes (Art. 89 GDPR)
S
Secondary use of health data
S
Security breach (security incident)
S
Security of processing
S
Sensitive data
S
Serious adverse event (SAE)
S
Shadow AI
S
Site management organisation (SMO)
S
SNDS (Système National des Données de Santé)
S
Software as a Medical Device (SaMD)
S
Source data verification (SDV) and source documents
S
Special categories of personal data
S
Sponsor
S
Standard contractual clauses (SCC)
S
Start of a clinical trial
S
Storage limitation (limited storage periods)
S
Study Data Tabulation Model (SDTM)
S
Subject (clinical trial participant)
S
Sub-processor
S
Supervisory authority
S
Supplementary measures
S
Swiss Federal Act on Data Protection (FADP / revFADP)
S
Swissmedic
S
Synthetic data
T
Technical and organisational measures (TOMs)
T
Temporary halt of a clinical trial
T
Third country
T
Third party
T
Transfer impact assessment (TIA)
T
Trial master file (TMF)
T
Trusted research environment (TRE)
U
UK GDPR
U
Unexpected serious adverse reaction (SUSAR)
U
US CLOUD Act
V
Validation (computerised system validation, CSV)
V
Vendor assessment (third-party risk management)
V
Vital interests (Art. 6(1)(d) GDPR)
V
Vulnerable participants (vulnerable subjects)
W
Wearables and digital health technologies (DHT)
W
Withdrawal (of consent and from a clinical trial)
W
World Health Organization (WHO)
X
XAI (explainable artificial intelligence)
Y
Yellow Card scheme (UK)
Z
Zero-knowledge proof
Z
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.

R

Right to object

The right to object is the right of the data subject to object, on grounds relating to his or her particular situation, at any time to processing of personal data concerning him or her which is based on the public interest or official authority (Art. 6(1)(e)) or on legitimate interests (Art. 6(1)(f)), including profiling based on those provisions. The controller must then stop processing unless it demonstrates compelling legitimate grounds which override the interests, rights and freedoms of the data subject, or the processing is needed for legal claims (Art. 21(1) GDPR).

Where personal data are processed for direct marketing, the right to object is absolute: processing for that purpose must cease on objection, without any balancing (Art. 21(2) and (3)). The right must be explicitly brought to the attention of the data subject at the latest at the time of the first communication, clearly and separately from other information (Art. 21(4)), and may be exercised by automated means in the context of information society services (Art. 21(5)).

Art. 21(6) contains a research-specific rule: where personal data are processed for scientific or historical research or statistical purposes, the data subject may object on grounds relating to their particular situation, unless the processing is necessary for the performance of a task carried out for reasons of public interest. Member State law implementing Art. 89(2) may further limit the right where it would seriously impair the research. For sponsors relying on legitimate interest for trial data or on secondary use of health records, this means that an objection procedure must exist, that compelling grounds (data integrity, patient safety, regulatory obligations) must be assessed and documented case by case, and that the informed consent form or notice must mention the right. Objections to pharmacovigilance processing, which rests on legal obligation, are not available.

Can a person always stop any processing by objecting?

No. The right to object depends on the purpose and legal basis, and some objections require a case-specific assessment. Direct-marketing objections are different: processing for that purpose must stop. Identify the activity concerned and assess the applicable rule, rather than assuming an objection either cancels every use or can always be refused.