Datacapt uses one builder for five modules, so some words are generic: "section" where a clinical team says "visit". This list gives both.
A to C
Allocation. The assignment of an investigational product kit to a subject, from the kit inventory of the study.
Anchor visit. In a recruitment study, the visit (D0, baseline) that other appointments refer to.
API key. A personal key created under Settings › API. A program uses it to read or write Datacapt data with your permissions.
Audit trail. The log of who did what and when. Datacapt keeps three: one per question, one per study, one for the platform.
Automation. A rule that sends an email or an ePRO when an event occurs, for example "Subject included" or "Queries Created".
Blinded / Unblinded. The blinding status of a randomized subject. A role sees the treatment arm when it holds Unblind Access, or after an emergency unblinding.
Block. Any element of a form: a question, a static content, a repeated measure, a table, a button.
Calcul. A question that computes its value from other answers.
Center. A site. The center abbreviation enters the subject ID.
Conditional logic. A rule that shows a question, a form or a visit, or prefills an answer, depending on another answer.
D to E
Data validation. An edit check. A rule on a question that displays a message and raises an automatic query when the answer fails it. Four severities: Information, Warning, Exclusion, Disqualified.
Datacapt ID. The platform-wide identifier of a participant, distinct from the subject ID of a study.
Dictionary. A medical coding dictionary, MedDRA or WHODrug, loaded under Settings › Dictionaries.
Domain. An optional label on a section, used to group forms in the Domains export (DM, VS, AE).
Draft. The first status of a study. You build and test. Go-live deletes test data.
eConsent. The electronic informed consent form and its signed records.
eCRF. The electronic case report form, filled in by the site. One eCRF per study.
eCRF record. The eCRF of one subject. Also named inclusion.
eCRF Review. The study setting that switches on form review and SDV.
Emergency unblind. The action that reveals a subject's arm, with password and reason. The audit trail records it.
Ended. The study status that locks all data. Export stays available.
ePRO. A questionnaire answered by the participant, on a phone or a computer.
Exclusion. Removing a subject from the eCRF, with a reason and your password. Reversible.
G to M
GCP (Enable GCP). The study setting that asks for a reason at each change of a saved answer.
Hide in eCRF. A question option. The site does not see the question; the export contains it.
Inclusion. See eCRF record. The Inclusions list shows every subject's eCRF.
Items Dictionary. The sheet of each eCRF export that lists every variable with its type, values, validations and conditions. The data dictionary of your study.
Live. The study status for real data. The Builder is locked.
Lock. Freezing a form, a visit or a whole record against changes. Datacapt refuses a lock while a query on that scope is open.
Mapping. In medical coding, the link between an eCRF question and a dictionary.
MFA. Multi-factor authentication with an authenticator app.
Missing data. A declared absence of an answer, with a standard reason.
Monitoring. The dashboards for queries, review, SDV and missing data.
P to R
Participant / Subject. The person in the study. "Participant" in recruitment and the Subject Database, "subject" in the eCRF.
Prefix / Suffix. Text added by a section to the variable names of its questions: V2_SBP.
Query. A question raised on a data point, by a user (manual) or by a data validation (automatic). Statuses: Opened, Resolved, Closed.
Randomization. Assignment of a subject to a treatment arm, by static list or dynamic algorithm.
Reason for change. The justification a user types when changing a saved answer, under GCP.
Repeated measures. A block the site fills several times: adverse events, treatments.
Review. A monitor's stamp that a form has been read.
Role. A set of permissions. Platform roles govern settings; study roles govern a study.
S to W
SDV. Source data verification. A monitor's stamp that an answer matches the source document. Statuses: Verified, Unverified.
Section. The first level of a form. In an eCRF, a visit (event).
Signature. The investigator's electronic signature of a visit, with email and password. A signed visit is locked for editing.
SSO. Single sign-on with your company account (SAML 2.0).
Static content. A block that displays and collects nothing: Header, Instruction, Image.
Sub-section. The second level of a form. In an eCRF, a form inside a visit.
Subject Database. The cross-study repository of participants.
Subject ID. The identifier of a subject in one study, built from the pattern you set.
Suspended. The study status that reopens the Builder and blocks data entry.
Table/Matrix. A grid block with fixed rows and columns.
Template. A saved eCRF, section, sub-section or question, reusable across studies of your instance.
Variable. The technical name of a question. It becomes the column header in exports.
Verbatim. The text a site typed, waiting for a medical code.
Washout. The period during which a participant cannot join another study on the same body zone.