Click here to open the filter panel
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
Click a letter to view all its definitions
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

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.

I

Inspection

An inspection means, in the context of clinical trials, the act by a competent authority of conducting an official review of documents, facilities, records, arrangements for pharmacovigilance and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect (Art. 2(2)(31) EU Clinical Trials Regulation 536/2014).

GCP inspections are conducted by national competent authorities, coordinated by the EMA for centralised applications, and by the FDA worldwide. They may be routine, triggered by a marketing authorisation application, or for cause. Inspectors examine the trial master file, source data, informed consent documentation, computerised systems and audit trails, vendor oversight and safety reporting, and issue findings graded critical, major or minor.

Data protection is now a standard inspection theme: inspectors check that consent forms contain the required GDPR information, that only pseudonymised data reached the sponsor, that data processing agreements and transfer mechanisms exist for vendors, and that access to systems is controlled. Separately, data protection authorities may inspect under Art. 58 GDPR, notified bodies audit medical device manufacturers under the MDR, and market surveillance authorities will inspect under the AI Act. An audit-ready posture, with a current DPIA, register and vendor file, is the most effective preparation. See iliomad's quality assurance services.

Can a GCP inspection happen without a suspected breach?

Yes. GCP inspections may be routine as well as triggered by concerns. Readiness should therefore be part of normal trial management, not an emergency response. Keep essential records retrievable, responsibilities clear and system access workable so the organisation can explain how the trial was conducted and how its data was controlled.