Clinical research glossary
Terms and acronyms explained clearly — from data management to regulation, including biostatistics and technology solutions.
83 terms shown
ADaM — Analysis Data Model
A CDISC standard that defines the structure of datasets intended for statistical analysis. Built from SDTM data, ADaM datasets are traceable back to the source data and make it possible to reproduce every result in the t…
ALCOA+
A set of principles ensuring data integrity in a clinical trial. A data point must be Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA), and the '+' adds the requirements of completeness, consistency,…
Protocol amendment
A formal change made to a clinical trial protocol after its initial approval. Any substantial amendment must be submitted to the competent authorities and the ethics committee before implementation. It generally results …
Interim analysis
A statistical analysis performed on partial trial data before database lock, at predefined stages set out in the protocol. It makes it possible to assess the treatment's efficacy, safety or futility and may lead to early…
ANSM — French National Agency for Medicines and Health Products Safety
The French competent authority responsible for evaluating and authorizing clinical trials of medicinal products and medical devices. It oversees the safety of health products throughout their life cycle.
Audit trail
An automatic, time-stamped and tamper-proof record of every action performed on a data point in an electronic system: creation, modification and deletion, together with the identity of the author and the reason for the c…
Blinding
A procedure that conceals treatment allocation in order to limit bias. In a single-blind design, the patient does not know which arm they have been assigned to; in a double-blind design, neither the patient nor the inves…
Clinical database
A structured system that centralizes all the data collected during a clinical trial. Built from the eCRF, it is validated, cleaned and then frozen (database lock) before statistical analysis. Its design directly determin…
Biometrics
The discipline that encompasses all the activities related to clinical trial data: data management, biostatistics and statistical programming. Biometrics covers the full cycle, from eCRF design to the production of the a…
Biostatistics / Biostatistician
The discipline that applies statistical methods to the design and analysis of clinical trials. The biostatistician defines the sample size calculation, writes the statistical analysis plan, selects the randomization meth…
Block randomization
A randomization method that allocates patients in successive groups of fixed size in order to balance the number of subjects across the study arms throughout enrollment. It prevents major imbalances in the event of early…
BYOD — Bring Your Own Device
An ePRO data collection approach that allows patients to use their own smartphone or computer, without dedicated hardware provided by the study. BYOD reduces logistical costs and improves compliance, provided that compat…
CDASH — Clinical Data Acquisition Standards Harmonization
A CDISC standard that defines best practices for data collection at the CRF level. CDASH harmonizes the structure of data collection forms and facilitates the subsequent conversion of data to the SDTM format.
CDISC — Clinical Data Interchange Standards Consortium
An international organization that develops the standards for structuring clinical data (CDASH, SDTM, ADaM, define.xml). Adoption of the CDISC standards is required by the FDA and the EMA and ensures data interoperabilit…
CER — Clinical Evaluation Report
A regulatory document that compiles and analyzes the clinical data demonstrating the safety and performance of a medical device. The CER is required by the MDR and must be updated throughout the life of the device, notab…
CPP — French Ethics Committee (Comite de Protection des Personnes)
An independent French body responsible for evaluating the ethics of a research project involving human participants before it begins. The CPP verifies, in particular, the relevance of the protocol, the protection of part…
CRA — Clinical Research Associate
The professional in charge of monitoring investigator sites. The CRA verifies compliance with the protocol and good clinical practice, checks the quality of the data entered in the eCRF and acts as the interface between …
CRF — Case Report Form
A document, either paper or electronic, in which all the data required by the protocol are recorded for each enrolled patient. The electronic version (eCRF) has largely replaced the paper format in modern clinical resear…
Endpoint
A measure defined in the protocol that makes it possible to assess the effect of the treatment under study. The primary endpoint is used to demonstrate the study hypothesis and drives the sample size calculation; seconda…
CRO — Contract Research Organization
A provider that performs all or part of a clinical trial's activities on behalf of a sponsor: clinical operations, data management, biostatistics and regulatory affairs. A full-service CRO covers the entire chain, wherea…
CSR — Clinical Study Report
The final document that presents the methodology, conduct and complete results of a clinical trial. The CSR incorporates the tables, listings and figures produced by the statistical analysis and is a cornerstone of the r…
CTMS — Clinical Trial Management System
Software for the operational management of a clinical trial. The CTMS centralizes the tracking of sites, recruitment, monitoring visits and milestones. It is distinct from the eCRF, which collects patient data, but can i…
Data cleaning
The process of detecting and correcting inconsistencies, missing values or errors in a clinical database. It relies on automated consistency checks and query management, and continues up to database lock.
Clinical data management
All the activities that ensure the collection, control and reliability of clinical trial data. It covers eCRF design, the data management plan, cleaning, medical coding and preparation of the database ahead of analysis.
Data manager
The professional responsible for data quality throughout the trial. They design the eCRF and the consistency checks, drive data cleaning and query management, and prepare the database lock ahead of analysis.
Database lock
The step that definitively locks the clinical database once all the data have been entered, checked and validated. No further change is then possible without a formal procedure. Database lock triggers the start of the st…
DCT — Decentralized Clinical Trial
A trial model in which all or part of the activities take place outside the traditional investigator sites, at the patient's home. Decentralized trials rely on digital tools such as ePRO, eConsent and telemedicine to red…
Define.xml
A metadata file in XML format that describes the structure and content of the SDTM and ADaM datasets. Define.xml is a mandatory component of electronic regulatory submissions and enables reviewers to understand and trace…
DMC / DSMB — Data Monitoring Committee
An independent committee responsible for monitoring participant safety and the conduct of a clinical trial. It reviews interim data, notably during scheduled analyses, and may recommend continuing, modifying or terminati…
DMP — Data Management Plan
A reference document that describes all the data management processes for a trial: eCRF design, consistency checks, query management, medical coding and database lock criteria. The DMP ensures the consistency and traceab…
DPIA — Data Protection Impact Assessment
An assessment required by the GDPR when a data processing operation is likely to result in a high risk to individuals, as is the case for health data. The DPIA identifies the risks and the protective measures put in plac…
eCOA — electronic Clinical Outcome Assessment
A category of digital solutions for capturing clinical outcome measures. eCOA encompasses patient-reported outcomes (ePRO), clinician-reported outcomes (ClinRO), observer-reported outcomes (ObsRO) and performance outcome…
eConsent — Electronic informed consent
The paperless collection of a participant's consent to clinical research. eConsent can incorporate multimedia information materials, verify the patient's understanding and record the signature in a manner compliant with …
eCRF — electronic Case Report Form
The digital version of the case report form, used to enter and manage the data of each patient in a clinical trial. The eCRF incorporates real-time consistency checks and a complete audit trail, and facilitates remote mo…
EDC — Electronic Data Capture
A computerized system for collecting, storing and managing clinical trial data. EDC refers to the overall platform, of which the eCRF is the data entry interface. A compliant EDC meets the requirements of 21 CFR Part 11 …
Edit checks
Automatic rules programmed into the eCRF that detect data entry anomalies in real time: out-of-range values, inconsistencies between fields and missing data. Edit checks reduce the volume of queries and improve data qual…
SAE — Serious Adverse Event
An adverse event that results in death, is life-threatening, requires hospitalization, causes lasting disability or a congenital anomaly. Every SAE is subject to expedited reporting to the authorities as part of pharmaco…
ePRO — electronic Patient-Reported Outcome
The electronic collection, directly by the patient, of data relating to their health status, symptoms or quality of life. ePRO can be completed on a dedicated device or in BYOD mode, online or offline, and improves the r…
Clinical trial
Research conducted on human participants to assess the safety, efficacy or performance of a medicinal product, a medical device or a care strategy. A clinical trial is carried out according to a precise protocol, under t…
Exagis
Axiodis's proprietary technology platform dedicated to the conduct of clinical trials, offered as eCRF, ePRO and reporting modules. Exagis meets the requirements of 21 CFR Part 11 and is hosted on an HDS-certified infras…
FSP — Functional Service Provider
An outsourcing model in which a CRO takes on a specific, ongoing function (data management or biostatistics, for example) on behalf of a sponsor, as opposed to the full delegation of a trial.
Full-service CRO
A CRO able to take on the entire cycle of a clinical trial, from clinical operations to biometrics and regulatory affairs. This model gives the sponsor a single point of contact across the whole project.
GAMP5 — Good Automated Manufacturing Practice
A framework published by ISPE that governs the validation of computerized systems used in regulated healthcare environments. GAMP5 promotes a risk-based approach and classifies software into categories to calibrate the v…
GCP — Good Clinical Practice
An international standard of quality, ethics and science governing the design, conduct and reporting of clinical trials. Defined by the ICH E6 guidelines, good clinical practice protects participants and ensures the reli…
Go-live
The step that brings an eCRF into operational service, authorizing the start of patient data entry. Go-live takes place after system validation and user acceptance testing (UAT).
GxP
A generic term designating all the regulated 'good practices' in the healthcare sector: good clinical practice (GCP), good manufacturing practice (GMP), good laboratory practice (GLP), among others. GxP requirements gove…
HDS — Health Data Hosting (Hebergeur de Donnees de Sante)
A mandatory French certification for hosting personal health data. HDS certification attests that a hosting provider meets strict requirements for security, confidentiality and availability. An eCRF processing patient da…
ICH — International Council for Harmonisation
An international body that develops harmonized guidelines for the development and registration of medicinal products. The ICH guidelines, notably ICH E6 on good clinical practice, are a benchmark in clinical research.
Investigator
The physician or healthcare professional responsible for conducting the clinical trial at a site. The principal investigator coordinates the local team and ensures participant safety and compliance with the protocol. In …
IQ / OQ / PQ — Installation, Operational and Performance Qualification
The successive steps in qualifying a computerized system: IQ verifies correct installation, OQ verifies the proper functioning of the features, and PQ verifies performance under real conditions of use. These steps struct…
ISO 14155
An international standard defining the good clinical practice applicable to clinical investigations of medical devices. It protects participants and ensures the scientific reliability of the data generated.
ITT — Intent-to-treat
An analysis population including all randomized participants, in the arm to which they were assigned, regardless of compliance or protocol deviations. The intent-to-treat analysis preserves the benefits of randomization …
IVDR — In Vitro Diagnostic Regulation
A European regulation (EU 2017/746) governing the placing on the market and surveillance of in vitro diagnostic medical devices. The IVDR strengthened the requirements for clinical evidence and performance of these devic…
IWRS / IRT / RTSM — Interactive randomization system
A computerized system that manages participant randomization and, where applicable, the allocation of treatments and supplies. The IWRS assigns patients to the study arms in a controlled manner and preserves blinding.
Unblinding
A procedure that reveals treatment allocation to the participants of a trial. Unblinding may be planned (at the end of the study, after database lock) or performed on an emergency basis for a patient's safety. It is stri…
Machine learning applied to clinical data
The use of machine learning models to support the quality of a trial's data: automatic anomaly detection, query prioritization and outlier identification. These approaches accelerate data cleaning without replacing human…
MDR — Medical Device Regulation
A European regulation (EU 2017/745) governing the placing on the market and surveillance of medical devices. The MDR strengthened the requirements for clinical evaluation, post-market follow-up and traceability.
MedDRA — Medical Dictionary for Regulatory Activities
A standardized international medical terminology used to code adverse events, medical history and diagnoses in clinical trials. MedDRA is organized into five hierarchical levels, from the most general (SOC) to the most s…
Minimization
A dynamic randomization method that assigns each new participant to the arm that minimizes the imbalance of prognostic factors between the groups. It is useful in small trials involving several stratification factors.
Clinical monitoring
The activity of overseeing a trial to verify compliance with the protocol and good clinical practice, as well as the quality and accuracy of the data. Monitoring can be performed on site, remotely or centrally.
Central monitoring
The remote oversight of a clinical trial, through statistical and cross-sectional analysis of the data collected in the eCRF. Central monitoring identifies atypical sites or data and directs control actions toward high-r…
Multicenter trial
A clinical trial conducted simultaneously at several investigator sites, under a single protocol. The multicenter model accelerates recruitment and strengthens the representativeness of the results, but increases the req…
Part 11 — 21 CFR Part 11
A US FDA regulation that sets out the conditions for the reliability of electronic records and signatures in regulated healthcare environments. Part 11 compliance requires, in particular, an audit trail, access controls …
Pharmacovigilance
The activity of detecting, assessing and preventing the adverse effects of health products. In a clinical trial, pharmacovigilance governs the collection, coding and reporting of adverse events, in particular SAEs.
Phases (I to IV)
The successive stages in the clinical development of a medicinal product. Phase I assesses safety and tolerability in a small group, Phase II preliminary efficacy and dose, Phase III efficacy on a large scale, and Phase …
PMCF — Post-Market Clinical Follow-up
The ongoing collection and analysis of clinical data on a medical device already on the market, in order to confirm its safety and performance over time. PMCF is an MDR obligation and feeds into the update of the clinica…
Sponsor
The natural or legal person who initiates a clinical trial and assumes responsibility for it, including its funding and management. The sponsor may be a pharmaceutical company, a device manufacturer or an academic instit…
Protocol
The reference document that defines the objectives, methodology, inclusion criteria, assessments and statistical plan of a clinical trial. The protocol governs the entire conduct of the study, and any substantial change …
Software qualification
A documented process aimed at demonstrating that a computerized system operates in accordance with its specifications and regulatory requirements. Qualification is structured around the IQ, OQ and PQ steps and forms part…
Query — Data clarification request
A formal request issued when a data point entered in the eCRF appears missing, inconsistent or questionable. The query is sent to the investigator site, which processes it and provides the correction or justification; it…
Randomization
The random assignment of participants to the different arms of a clinical trial. Randomization distributes known and unknown factors evenly across the groups, which limits bias and underpins the validity of the compariso…
RBM — Risk-Based Monitoring
A monitoring approach that focuses control efforts on the sites, processes and data presenting the highest risk to quality and safety. RBM combines central monitoring, risk indicators and targeted visits.
GDPR — General Data Protection Regulation
A European regulation governing the processing of personal data. Health data are treated as sensitive and benefit from enhanced protection, requiring in particular a legal basis, data minimization and, where applicable, …
SAP — Statistical Analysis Plan
A document detailing all the statistical methods planned for analyzing a trial's data: analysis populations, endpoints, models and handling of missing data. The SAP is finalized before database lock in order to ensure th…
SDTM — Study Data Tabulation Model
A CDISC standard defining the structure for organizing the data collected in a clinical trial into standardized domains. The SDTM format is required for regulatory submissions and serves as the foundation for building th…
SDV — Source Data Verification
A check that consists of comparing the data entered in the eCRF against the source documents at the investigator site, in order to confirm their accuracy. In a risk-based approach, SDV is targeted at critical data rather…
Stratification
A technique that distributes randomization within subgroups defined by prognostic factors (site, disease stage, age). Stratification ensures that these factors are balanced between the study arms.
Sample size — Required number of subjects calculation
The determination, before the trial begins, of the number of participants required to demonstrate an expected effect with sufficient statistical power. This calculation depends on the primary endpoint, the expected varia…
TLF / TLG — Tables, Listings, Figures
The set of tables, listings and figures that present the statistical results of a clinical trial. Produced from the ADaM data according to the specifications of the SAP, the TLFs feed into the clinical study report and t…
TMF — Trial Master File
The structured set of essential documents that make it possible to reconstruct and evaluate the conduct of a clinical trial. The TMF, today most often electronic (eTMF), must be complete and available for inspections.
UAT — User Acceptance Testing
A testing phase during which business users verify that an eCRF meets the functional requirements before it goes into production. Successful UAT is a precondition for the study's go-live.
Computerized systems validation
A documented process ensuring that a computerized system, such as an EDC, operates reliably and compliantly throughout its life cycle. Validation follows the risk-based approach defined by GAMP5 and enables compliance wi…
WHODrug — WHO Drug Dictionary
The international reference dictionary for coding medications and concomitant treatments in clinical trials. WHODrug standardizes the analysis of medication data, complementing MedDRA for adverse events.
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