Glossary

Trial-world terms first, then the words this system uses with a specific meaning. Regulatory entries here are deliberately brief identifications, not summaries of requirements; the compliance mapping is the page that makes precise claims, with sources.

People and organizations

Sponsor: The organization responsible for the trial, often the company or institution funding it. This system is built for the sponsor-side (or CRO-side) oversight seat.
CRO (Contract Research Organization): A company the sponsor hires to run some or all of the trial’s operations, including monitoring.
CRA (Clinical Research Associate): The monitor: visits sites, verifies the trial is run to protocol, writes trip reports, and raises findings.
Study coordinator: Site-side staff who run the day-to-day of the trial at their site, including keeping the site’s documents in order.
PI (Principal Investigator): The physician responsible for the trial at one site. Sub-investigators assist under the PI’s supervision.
IRB / IEC: Institutional Review Board (US) / Independent Ethics Committee (elsewhere): the body that reviews and approves the trial’s protocol and consent documents to protect participants. Its approvals are among the documents this system tracks.
Site: A hospital or clinic where the trial enrolls participants. In this system a study-site is one site’s participation in one study.

Documents and files

TMF (Trial Master File): The collection of documents that together demonstrate a trial was conducted properly. An eTMF is its electronic form. ICH’s GCP guideline calls the things it must contain essential records.
TMF Reference Model: A CDISC-maintained standard taxonomy for organizing TMF content into zones, sections, and artifacts. Document types in this system come from it; the zone headings you see on site pages are its zones.
eISF / eBinder: Electronic investigator site file, the site-side counterpart of the eTMF. Named here mostly for contrast: this system takes the sponsor/CRO view.
eTMF-EMS: The CDISC exchange mechanism standard for moving TMF content between systems. This system writes an eTMF-EMS package alongside its export, and files a partner’s package in through the same upload-and-review path as any other document: imported files land pending review, nothing arrives pre-approved.
Delegation of authority log: The site’s record of which study tasks the investigator has delegated to whom, from when. Kept here as structured entries beside the signed log document, so the system can check that the authorizer actually held the PI role and whether each delegate’s credentials are in order.
Training log: The site’s record of training completions (who, what topic, when, and until when), with current / expiring / expired status derived from the dates. An entry can link to the filed certificate document.
EDC (Electronic Data Capture): The system where subject-level clinical data is recorded. Deliberately not this system: ctms-core holds documents and site-reported aggregates only.
CTMS (Clinical Trial Management System): Software for running trial operations: sites, visits, issues, enrollment, milestones. The “ctms” in ctms-core.

Regulations and guidelines

GCP (Good Clinical Practice): The international ethical and scientific quality standard for conducting clinical trials, set out in ICH guideline E6.
ICH: The International Council for Harmonisation, which writes the technical guidelines (including E6) that most regulators adopt.
21 CFR Part 11: The US FDA regulation on electronic records and electronic signatures. The compliance mapping states, requirement by requirement, how this system addresses it and what remains the deploying organization’s responsibility.
GAMP 5: An industry good-practice guide for validating computerized systems in regulated environments. The validation guide describes the validation program in its terms.

Words this system uses precisely

Expected document: A document the study should have right now, according to a requirement rule, for example a current IRB approval at every active site. Expected documents exist before any file is uploaded; that’s what makes “missing” a status rather than a discovery.
Requirement rule: The declarative statement that generates expected documents (“every investigator needs a CV no older than 2 years”). Rules are data, and the site document matrix is their live evaluation.
Derived status: Any status computed at read time from recorded facts: document completeness, visit stages, issue states, milestone states. Never stored, never stale, never yours to update. The full list is in what the statuses mean.
Pending review: Uploaded but not yet approved. A pending-review document doesn’t count as current anywhere.
Returned (for correction): The review outcome besides approval: a reviewer sent the latest version back with a reason, which stays on the document’s permanent record. The returned version can never be approved; uploading a corrected version reopens review.
Review assignment: Routing a pending version to a named reviewer, with an optional due date. It has no “done” state of its own: approving or returning the version is what completes it, so the review queue can never disagree with the documents.
Bulk review: Approving (or returning) a selection of queued documents in one ceremony: you re-authenticate once, and every selected version gets its own signature bound to its own file. The audit trail shows N signatures, never one signature waved over N documents.
Site seat: Access scoped to a single site. A site-seat sign-in lands on that site’s page and works entirely there (uploads, signatures, the logs, enrollment reporting), with no study-wide view to get lost in.
Binder: The study rendered in TMF Reference Model order (zone, section, artifact), with filed documents and open gaps side by side. A single query over the same derived views as every other page: there is no binder to maintain, so none can drift.
Export package: The transfer-and-inspection package the system exports: every version’s bytes, the full metadata with signature hashes, and the entire audit chain, verifiable with standard checksum tools.
Waived: An expected document an administrator has marked not applicable, with a recorded reason (“central IRB of record; no local approval letter”). A waived requirement stops counting as a gap, but the placeholder and its waiver history stay on the record; if a document is filed anyway, the document wins.
Current / effective: Approved by signature and in force. “Effective” is the document’s own state; “current” is how a requirement row reports it.
Superseded: Replaced by a newer sibling document of the same type and scope. Kept forever, counted nowhere.
Version: One immutable uploaded file within a document. New uploads add versions; nothing ever edits or deletes an old one.
E-signature meaning: Every signature records why it was signed: approval, review, or authorship. In the app you’ll mostly meet approval signatures, which make documents effective.
Trip report: The CRA’s report of a monitoring visit. A real document with versions and signatures, linked to its visit; approving it is what advances the visit.
Action item: A finding from a visit that must be closed out: description, due date, resolution. Open action items keep a visit in follow-up.
Milestone: A named study date, planned versus actual: first site activated, database lock. Scoped to the study or to one site.
Audit trail: The automatic, append-only record of every change in the system: who, what, when, with before and after values. Written by the database itself, never by hand.
Hash chain: What makes the audit trail tamper-evident: each entry carries a cryptographic fingerprint of itself and the entry before it, so removing or altering any entry breaks the chain. The header badge re-verifies the whole chain continuously.
Hash-bound signature: A signature stored with the fingerprint of the exact file content signed. If the file ever differed, the signature would visibly not match. The document page’s Verify bytes control proves it on demand: the browser re-fetches the file, recomputes the hash locally, and compares it against the record and every signature bound to it.