64 terms across 6 categories. Every acronym and concept used across the platform — ALCOA+, Part 11, autonomy classes, GAMP 5, CDISC, RAG, and more.
FDA regulation governing electronic records and electronic signatures. Every regulated promotion on this platform passes through a Part 11 gate: re-authentication, stated intent, and an immutable signature row.
See also: ALCOA+, GxP, E-signature, FDA
A human performs the task end-to-end. The agent is not involved in decision-making or execution. Default for any task whose risk profile has not been evaluated.
The agent suggests; the human decides and acts. The agent never writes to any system of record. Suitable for drafting, summarizing, or surfacing options.
The agent proposes an action and writes the proposal to staging. A signed human review (re-auth + intent + Part 11 signature row) is required before the action is promoted to live. Default class for regulated work on this platform.
See also: A1, A3, 21 CFR Part 11, Staging
The agent executes within a narrowly scoped, pre-approved policy and notifies a human after the fact. Reserved for low-risk operational tasks; never used for regulated writes.
Prohibited on this platform. A4 would mean the agent acts on regulated systems without any human gate. Architecturally blocked in packages/policy/.
Data must correctly represent what was observed. The platform enforces this via citation grounding on authoring agents and reviewer sign-off before promotion.
See also: ALCOA+, Citations
CDISC standard for analysis-ready clinical trial datasets. Derived from SDTM. Used by statisticians to produce the TLFs and CSR analyses.
The FDA / MHRA data-integrity framework. Every regulated write on this platform carries the metadata needed to satisfy all nine pillars. See each pillar entry for what it means in practice.
See also: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available
The LLM provider for this platform. Sonnet 4.7 is the default; Opus 4.7 is used for high-stakes reasoning. Model IDs are pinned in packages/model-registry/.
See also: Model registry, RAG
Every record must identify who created it. The platform records created_by, signed_by, and a full provenance_event chain for every regulated write.
See also: ALCOA+, Provenance
Data must be retrievable on demand throughout the retention period. Inspection-ready exports are produced from the provenance store and signature events.
See also: ALCOA+
The standards body behind SDTM, ADaM, CDASH, and related clinical data models. Submission-ready data must follow CDISC standards for FDA and most other regulators.
All data, including repeats and reanalyses, must be retained. The platform never deletes provenance rows; corrections are recorded as new events with links to the original.
See also: ALCOA+, Provenance
Records must follow the same sequencing and use synchronized, traceable timestamps. The platform timestamps every event in UTC (timestamptz) and orders by the database clock.
See also: ALCOA+
Records must be created at the time of the activity. Agent actions write provenance events synchronously; signatures capture the wall-clock signing time, not the action time.
See also: ALCOA+
FDA-promoted, risk-based successor to CSV. Focuses validation effort on patient safety and data integrity rather than exhaustive documentation. The validation route shows CSA-style evidence.
The ICH E3 final report of a clinical trial: design, conduct, results, discussion. Authored by medical writing; backed by the SAP, ADaM datasets, and TLFs.
Traditional GxP system validation: requirements, design, OQ/PQ testing, traceability. Largely being superseded by CSA for GxP software.
The system of record for study operations: sites, visits, milestones, monitoring activity. The platform integrates with CTMS through services/integrations/ctms/.
The TypeScript ORM used across this monorepo. Schemas live in packages/schema/. drizzle-kit generates SQL migrations that are applied to Supabase.
See also: Supabase
The Part 11 act that promotes a staged record to live. Requires re-authentication, an explicit stated intent, and writes an immutable signature row referencing the action.
See also: 21 CFR Part 11, Staging
Tablet/phone-based capture of patient-reported, clinician-reported, or observer-reported outcomes. Feeds EDC.
The system clinical sites use to enter subject-level data (eCRFs). The platform reads from and writes to EDC through services/integrations/edc/, never directly.
The European Union regulator for human and veterinary medicines. Counterpart to the FDA; relies on the same ICH-GCP framework.
Records must persist for the full regulatory retention period (often 25+ years). Provenance and signature rows are append-only and backed up off-site.
See also: ALCOA+
The regulated document repository for a clinical trial — the inspector first stop. Indexed against the DIA TMF Reference Model. Agent 04 (Essential Documents) writes proposed eTMF entries to staging.
The FDA database of post-market adverse event and medication error reports. ICSRs about US-marketed products typically flow into FAERS via E2B(R3).
The U.S. regulator for drugs, biologics, and devices. Issues 21 CFR Part 11, GxP guidance, and the CSA framework. Inspections are the headline risk this platform is built to survive.
See also: 21 CFR Part 11, EMA, GxP, CSA
ISPE risk-based framework for validating computerized systems in regulated industries. GAMP 5 (2nd ed.) embraces critical thinking and CSA over checklist-driven CSV.
The ICH E6 international standard for designing, conducting, and reporting clinical trials. Applies to every study this platform supports.
The quality system for non-clinical laboratory studies (typically toxicology). Sibling of GCP and GMP under the GxP umbrella.
The quality system for drug and device manufacturing. Not the platform primary scope, but cross-references appear in supply chain and IMP handling.
Collective term for the regulated quality systems: GCP, GLP, GMP, GVP, etc. Any system that touches GxP data must be validated and Part 11 compliant.
See also: GCP, GLP, GMP, 21 CFR Part 11
The harmonized GCP guideline (ICH E6) adopted by FDA, EMA, PMDA, and others. The reference framework for every interventional study on this platform.
A structured report of one adverse event for one subject. Transmitted to regulators (FDA via FAERS, WHO via VigiBase) using the ICH E2B(R3) format. AI never makes the causality call.
A study sponsored by the investigator rather than a pharmaceutical company. Often phase 1 or 2 academic studies; same GCP and Part 11 rules apply.
Durable workflow / job runtime. Deferred for the demo era (per ADR 0006) in favor of Vercel Cron + Supabase pg_cron. Re-evaluate when durable multi-step workflows or fan-out retries become unavoidable.
See also: Vercel Cron
Records must be readable and permanent. Stored as structured JSON in Postgres with human-readable rendered views in the inspection package.
See also: ALCOA+
The standardized medical terminology used to code adverse events, indications, and medical history. Licensed from MSSO; required for ICSRs.
Internal registry pinning every prompt + model version used by an agent. CI fails if a prompt diff lands without a corresponding registry row bump.
See also: Anthropic Claude
Graph database originally planned for relationship-heavy agent reasoning. Deferred per ADR 0006 until an agent genuinely needs graph traversal.
See also: pgvector
Internal CRO operations system covering resourcing, contracts, and finance. Distinct from CTMS (study ops) and eTMF (documents).
Records must be the first capture, or a verified true copy. Staging carries the original proposal; promotion produces a true copy bound to the signature.
The Postgres extension storing embedding vectors for similarity search. Enabled on the Supabase project; powers RAG retrieval without a separate vector database.
First-in-human studies focused on safety, dose, and pharmacokinetics. Small cohorts, often healthy volunteers (except in oncology).
Establishes preliminary efficacy and refines dose in the target patient population. Typically a few hundred subjects.
Pivotal efficacy and safety trial supporting marketing authorization. Hundreds to thousands of subjects, often global and multi-site.
Post-marketing studies conducted after approval to monitor long-term safety, real-world effectiveness, or new indications.
The append-only log (provenance_event table) recording every regulated action: who, what, when, why, with which model and prompt version. Powers ALCOA+ and inspection exports.
See also: ALCOA+, Attributable
The discipline of detecting, assessing, and preventing adverse effects of medicinal products. The platform supports PV authoring but never determines causality.
LLM pattern that retrieves relevant documents (via vector search) and grounds the model response in them. The platform knowledge-RAG agent uses pgvector for retrieval and citation grounding for trust.
See also: pgvector, Anthropic Claude
ICH E6(R2/R3) framework that focuses monitoring and oversight on the highest-risk processes and data. Drives the risk register surfaced on the risks route.
System that randomizes subjects to treatment arms and manages drug supply / dispensation. Integrates with EDC for kit codes and unblinding workflows.
Pre-specified document describing every analysis to be performed in a study. Locked before database lock so analyses cannot be cherry-picked.
CDISC standard for the tabulated raw clinical data submitted to regulators. Input to ADaM. Required by FDA for most NDA/BLA submissions.
Comparing EDC entries against source documents at the site. RBQM has shifted this from 100% SDV to risk-targeted SDV.
Controlled document describing how a regulated activity must be performed. Every agent on this platform maps to one or more SOPs that govern its scope.
The only store agents are permitted to write to. Records sit in staging with state proposed/reviewing until a signed human promotes them to live. Enforced by packages/policy/ and the orchestrator governor.
See also: A2, E-signature, 21 CFR Part 11
Managed Postgres + Auth + Realtime used as the platform data spine. Project ref clkifpedvomnpgajdsid, us-east-1, pgvector enabled, RLS deny-by-default.
The statistical outputs produced from ADaM datasets according to the SAP. The raw material from which medical writing assembles the CSR.
Scheduled-job mechanism for the demo era (ADR 0006). Vercel Cron triggers HTTP endpoints; pg_cron handles in-database periodic work. Replaces the originally planned Inngest workflows.
See also: Inngest
The World Health Organization global database of suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre. Counterpart to FAERS.
The standardized dictionary of medicinal product names used to code concomitant medications and prior therapies in clinical trials. Counterpart to MedDRA for drugs.