AABB, AADA, AAMC, AAPS, AAS, abbreviation, ABPI, absorption, accelerated approval, ACCP, accrual, ACDM, ACE, ACIL, ACPU, ACRA, acronym, ACRP, ACT, ACTG, action letter, activation (EDC), active ingredient, active ingredient dose, active substance, ACTU, ADaM, adaptive design, additive effect, additive effect, ADE, adequate and well-controlled studies, adherence, adherence, adjuvant therapy, ADME, administrable dosage form, administration (substance), administrative claims data, admission criteria, ADR, adverse drug reaction (ADR), adverse event, adverse event (AE), adverse event of special interest, adverse reaction, adverse reaction, AE, AEGIS, AEGIS (ADROIT Electronically Generated Information Service), AERS, AFMR, AHA, AHCPR, AHIC, AHIC (American Health Information Community), AI, AI prompt, AICRC, AIDS, ALCOA, ALCOA, ALCOA+, ALCOA++, alert, algorithm, alpha error, am, AMA, AMC, amendment, American National Standards Institute (ANSI), AmFAR, AMG, AMP, AMWA, analysis, analysis dataset, analysis set, analysis variables, analyze, anchor, ANDA, anonymization, anonymize, ANOVA, ANSI, antagonistic effect, antibody, antibody, anticipated adverse event, antigen, antigen, AOAC, APB, APhA, API, APPI, applet, applicable regulatory requirement(s), approvable letter, approval (in relation to Institutional Review Boards), approval letter, ARCS, arm, ARO, artificial intelligence (AI), ASAP, ASCII, ASCPT, ASP, ASQ, assent, assent form, assent form, assessment, assessment, ATC, attributable, attribute (n), AUC, audit, audit certificate, audit report, audit trail, authorised auxiliary medicinal product, authorised investigational medicinal product, authorization, autoimmunity, auxiliary medicinal product, AxMP, back translation (natural language), background material, background treatment, balanced study, bandwidth, BARQA, baseline assessment, baseline assessment, baseline characteristics, baseline imbalance, basket trial, basket trial, basket trial design, Bayesian approaches, Bayesian statistics, BCE, BDPA, benefit summary, benefits of a research study, BEST, beta error, BEUC, BfArM, BGA, BGVV, bias, bias, BID, BIO, bioanalytical assays, bioavailability, biobanking, bioequivalence, biological product, Biologics licensing application (BLA), biomarker, biomarker, biometric signature, biorepository, biosimilar, biospecimen, biostatistics, BIRA, birth control, BLA, blind review, blinded (masked) medications, blinded study, blinding, blood draw, blood draw, branch, BrAP, BRIDG, browser, BSA.


C3C, CA, caBIG, cache, caCORE, caDSR, carry-over effect, CAS, case history, case report form (CRF), case report tabulations (CRT), case-control study, categorical data, causal effect, causal inference, causality assessment, CBER, CBIIT, CCPPRB, CCRA, CCRC, CCRP, CCSI, CDA, CDASH, CDC, CDE, CDER, CDISC, CDISC Library, CDISC standards, CDM, CDMS, CDRH, cell therapy, CEN, certified copy, certified IRB professional (CIP), CEU, CF, CFR, cGMP, challenge agent, CHI, CHI (consolidated health informatics), CHR, CIC, CIOMS, CIP, CIS, class, clean database, clean file, CLIA, client, clinical benefit, clinical benefit, clinical clarification, clinical data, clinical development plan, clinical document, clinical document architecture, clinical efficacy, clinical encounter, clinical hold (of a clinical trial), clinical investigation, clinical outcome assessment (COA), clinical outcome assessment (COA) qualification, clinical pharmacology, clinical research, clinical research and development, clinical research associate (CRA), Clinical Research Coordinator (CRC), clinical research coordinator (CRC), clinical research subject, clinical significance, clinical study, clinical study data element, clinical study report, clinical trial, clinical trial, clinical trial authorization, clinical trial data, clinical trial exemption (CTX), clinical trial information, clinical trial materials, clinical trial registry, clinical trial results registry, clinician, clinician-reported outcome (ClinRO), ClinRO, cluster randomized trial, Cmax, CMC, CME, CMS, CNS, co-packaged product, COA, codelist, coding, cognitive debriefing, cohort, cohort, cohort study, combination product, commercially confidential information (CCI), common data element, common data element (CDE), common data model (CDM), Common Technical Document, Comparative Effectiveness Research (CER), Comparative Effectiveness Research (CER), comparative study, comparator, comparator (product), compendial name, compensation, Competent Authority (CA), compliance, compliance (in relation to trials), computable phenotype, computer application, Computerized Tomography (CT) scan, concept, concept of interest, concerned member state (CMS), concomitant medication, concomitant medications, conduct, conduct, confidence interval, confidence interval (CI), confidentiality, confidentiality, confirmatory trial, conformity assessment, confounding, confounding variable, consent form, consent form, CONSORT, construct validation (COA), consumer safety officer (CSO), content validation (COA), content validity, context of use, contingent subject trial contact, continuity of coverage, contract, Contract Research Organization (CRO), contract research organization (CRO), contraindicated, control, control group, control group, control of electronic records, controlled study, controlled vocabulary, coordinating committee, coordinating investigator, COP, CORE, correlation, correlation, COSTART, COU, covariate (prognostic), COVID-19, CPHS, CPMP, CPSC, CR, CRA, CRADA, CRB, CRC, CRF, CRF (paper), CRF data, criterion validation (COA), CRIX, CRO, cross-labeled product, cross-sectional study, crossover trial, CRT, CSDD, CSF, CSM, CSO, CSR, CSU, CSUICI, CT, CTA, CTC, CTCAE, CTCAE (Common Terminology Criterion for Adverse Events), CTD, CTEP, CTM, CTX, CUI, CUI (common unique identifier), curriculum vitae (CV), CV, CVM, cybersecurity, data, data, data acquisition, data capture, data clarification, data clarification form, data coding, data collection, data collection instruments, data controller, data curation, data element, data element identifier, data encryption standard (DES), data entry, data harmonization, data imputation, data integrity, data integrity verification, data interchange, data item, data lake, data listing, data management, data management conventions, data minimization, data model, data monitoring, data monitoring committee (DMC), Data Monitoring Committee (DMC/DSMB), data origin, data originator, data processor, data quality, data security, data selection criteria, data sharing, data standards, data storage, data subject, data transformation, data transformations, data type, data validation, data warehouse, database, database, database lock, dataset, date of first enrollment, DAWN, DCGI, DD, DDF, DDI, DDT, de-identification, de-identification, de-identified information, DEA, decentralized clinical trial (DCT), decision rule, Declaration of Helsinki, deep learning, Define-XML, demographic data, DEN, dependent variable, deployment, derived variable, DES, DESI, design configuration, development plan, DGPharMed, DHHS, DHTML, DIA, diagnose, diagnostic device, DIBD, DIBD (development international birth date), DICOM, digital signature, DIMs, direct access, direct entry, direct identifier, discontinuation, discontinue, discrepancy, disease, disease progression, disease-free survival, disease-free survival, dissent, distributed data network, DITA, DLT, DMB, DNA, document (HL7), document root, document type definition (DTD), documentation, domain, domain name, dosage, dosage form, dosage regimen, dose, dose escalation, dose strength, dose-escalation trial, double-blind study, double-blind study, double-dummy, DPC-PTR, DRE, dropout, drug, drug development process, drug distribution, drug holiday, drug interaction, drug product, drug therapy, drug treatment, DSI, DSM, DSMB, DSMC, DSNP, DST, DSUR, DTC, DTD, dynamic HTML.


e-consent, E3C, EAB, Early Phase I, early termination of trial, EC, EC50, eCertified copy, ECG, ECJ, eClinical trial, eCOA, ECOG, eConsent form, ECPHIN, eCRF, eCRF (electronic case report form), ECRIN, eCRT (electronic case report tabulation), eCTD, EDC, EDC (electronic data capture), EDI, edit check, eDMS, EDR, EDR (electronic document room), eDT, EEC, effect size, effectiveness, effectiveness, efficacy, efficacy, EFGCP, EFPIA, EFTA, eHR, EHR (electronic health record), EIR, ELA, electronic data transfer, Electronic Health Record (EHR), electronic personal health record (ePHR), electronic record, electronic signature, eligibility criteria, eligibility criteria, EMA, EMEA, emergency use authorization, Emergency Use Authorization (EUA), EMR (electronic medical record), EMWA, end-point assessment medicinal product, endemic disease, endpoint, endpoint, enroll, enrolled, enrollment, enrollment (cumulative), enrollment (current), EOP2A, EORTC, EP, EPAR, epidemic, EPO, epoch, EPRG, ePRO, ePRO, equipoise, equivalence, equivalence trial, equivalent effect, ER, ERSR, eRX, eSDI, ESG, eSource, eSource data, eSource document, eSR, ESRA, eSRF, eSRF (electronic source report form), essential documents, established name, estimand, ESTRI, ethics committee, ethnicity, EU, EU CTR, EUA, EUDRA, EudraCT, European Medicines Agency (EMA), evaluable (for efficacy and safety), evaluate, event, EVS, EWG, exclusion criteria, exclusion criteria, excretion, expanded access, expansion cohort trial, experimental, experimental intervention, experimental unit, exploratory IND study, exploratory objective, exploratory research, exploratory study, exposure, exposure (individual), eXtensible markup language (XML) data element, extent of exposure, extraction transformation load (ETL), FAERS, FAQ, Farmindustria, FD&C Act, FDA, FDAA, FDAMA, FDLI, feels, FFPM, FHIR, field, File Transfer Protocol (FTP), final report, finding, FIPS, first subject in - date, first subject in - identity (FSI - identity), first subject screened - date, first subject screened - identity, first subject treated - date, first subject treated - identity, first-in-humans study, FISMA, focus group, follow-up (clinical study), Food and Drug Administration (FDA), Form, FRCP, frequency, frequentist methods, frozen, FTC, FTP, functional roles (in a study), functions, FWA.


GBP, Gbps, GCP, GCRP, GDPR, gender, gene therapy, general observation class, generalizability, generalizability, Generative AI (GenAI), generic name, genetic testing, global assessment variable, glossary, GLP, GMP, GMT, Good Clinical Practice (GCP), GP, GPMS, GPT, GPVP, granularity, GRAS, group sequential design, GRP, GXP, HA, handwritten signature, harmonized standard, hazard ratio, hazard ratio, HD, Health Level 7 (HL7), health literacy, health-related quality of life (HRQoL), healthcare facility, healthcare provider, healthy volunteer, healthy volunteer, HEOR, hereditary, hereditary, HEX, HHS, HIE, HIE (Health Information Exchange), HIMA, HIMSS, HIPA, HIT, HITSP, HL7, HPB, HPLC, HRQoL, HSRC, HTML, HTTP, human subject, Huriet Law, hypertext, HyperText Markup Language (HTML), hypothesis, hypothesis to test.


I3C, IB, IBD, IC, ICD, ICF, ICG, ICH, ICMJE, ICR, ICSR, ICTH, ICTRP, ICU, IDE, IEC, IEEEE, IFAP, IFPMA, IG, IHE, IHI, IKS, IMI, immediately life-threatening disease or condition, immortal time, immune response, immune system, IMP, impartial witness, IMPD, in vitro diagnostic device, incentive, incidence, incidence, incidence rate, inclusion criteria, inclusion criteria, IND, independent data monitoring committee (IDMC), independent ethics committee (IEC), independent variable, indication, indirect identifier, informed consent, informed consent, infusion, infusion, ingredient, INN, inspection, Institutional Review Board (IRB), institutional review board (IRB), instrument, intended use, intention-to-treat, inter-rater reliability, intercurrent event, interim analysis schedule, interim analysis(es), interim clinical trial/study report, intermittent, internal consistency, international birth date (IBD), international nonproprietary name (INN), internet, internet service provider (ISP), interoperability, intervention, interventional study, investigational device, Investigational Device Exemption (IDE), investigational medicinal product, investigational medicine, Investigational New Drug (IND), Investigational New Drug (IND) application, investigational product, investigational product code, investigator, investigator, investigator's brochure, investigator/institution, IOM, IRB, IRD, IS, ISCB, ISDN, ISO, ISOQOL, ISP, IT, item, item (PRO), item definition, item generation, item group definition, ITU-T, IUPAC, IVD, IVRS, J3C, Janus conceptual model, Janus study data repository, JCAHO, JCG, JMA, JPMA.


KASA, Kbps, KFDA, LAB, label, labeling (content of), laboratory (clinical), LAN, LAR, Large Language Model (LLM), last subject in - date, last subject in - identity (LSI - identity), last subject last visit - date, last subject last visit - identity (LSLV - identity), legal authentication, legally acceptable representative, LIF, life-threatening adverse event/ experience, LKP, LLM, LOA, LOINC, long term follow-up (clinical study), longitudinal study, longitudinal study, low-interventional clinical trial, LREC.


MA, MAA, machine learning, Magnetic Resonance Imaging (MRI), MAH, manufacturer (device), manufacturer (drug), MaPP, mapping, marketing authorization, marketing authorization holder, marketing authorization procedure, marketing support trials, markup, masking, master protocol, master protocol, matched-pair design, maximum, Mbps, MCM, MDR, MDSAP, mean, mean, MedDRA, MedDRA (Medical Dictionary for Regulatory Activities), median, median, medical countermeasure, medical device, medical monitor, medical monitoring, medication error, medicinal product, medicinal product classification, medicinal product identifier, medicinal product name, Medicines and Healthcare products Regulatory agency (MHRA), MedID, MEDLARS, MEFA, mega-trials, memorandum of understanding (MOU), MEP, message (HL7), meta-analysis, meta-analysis protocol, metabolism, metadata, MHLW, MHRA, MIAME, MIC50, migration, minimal, minimum, minor, minor, missing data, missing data, MOA, mode, model, modem, MOH, moiety, monitor, monitor, monitoring, monitoring plan, monitoring report, monitoring visit, MOPH, morbidity, morbidity rate, morbidity rate, mortality rate, mortality rate, MOU, MPDT, MPID, MPR, MR, MRA, MREC, MRI, MRP, MTD, multicenter trial, multicenter trial, mutual recognition procedure (MRP), MVP, N of 1 trial, n-of-1 study, NABR, NAF, NAI, NAS, NAS–NRC, natural language, natural language processing, NBAC, NCA, NCE, NCI, NCI Enterprise Vocabulary Services (EVS), NCICB, NEFARMA, negative test result, negative test result, negligible, NEI, neoadjuvant therapy, NEST, neural network, new chemical entity (NCE), New Drug Application (NDA), new molecular entity (NME), new safety information, NGO, NHI, NHIN, NHLBI, NHS, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIH, NIMH, NIMP, NINDS, NINR, NIRB, NIST, NLM, NME, NME, NOAEL, NOEL, NOEL (no observable effect level), nomenclature, non-compliance, non-confirmatory result, non-inferiority (NI) trial, non-inferiority trial, non-interventional (observational) study, non-interventional study, nonclinical study, not approvable letter, Notified Body (NB), NRB, NSCLC, NTP, null hypothesis, Nuremberg Code.


OAI, OASIS, objective, objective, observation, observational study, observational study, observational study (prospective), observational study (retrospective), observe, observer assessment, observer-reported outcome (ObsRO), ObsRO, occasionally, ODAC, odds ratio, ODE, ODM, off-label, off-label, official protocol title, OGD, OGE, OHITA, OHRP, OIG, OIQ, OIS, OJEC, OMB, ONCHIT, ontology, open to enrollment, open-label, open-label study, operational definition, operational model, opinion (in relation to independent ethics committee), OPR, OPRR, original data, OSHA, OTC, other serious (important medical events), outcome, outcome (of adverse event), outcome (of study), outcome measure, outcome measure, outcome of study, outcomes research, outliers, overdose, p-value, p-value, PAB, packaging, PADER/PAER, PAHO, pairing, palliative therapy, pandemic, parallel trial, parameter, participant, participate, password aging, patient, patient file, Patient Reported Outcomes (PROs), patient-generated health data, patient-reported outcome (PRO), PBRER, PCC, PD, PD, PDF, PDQ, PDR, PDUFA, PDUFA IV, peer review, peer review, PEM, per-protocol analysis set, PerfO, performance outcome (PerfO), performed activity, period effect, periodically, permanent data, permissible values, personal data retention, personally identifiable information (PII), PFT, PGT, PGX, pharmaceutical product, Pharmacodynamic (PD) study, pharmacodynamics, pharmacoeconomics, pharmacogenetic test, pharmacogenetics, pharmacogenomic test, pharmacogenomics, Pharmacokinetic (PK) study, pharmacokinetics, pharmacology, pharmacovigilance, pharmacovigilance, phase, phase, phase (within a study), phase 1, phase 2, phase 2a, phase 2b, phase 3, phase 3b, phase 4, phase 5, PHE, PHI, PhPID, PhRMA, PHS, PI, PII, pilot study, PIM, PK, PKI, PLA, placebo, placebo, placebo-controlled study, placebo-controlled study, plain language writing, platform trial, platform trial, platform trial design, PLSP, pm, PMA, PMDA, PMS, PO, population, positive test result, positive test result, post-market surveillance, post-trial access, postmarketing commitment (PMC), postmarketing requirement (PMR), postmarketing surveillance, PPD, PPI, PPO, PR, pragmatic clinical trial, pragmatic elements, pragmatic trial, pre-approval access, pre-market approval application (PMA), preamble, preclinical studies, preclinical study, prevalence, prevalence, PRIM&R, primary completion date, primary endpoint, primary objective, primary outcome variable, principal investigator, privacy breach, PRM, PRO, probability, probability, procedures (for participants), processing (personal data), product dose, PROG, progression-free survival, progression-free survival, PROMIS, PROMIS, propensity score, prophylaxis, proprietary name, prospective study, prospective study, protected personal data (PPD), protocol, protocol, protocol amendment(s), protocol approval (Sponsor), protocol deviation, Protocol Identifying Number, protocol referenced documents, protocol title, protocol violation, proxy, proxy (as an origin of outcome measures), proxy respondent, proxy-reported outcome, pseudonymization, pseudonymized, PSUR, psychometric reliability, psychometric validation, psychometrics, PTC, public protocol title, purpose, PV.


QA, QAU, QC, QD, QID, QL, QOL, QRS, qualitative variable, quality assurance (QA), quality control (QC), Quality of Life (QOL), quality of life (QoL), quantitative variable, query, query management, query resolution, questionnaire, questionnaire, R&D, race, RADAR, radiopharmaceutical medicinal product, random allocation, random number table, random sample, randomization, randomization, randomized controlled trial, randomized controlled trial (RCT), RAPS, rationale, raw data, RBM, RCRIM, RCRIM, RCT, RDE, RDF, RDRC, Real World Data (RWD), Real World Evidence (RWE), Real-World Data (RWD), Real-World Evidence (RWE), REB, rechallenge, RECIST, reconstruction (of a study), record, record retention, recruitment (investigators), recruitment (subjects), recruitment period, recruitment target, Reference information Model (RIM), reference member state (RMS), regenerative medicine, regenerative medicine advanced therapy (RMAT) designation, regenerative medicine therapy (RMT), registry, registry, regulatory application, regulatory authorities, reimburse, relative risk, relative risk, remote clinical trial, REMS, REMS, repeat rule, replacement, report, repository, rescue medications, research hypothesis, residual confounding, residual risk, response option, result synopsis, results (study), results posting (results submission), results posting date (results submission date), retrospective data capture, retrospective study, retrospective study, RFD, RFP, RHIO, RHIO (Regional Health Information Organization), RIM, risk, Risk Evaluation and Mitigation Strategy (REMS), risk-based monitoring, risk-benefit assessment, risk-benefit ratio, risk-benefit ratio, risks of a research study, RKI, RL, RMAT, RMP, RMS, RMT, RNA, ROA, role (CDISC classifier), route of administration (ROA), RPS, RR, RSI, RWD, RWE.


SACHRP, SADR, SAE, SAFE, SAFE, safety, safety and tolerability, SaMD, sample size, sample size, sample size adjustment, sample size calculation, SARS-CoV-2, SAS, SATCM, SBA, SC, SCDM, schedule of activities, schedule of assessments, schedule of assessments, screen failure, screen/screening (of substances), screening, screening (of sites), screening (of subjects), screening (period), screening trials, script, SCT, SD, SD, SDA, SDM, SDO, SDS, SDSP, SDTM, SDTMIG, SDV, SE, SEA, secondary endpoint, secondary objective, secondary outcome variable, secondary sponsor, SEER, selection bias, self-evident change, semantic, semantic interoperability, SEND, SEND (standard for the exchange of nonclinical data), sensitive data, sensitivity, sensitivity (medical test), sequential, Sequential Multiple Assignment Randomized Trial (SMART), serious adverse drug reaction, Serious Adverse Event (SAE), serious adverse event (SAE), serious adverse experience (SAE), serious breach, serious risk, server, severe, sex, SFDA, SGML, SHARE, side effect, side effect, SIG, sign, signal of a serious risk, single-blind study, single-blind study, single-entity product, site investigator, SLA, SMART, SME, SMO, SmPC, SNDA, SNIP, SNOMED, SNOMED (Systematized Nomenclature of Medicine), SoA, SOAP, SOC, social circumstances, SoCRA, software, software as a medical device (SaMD), software validation, software verification, SOP, source, source data, source data verification, source document verification (SDV), source documents, SPAC, SPC, special populations, special purpose domain, specificity, specificity (medical test), specified substance, SPIRIT, SPL, SPM, sponsor, sponsor, sponsor-investigator, SQA, SQAP, SSC, SSCT, SSFA, standard, standard deviation, standard of care, standard of care, standard operating procedures (SOPs), standard treatment, Standards Development Organization (SDO), statistical analysis plan, statistical distribution, statistical method, statistical power, statistical significance, statistically significant, stem, stepped wedge cluster randomized trial, STF, stochastic, stopping rules, stratification, structured data, structured health record information, structured product label (SPL), STT, study arm, study compensation, study completion, study completion date, Study Data Standardization Plan (SDSP), study description, study design, study design, study design rationale, study design schematic, study feasibility, study feasibility, study intervention, study life cycle, study life cycle, study monitoring, study participant, study participant, study population, study population, study publication date, study reimbursement, study report completion date, study results, study start, study start date, study statistician, study variable, SUAE, sub-investigator, subject completion, subject data event, subject identification code, subject monitoring, subject trial contact, subject-reported outcome (SRO), submission model, subprocessor, substudy, SUD, superiority trial, superiority trial, supplier (system), surrogate endpoint, surrogate marker, surrogate variable, survey, SUSAR, suspension (of a clinical trial), SWOG, symptom, synergistic effect, synergistic effect, synopsis, syntactic, synthetic data, synthetic data, system, t-test, table of roles and responsibilities, tabulation dataset, TAC, target enrollment, target population, target trial emulation, TC, TCC, TCP/IP, technology provider, temporary halt (of a clinical trial), term, TermID, termination (of a clinical trial), terminology, TESS, TGA, therapeutic area, therapeutic effect, therapeutic index, time, time, time (FSI - date, time (LSI - date, time (LSLV - date, time), time), time), time-related bias, TIND, TK, Tmax, TMO, token, tolerability, traceability (data), transcription, transition rule, translation, translational research, transmit, treatment, treatment benefit, treatment contrast interaction, treatment effect, treatment effect, treatment-emergent adverse event, trial design element, Trial Design Model, trial site, trial statistician, triple-blind study, trustworthy (electronic records), type 1 (or type I) error, type 2 (or type II) error, type 3 (or type III) error, type of comparison.


UAT, UCUM, umbrella trial, umbrella trial, umbrella trial design, UMT, unblinding, unexpected adverse drug reaction, unexpected serious risk, uniform resource locator (URL), URL, USAN, USC, USDA, use case, use error (device), user site testing (UST), USP, UST, UT, UTC, UUID, VA, vaccine, vaccine effectiveness, vaccine efficacy, VAERS, VAI, valid, validate, validation, variable, variance, VCDE, verification, verification of data, VGDS, virtual, virulence, visit, vocabulary, voluntary participation, volunteer, VPN, vulnerable subjects.


510(k), W3C, WAN, Warning Letter, wash-out, washout period, web browser, web page, web scraping, web server, website, weighting, well-being (of the trial subjects), WHO, WHOART, WHODRUG/WHO-DRL, withdraw, withdrawal, within-subject differences, WL, WOCBP, World Wide Web, WR, WRAIR, WTO, WWW, X-ray, XML, XML (eXtensible Markup Language), zoonosis, A&WC.