Clinical terms, platform terms, and the regulatory acronyms that appear in this library.
The platform's own words
| Term | Meaning |
|---|---|
| Organization | Your company: a sponsor, a CRO, a site network. Owns its people and studies and never sees another organization's data |
| Super-Admin | A person who runs the platform itself, in the platform console. Not an organization's administrator, and sees no clinical data |
| Organization Admin | The administrator of one organization. Governs people, roles and studies and holds no study role |
| Control plane and data plane | The two applications: the platform console (organizations, feature switches, the platform ledger) and the trial application (studies, people and data) |
| Study | One clinical trial. Everything else lives inside a study |
| Site | A hospital or clinic taking part |
| Participant | A trial participant. Some screens and API names say subject |
| Visit | A scheduled protocol appointment |
| Visit instance | One participant's copy of a visit, with its own date |
| Visit window | How many days before and after the scheduled date a visit is on time. Entry before the window opens needs early access; a visit after it is flagged out of window |
| Form | An electronic case report form: the page of questions filled in at a visit |
| Record | One participant's answers to one form at one visit. This is what gets signed |
| Event form | A form recorded when something happens off the schedule: an adverse event, a serious adverse event, a medication, another event the study tracks |
| Casebook | The grid of the study (a participant for each row, a visit for each column) showing what is complete, queried, verified and signed; each participant also has their own |
| Version | A numbered, sealed snapshot of the study design: forms, visits, mapping and rules go live together. Its states are Build, UAT, Awaiting sign-off, Approved, Live and Superseded (or Withdrawn) |
| Snapshot and content hash | The compiled design a version is frozen into when it is submitted to UAT, with a fingerprint of its content. Sign-offs and design exports carry the hash |
| Amendment | A new version built beside the Live one after the study is running |
| UAT cycle | One round of testing of a frozen version on test data, ending in pass or fail |
| Workspace | UAT or Live: where a study's test data or production data lives. They never mix |
| Study state | Setup, Active, On hold, Closed to enrolment, Completed, Locked or Archived (Statuses) |
| Query | A question about a value, with a thread of replies |
| Auto-query | A query opened by an edit check or a rule rather than by a person |
| Edit check and severity | A rule on a field, with a severity of Query, Block or Warn that decides what a failing save does |
| Rule | A study-level check that can look across forms |
| SDV plan | Which fields, forms and visits a monitor must verify against source |
| Stale (verification) | A verification whose value has since changed; it returns to the monitor's queue |
| Delegation of authority | The investigator's signed authorization of a site staff member, with dates |
| Step-up code | The fresh one-time code a signature asks for, valid for that record and meaning only |
| Reason for change | The written explanation required when an already-entered value is modified |
| Early access | A recorded exception permitting data entry before a visit's window opens |
| Awareness time | When the site learned that an event was serious; the reporting clock starts here |
| Reconciliation | The record that a serious event agrees, or does not, with the safety database |
| Lock request | The first of the two signed steps of a database lock; a second person confirms it |
| Feature switch | A per-organization on or off setting for a licensed feature, set in the platform console |
| Access exception | A time-limited addition or removal of one permission on one grant, with a reason and, for a risky permission, a second approver |
| Hash chain | The way each audit entry stores the hash of the one before it, so a change anywhere in the trail shows |
Clinical and regulatory terms
| Term | Meaning |
|---|---|
| AE | Adverse event |
| SAE | Serious adverse event |
| SUSAR | Suspected unexpected serious adverse reaction. In Trialion a flag on a related and unexpected serious event, and nothing more |
| ALCOA+ | Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available: the data-integrity standard |
| Arm | A treatment group in a randomized study |
| Baseline | The reference date from which the visit schedule is calculated |
| Blinding | Concealing treatment allocation from participants, investigators, or both. Not built (Not built yet) |
| CDASH | CDISC's standard for how case report forms are structured |
| CDISC | Clinical Data Interchange Standards Consortium: the body behind ODM, SDTM and CDASH |
| CRA | Clinical Research Associate: the monitor |
| CRC | Clinical Research Coordinator: the site coordinator |
| CRF / eCRF | Case report form, electronic case report form |
| CRO | Contract Research Organization |
| CSV | Computer System Validation. (Also a file format; context distinguishes them) |
| Database lock | Freezing the data for analysis. In Trialion it takes two different people |
| Deviation | A departure from what the protocol requires |
| DMC / DSMB | Data Monitoring Committee / Data and Safety Monitoring Board |
| E2B | The standard for electronic transmission of individual case safety reports. Not produced |
| EDC | Electronic Data Capture |
| Eligibility | The investigator's determination that a participant meets inclusion and exclusion criteria |
| ePRO / eCOA | Electronic patient-reported outcomes / clinical outcome assessments |
| GAMP 5 | The pharmaceutical industry's guidance on validating computerized systems |
| GCP | Good Clinical Practice |
| ICF | Informed Consent Form |
| ICH E6 | The international GCP guideline. R3 is the current revision |
| IMP | Investigational Medicinal Product |
| Informed consent | The participant's documented agreement to take part. Required before any study procedure |
| IQ / OQ / PQ | Installation, Operational and Performance Qualification: the three stages of validation |
| IRB / IEC | Institutional Review Board / Independent Ethics Committee |
| IRT / IWRS | Interactive Response Technology / Web Response System: randomization and supply |
| MedDRA | The dictionary used to code adverse events |
| Monitor | The person who verifies site data against source documents |
| ODM | CDISC Operational Data Model: the XML interchange format for clinical data |
| PI | Principal Investigator: the investigator of record at a site |
| Protocol | The document defining how the trial is conducted |
| Randomization | Allocating participants to arms by chance |
| SDTM | CDISC's Study Data Tabulation Model: the submission format |
| SDV | Source Data Verification: comparing captured data against the hospital's source document |
| SoD | Separation of duties: one person must not perform two conflicting steps |
| Source document | The original hospital record a value was taken from |
| Sponsor | The organization responsible for the trial |
| UAT | User Acceptance Testing: validating the study design before going live |
| WHODrug | The dictionary used to code medications |
| Withdrawal | A participant leaving the study early |
Regulations named in this library
| Reference | What it is |
|---|---|
| 21 CFR Part 11 | US FDA rules on electronic records and signatures |
| 21 CFR 56 | US FDA rules on institutional review boards |
| EU Annex 11 | The EU GMP annex on computerized systems |
| DPDP Act 2023 | India's Digital Personal Data Protection Act |
| GDPR | The EU General Data Protection Regulation |
| HIPAA | US health information privacy and security rules |
| ICH E2A | Guidance on safety data management, including expedited reporting timelines |
| ISO 27001 | The information security management standard |
| OWASP Top 10 | The most common web application security risks |