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Clinical Trials Glossary
Plain-language, current definitions of the acronyms that run clinical trials — from eTMF and CDISC to RBQM and 21 CFR Part 11.
For the acronym you were too busy to look up
You're three paragraphs into a monitoring report or a submission checklist when a four-letter acronym stops you cold. You know it matters. You do not have time to chase it down. So it goes on the mental pile with the others.
This is that pile, cleared. Every term below is defined in plain language, checked against the current standard version, and grouped by theme — the documents and the TMF, CDISC data standards, data management, statistics, safety, operations, and compliance. Search for the one you need, or skim a whole area to fill the gaps.
36 terms
Documents & TMF
- eTMFelectronic Trial Master File
- The electronic repository of essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. An eTMF replaces the paper Trial Master File and is expected to be inspection-ready at all times.
- TMF Reference Model
- An industry-standard taxonomy (stewarded under CDISC) that organizes TMF content into Zones → Sections → Artifacts — currently v3.3.1 with 250 artifacts across 11 zones. It standardizes what documents a trial should hold and where they belong.
- ICFInformed Consent Form
- The document by which a participant voluntarily confirms willingness to take part in a trial, after being informed of all relevant aspects. Governed by 21 CFR Part 50 and ICH-GCP; must include all required elements at an accessible reading level.
- Protocol
- The document that describes a trial’s objectives, design, methodology, statistical considerations, and organization. It is the foundational essential document from which the CRF, SAP, and much of the TMF are derived, and any change requires a formal amendment.
- IBInvestigator’s Brochure
- A compilation of the clinical and nonclinical data on the investigational product relevant to its study in humans. The IB carries the Reference Safety Information used to judge whether an adverse reaction is “expected” — the key input to a SUSAR determination.
Data Standards
- CDASHClinical Data Acquisition Standards Harmonization
- The CDISC standard for how data is collected on CRFs (current CDASHIG v2.1). CDASH is the front end that provides clean traceability into SDTM at the back end.
- SDTMStudy Data Tabulation Model
- The CDISC standard for organizing and formatting collected clinical trial data for regulatory submission (current SDTM IG v3.4), structured into domains such as DM, AE, LB, and VS.
- ADaMAnalysis Data Model
- The CDISC standard for analysis-ready datasets (current ADaM IG v1.3), derived from SDTM with full traceability. ADaM datasets (ADSL, ADAE, ADLB, etc.) feed the statistical outputs.
- Define.xmlDefine-XML
- The machine-readable metadata (data-definition) file that describes SDTM and ADaM datasets for a submission (current v2.1), accompanied by the Reviewer's Guides (SDRG/ADRG).
- Pinnacle 21
- The de-facto CDISC conformance validation tool (now Certara Pinnacle 21) used to check SDTM/ADaM datasets and Define.xml against CDISC and FDA rules before submission.
- aCRFannotated Case Report Form
- A blank CRF marked up with the SDTM domain and variable mappings for each field. It documents where every collected value lands in the submission datasets and is itself a required piece of submission metadata.
Data Management
- EDCElectronic Data Capture
- Software used to collect clinical trial data electronically, replacing paper case report forms. Major platforms include Medidata Rave, Oracle Clinical, and Veeva.
- CRF / eCRF(electronic) Case Report Form
- The form used to capture protocol-required data for each participant. The eCRF is its electronic version in an EDC; the annotated CRF (aCRF) adds SDTM variable mappings.
- DMPData Management Plan
- The controlled document defining how a study’s data will be captured, validated, cleaned, queried, coded, reconciled, and locked — the operating manual for the data management team.
- SDVSource Data Verification
- Checking that data recorded in the EDC matches the underlying source records. Under RBQM, SDV is targeted at critical data and higher-risk sites rather than performed 100% across every field.
- Database LockDBL
- The point at which the clinical database is frozen after data cleaning, query resolution, and reconciliation are complete. No further changes are permitted without a controlled, documented unlock. Lock gates unblinding and the primary statistical analysis.
Statistics
- TLF / TLGTables, Listings, and Figures (Graphs)
- The statistical outputs generated from ADaM datasets that present a study's safety and efficacy results, built to CDISC/FDA conventions and validated against approved mock shells.
- SAPStatistical Analysis Plan
- The detailed plan describing the statistical methods and analyses to be performed on trial data, finalized before database lock and unblinding.
- CSRClinical Study Report
- The comprehensive report of a completed trial, structured per ICH E3, that integrates the protocol, SAP, and statistical outputs into a submission document.
Safety
- AE / SAE / SUSARAdverse Event / Serious AE / Suspected Unexpected Serious Adverse Reaction
- The escalating safety hierarchy: an AE is any untoward medical occurrence; an SAE meets seriousness criteria; a SUSAR is a serious reaction that is both suspected to be causally related and unexpected — subject to expedited reporting.
- ICSRIndividual Case Safety Report
- The standardized report of adverse-event information for a single patient, the unit of exchange in pharmacovigilance and signal detection.
- MedDRAMedical Dictionary for Regulatory Activities
- The standardized medical terminology used to code adverse events, medical history, and indications into a consistent hierarchy (SOC → PT → LLT) for safety analysis and regulatory reporting.
- WHODrug
- The WHO Drug Dictionary, maintained by the Uppsala Monitoring Centre, used to code concomitant and prior medications to a standardized hierarchy so that drug exposure can be analyzed consistently.
- DSURDevelopment Safety Update Report
- The annual, harmonized safety report (ICH E2F) that summarizes an investigational product’s evolving safety profile across ongoing clinical development, submitted to regulators and ethics committees.
Operations
- CTMSClinical Trial Management System
- The operational system of record for running a trial — sites, visits, milestones, monitoring, and payments. Distinct from the eTMF, which is the document repository; most sponsors run both.
- RBM / RBQMRisk-Based (Quality) Monitoring
- The ICH E6(R3) approach to overseeing trials by focusing monitoring effort on the risks that matter most. RBQM is the end-to-end umbrella; RBM is the monitoring subset. Uses centralized and reduced on-site monitoring.
- KRIKey Risk Indicator
- A metric monitored across sites to signal emerging risk to trial quality or safety, evaluated against thresholds and quality tolerance limits (QTLs).
- QTLQuality Tolerance Limit
- A pre-defined limit of acceptable variation for a parameter important to participant safety or data reliability; a breach prompts review under ICH E6(R3).
- RTSM / IWRS / IRTRandomization & Trial Supply Management
- The system managing randomization and investigational-product supply. RTSM is the modern umbrella term; IRT (Interactive Response Technology) spans IWRS (web) and legacy IVRS (voice).
- Blinding / Unblinding
- Blinding conceals treatment allocation from participants and/or study staff to reduce bias; unblinding reveals it. Unblinding is done in a controlled way — for a safety emergency, or planned at analysis after database lock — with a full audit trail.
Compliance
- 21 CFR Part 11
- The FDA regulation governing electronic records and electronic signatures — covering attributability, audit trails, and signature manifestation for GxP systems.
- CSV / CSAComputer System Validation / Computer Software Assurance
- The documented process ensuring a computerized system does what it is intended to do (URS/FRS, IQ/OQ/PQ). CSA is the FDA's risk-based evolution of CSV emphasizing critical-thinking and testing effort where risk is highest.
- ALCOA+
- The data-integrity principles: data must be Attributable, Legible, Contemporaneous, Original, and Accurate — plus Complete, Consistent, Enduring, and Available.
- GAMP 5Good Automated Manufacturing Practice
- The ISPE risk-based framework for validating computerized systems in regulated life-science environments, widely referenced for CSV/CSA.
- ICH E6(R3)
- The current Good Clinical Practice (GCP) guideline (finalized January 2025), which embeds quality-by-design and risk-based approaches into trial conduct and oversight.
- GxP
- The umbrella for the “Good x Practice” regulations that govern regulated life-science work — including GCP (clinical), GLP (laboratory), GMP (manufacturing), and GVP (pharmacovigilance). Any system that touches trial data must meet the relevant GxP expectations.
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