Glossary Terms
Please feel free to
contact us with any questions you may have about terminology not covered below.
Adverse Event
Any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
CDISC
The Clinical Data Interchange Standards Consortium - collection of guidance and standards on how to collect trial data. The FDA’s preferred standard for clinical data submission.
Citrus
Lindus Health’s end to end trial delivery platform.
CRA
Clinical Research Associate - clinical monitor or trial monitor, is a health-care professional who performs many activities related to particularly clinical trials. Name for clinicians on sites who work on clinical research. Part of the Trial Staff.
CRO
Contract Research Organization
CTIMP
(UK usage only) Clinical Trials of Investigational Medicinal Products (
CTIMPS). An investigation in human subjects, other than a non-interventional trial, intended: a) to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, b) to identify any adverse reactions, or c) to study absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products.
CTMS
Clinical trial management system
DCT
Decentralised clinical trials: trials that attempt to ease participation for patients by reducing or eliminating the need to travel to specific study sites.
DiGA
German scheme that allows german health insurers to quickly buy (reimburse) digital health products.
DM
Data manager of a trial.
DTx
Digital Thereputics - a digital product (often a mobile app) that has a measurable therapeutic benefit (like a drug).
eCRF / eCOA
Electronic Case Report Forms/electronic Clinical Outcomes Assessment. Both basically mean the same thing, both are types of electronic form typically filled out by a clinician at a physical site, eg when a patient in a clinical trial comes in to have measurements taken.
EDC
Electronic data capture (any data collection from patients of clinicians) - ePRO, eCOA and eCRFs are types of EDC.
EHR
Electronic health record: The actual health record of a person, available in a digital format (often unstructured as a pdf).
EMR
Electronic medical record: Software systems used by sites/hospitals to keep medical records (distinct from our EDC).
ePRO
Electronic Patient Reported Outcomes. When a patient directly submits data during a study using an EDC like Lime.
eTMF
Electronic Trail Master File: Collection of all information about a trial compiled after the trial is completed. This file should give a 3rd party all the information they need to understand or replicate a trial.
FPI
“First patient in” - the beginning of a trial.
GCP
Good clinical practice: international standards and requirements for how clinical trials should be run.
IRAS
Integrated Research Application System (Unified portal for submitting a trial protocol to MHRA and ethics committees in the UK).
IRB
Institutional Review Board. A US ethics committee that reviews and approves clinical trials.
Lemon
Iteration two of Citrus, enabling multiple concurrent trials.
Lime
Iteration one of Citrus (consisting mostly of EDC).
LMS
Learning Management System (software for training and training records).
Monitoring (in context of clinical trial)
Gathered in a clinical trial is correct and accurate. Traditionally performed manually by CRO ‘Monitors’, at Lindus performed manually and automatically at source by our EDC software.
MRR
Monthly Recurring Revenue
NPS
Net promoter score: a measure of user experience. Ranges from -100 to 100.
OKR
Objectives and key results.
Orange
Iteration three of Citrus.
PI
Principal Investigator, the lead clinician overseeing a clinical trial.
PII
Personally Identifiable Information: anything that can be used to identify a person (name, email address, date of birth, etc.).
Protocol
Highly detailed description of all aspects of how a trial will be run.
QMS
Quality management system.
SAE
Serious Adverse Event.
SLDC
Software Development Lifecycle
SOP
Standard operating procedure; documentation for any process.
STM
Senior trial manager.
SUSAR
Suspected Unexpected Serious Adverse Reaction: classification of SAEs.
Therapeutic Area
Clinical trials have different requirements and processes depending on the are being investigated e.g. Diabetes, Mental Health, Cardiology.
TMF
Trial Master File: non electronic version of eTMF.
TN
Trial nurse - medically trained person who conducts screening calls and can be clinician or a regular trial site nurse.
TS
Trial staff - includes most trial roles including clinicians, nurses, trial manager, data manager.
UAT
User Acceptance Testing: type of testing performed by the client (sponsor) to verify/accept the software system before moving the software application to the production environment.
UI
User interface.
Unanticipated adverse device effect
Any serious effect on health and safety caused by a device being used in a clinical trial (usually the device being investigated).
UX
User experience.
Validation
(Different from Monitoring!) Validating technology or processes used in clinical trials, eg whether a particular form has been reproduced correctly in an EDC or whether a piece of technology meets regulatory standards.
