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Clinical trial systems glossary
Key terms used to describe clinical trial system architectures, data management concepts, and operational entities.
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1 term- 21 CFR Part 11
- A U.S. Food and Drug Administration (FDA) regulation that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
A
3 terms- Adverse Event AE
- Any unfavorable and unintended medical occurrence in a patient or subject during a clinical trial.
- ALCOA+ Principles
- Data integrity principles ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
- Audit trail
- A secure, timestamped record that captures all relevant user actions and data changes within a system. In a unified platform, the audit trail spans all functional activity within a single system.
C
5 terms- Centralized audit trail
- An audit trail architecture in which all user actions across clinical, operational, and oversight functions are recorded in one continuous, system-wide log rather than separated by application.
- Clinical Data Management CDM
- The process of collecting, cleaning, validating, and managing clinical trial data to ensure accuracy, completeness, and regulatory compliance.
- Clinical Trial Management System CTMS
- A system used to manage operational aspects of clinical trials, including site information, milestones, timelines, monitoring activities, and study progress tracking.
- Common data platform
- A centralized system architecture in which clinical, operational, and regulatory data are stored, managed, and accessed within a shared environment using a unified data model. It enables consistent data governance, eliminates duplication, and supports real-time data availability across all trial functions.
- Contract Research Organization CRO
- A service provider that manages clinical trial operations and services on behalf of the sponsor.
D
10 terms- Data flow
- The mechanism by which data is transferred or made available between systems or processes. In traditional stacks, data flow relies on ETL or integrations; in unified platforms, data is available in real time within a single system.
- Data lineage
- Documented history of a data element, including its origin, transformations, and usage throughout the clinical trial lifecycle. Clear data lineage supports traceability and regulatory inspection requirements.
- Data ownership
- Assignment of authority and responsibility for creating, maintaining, and governing specific data entities within a clinical trial system. In fragmented systems, ownership is distributed across applications; in unified platforms, ownership is centralized.
- Data quality
- The degree to which clinical trial data is accurate, complete, consistent, timely, and fit for its intended use, including analysis, reporting, and regulatory submission. Data quality is influenced by how data is captured, validated, stored, and maintained throughout the trial lifecycle.
- Data reconciliation
- The process of comparing, aligning, and resolving discrepancies between data records stored in different systems. Reconciliation is typically required in fragmented or integrated system landscapes.
- Data silos
- Isolation of clinical, operational, and regulatory data across separate systems or teams, preventing holistic visibility, cross-functional collaboration, and efficient data reuse.
- Data standardization
- Organizing and formatting clinical trial data according to Clinical Data Interchange Standards Consortium (CDISC) standards to ensure consistency, interoperability, and regulatory acceptability.
- Data validation
- The process of reviewing clinical trial data to ensure accuracy, completeness, consistency, and compliance with protocol-defined rules and regulatory standards.
- Database lock DBL
- The point in a clinical trial at which the clinical database is finalized and no further changes to data are permitted prior to analysis and regulatory submission.
- Decentralized clinical trials DCTs
- Clinical trials that leverage digital technologies and remote processes to conduct study activities outside traditional investigator sites, including eConsent, ePRO, telemedicine, and eSource.
E
8 terms- Electronic Data Capture EDC
- A system used to electronically collect, manage, and store clinical trial data.
- Electronic Informed Consent eConsent
- A digital process for presenting study information and obtaining participant consent electronically.
- Electronic Patient-Reported Outcomes ePRO
- Digital collection of health outcome data directly reported by patients.
- Electronic Source Data eSource
- Clinical trial source data that is captured electronically at the point of origin.
- Electronic Trial Master File eTMF
- A digital system for managing essential clinical trial documents in compliance with regulatory requirements.
- Endpoint
- A predefined outcome used to evaluate the effect of a medical intervention. Endpoints may be primary or secondary depending on their role in the study design.
- External clinical tools
- Supplementary systems used alongside core trial platforms, such as tools for monitoring, analytics, reporting, or patient-reported outcomes. These systems often operate outside the primary system architecture.
- Extract, Transform, Load ETL
- A data integration process in which data is extracted from one system, transformed to match required formats or rules, and loaded into another system. ETL is commonly used in traditional clinical trial stacks to synchronize data across systems.
F
2 terms- FDA
- The U.S. Food and Drug Administration is a federal regulatory authority responsible for protecting public health by overseeing the safety, efficacy, and quality of drugs, biologics, medical devices, and related products.
- Fragmented clinical trial systems
- A system landscape composed of multiple independent applications, each managing a specific function and maintaining its own database, data model, validation logic, and audit trail. Fragmentation leads to duplicate data, synchronization dependencies, and reconciliation effort.
G
2 terms- GDPR
- The General Data Protection Regulation is an EU regulation that governs the collection, processing, storage, and protection of personal data for individuals within the European Union. In clinical trials, GDPR establishes requirements for lawful data processing, access control, data minimization, and accountability, influencing how subject-related data is handled across clinical data platforms.
- GxP compliance
- Adherence to Good Practice (GxP) regulations and guidelines that govern processes, systems, and controls used in regulated activities such as clinical trials. In the context of clinical data platforms, GxP compliance ensures that electronic systems (e.g., EDC, CTMS, eTMF) maintain data integrity, traceability, security, and auditability, so that data is reliable, reproducible, and acceptable for regulatory review throughout the trial lifecycle.
H
1 term- High integration costs
- Significant costs and effort required to build, maintain, and validate system integrations in fragmented clinical trial environments.
I
6 terms- ICH-GCP
- An international ethical and scientific quality standard that defines requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. ICH-GCP aims to ensure the rights, safety, and well-being of trial participants while maintaining the credibility and integrity of clinical trial data.
- Informed Consent IC / ICF
- A process by which a participant voluntarily confirms willingness to participate in a clinical trial after being informed of all relevant aspects.
- Integrated systems
- A collection of independent clinical trial systems connected through interfaces or APIs to exchange data. While integration enables communication between systems, each application remains a separate system of record with its own database and audit trail.
- Integration breakpoints
- Failures or data inconsistencies caused by fragile or custom-built system integrations in multi-system clinical trial environments.
- Interoperability
- The ability of systems, applications, or modules to exchange and use data seamlessly.
- Investigator site
- A clinical location where trial-related activities are conducted under the supervision of an investigator.
M
4 terms- Master data
- Core reference data, such as subjects, sites, studies, and visits, that is reused across multiple trial functions and requires consistent ownership and governance.
- Metadata
- Structured information that describes, explains, or contextualizes clinical data, making it easier to identify, manage, and use correctly. In clinical trial systems (such as EDC, CTMS, and eTMF), metadata includes details like data definitions, variable names, formats, timestamps, authorship, version history, and relationships between data elements.
- Modular eClinical systems
- An eClinical architecture composed of separate, function-specific systems (such as EDC, eTMF, ePRO, and safety) that are implemented independently and integrated through interfaces or data exchanges.
- Monitoring
- Ongoing oversight of a clinical trial conducted by the sponsor or delegated party to ensure that the study is performed in accordance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements, and that participant safety, data integrity, and study quality are maintained.
O
1 term- Oversight
- The ability to monitor, review, and control trial activities and data across clinical, operational, and compliance domains. Oversight is typically fragmented across systems in traditional stacks and centralized in unified platforms.
P
2 terms- Patient recruitment
- The process of identifying, screening, and enrolling eligible participants into a clinical trial.
- Protocol deviation PD
- A departure from the approved study protocol requirements.
R
7 terms- Randomization
- Assignment of participants to treatment groups using a random process to reduce bias.
- Randomization and Trial Supply Management RTSM
- A clinical trial system responsible for subject randomization, treatment assignment, and management of investigational product supply across sites.
- Real-time data availability
- The capability for data changes to become immediately visible across all relevant functions without delay or synchronization processes. Real-time availability is a defining characteristic of unified platforms.
- Real-time data processing
- Immediate availability and processing of data across systems without latency.
- Referential integrity
- An assurance that relationships between related data records remain valid and consistent across the system, such as links between subjects, visits, and events.
- Regulatory compliance
- Adherence to applicable laws, regulations, guidelines, and standards governing clinical trials, ensuring that trial activities, data, and documentation meet requirements set by regulatory authorities (such as FDA, EMA, and ICH) to protect participant safety, maintain data integrity, and support inspection and approval processes.
- Role-based access control
- A permission model that restricts system access based on user roles, ensuring users can only view or modify data appropriate to their responsibilities.
S
7 terms- Safety system
- A system used to collect, manage, and report adverse events and safety data generated during a clinical trial, supporting pharmacovigilance and regulatory reporting requirements.
- Serious Adverse Event SAE
- Per ICH E2A, an adverse event that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in a congenital anomaly or birth defect, or is another medically important event.
- Shared data model
- A unified representation of clinical and operational entities, such as subjects, sites, visits, and events, used consistently across all system functions. A shared data model ensures that entities exist once and are referenced uniformly.
- Single database model
- An architectural design in which all clinical trial functions share one central database. Data changes are recorded once and become immediately available across all functional modules without synchronization or duplication.
- Source Data Verification SDV
- Verification of clinical trial data against original source records.
- Study protocol
- A formal document describing study objectives, design, methodology, statistical considerations, and operational conduct.
- System of record
- The authoritative source system in which a specific data entity is created, maintained, and governed. In unified platforms, a single system of record exists for all core trial entities.
T
1 term- Traditional clinical trial technology stack
- A commonly used configuration consisting of multiple specialized systems, such as EDC, CTMS, RTSM, and eTMF, linked through integrations. Functional responsibilities are distributed, but data ownership and oversight are separated across systems.
U
1 term- Unified clinical trial platform
- A clinical trial system architecture in which all clinical, operational, and oversight functions operate on a single shared database and data model. Data entities are created once, governed centrally, and audited within one system rather than synchronized across multiple independent tools.
V
2 terms- Validation
- The process of establishing documented evidence that a system performs as intended and maintains data integrity in accordance with regulatory requirements. In fragmented systems, validation is performed per system; in unified platforms, validation applies across functions.
- Vendor approaches
- General categories used to describe clinical trial system providers, including point solution vendors, integrated system suites, and unified platform vendors. These terms describe architectural approaches rather than feature scope.
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