Clinical Operations › Study Overview
System Configuration
System Configuration
Define which modules, systems, integrations, and metrics are active for this study. Changes are saved automatically.
Study Details
DCT Mode
Decentralized / Hybrid Trial Configuration
Summary
Module Scope ▾
Control which platform modules are active for this study. Deselected modules are hidden from the navigation sidebar. Study Overview and System Configuration are always enabled.
Infrastructure
Scope Shortcuts
Systems ▾
Toggle systems on or off for this study. Deselecting a system will flag dependent integrations.
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Integrations ▾
Select which integrations are in scope. Integrations whose required systems are deselected are flagged.
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Measurement
KPIs ▾
Select which KPIs are in scope for this study. Deselected KPIs are hidden from the KPIs tab.
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KRIs ▾
Select which KRIs are in scope for this study. Deselected KRIs are hidden from the KRIs tab.
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Operations
Site Roster ▾
Manage investigational sites for this study. Edits save automatically.
Systems
Study System Inventory
Systems selected for this study. Use ⚙ Configure to change selection.
Integrations
Integration Architecture
Integrations in scope for this study. All routed via enterprise API Hub with GxP audit trail.
AI · Stack Recommendation
Stack Architect
Describe the protocol and get a recommended system + integration architecture with rationale, cost, and validation effort — then create a study from it in one click. Existing studies are never modified.
Command · Self-Service Analytics
Self-Service Analytics
Native interactive dashboards over your live study data — build tiles, slice across them, drill in. No export to external BI required.
Intelligence · Competitive Landscape
Trial Benchmarking
Live comparable-trial benchmarks from ClinicalTrials.gov by indication — enrollment, duration, phase mix, common primary endpoints, and active geographies. Use to sanity-check study design against the public landscape.
Planning · Cost & Effort
Implementation Cost & Effort
Indicative roll-up of the selected stack — annual license, validation effort, ongoing FTE, and build timeline. Planning-grade estimates to support build-vs-buy and scope decisions. Click a system for detail.
Compliance · Validation Posture
System Compliance Matrix
Per-system regulatory and validation posture across the selected stack — GAMP category, 21 CFR Part 11 / EU Annex 11 applicability, CDISC alignment, and data-privacy scope. Click a system for detail.
Data Flow · Dependency Network
System Data-Flow Map
Selected systems shown as a connectivity network. Arrows show integration data-flow direction (source → target); larger ringed nodes are connectivity hubs — potential single points of failure. Click any node for system detail.
Integration Onboarding
Integration Onboarding Timeline
When each source system comes under TrialArchitect oversight — connector go-live readiness (in-build → ready → live), plus the implementation schedule below.
KPIs
Key Performance Indicators
Study-specific KPIs derived from protocol endpoints, operational requirements, and system SLAs.
KPI Formula / Measurement Target Frequency Owner Category
KRIs
Key Risk Indicators
Study-specific KRIs for multi-site perioperative immunotherapy — safety, data integrity, regulatory, and supply chain risks.
KRI Trigger Condition Severity Threshold Status / Trend Response Action Category
Sponsor Oversight
Portfolio Management
Cross-study operational intelligence — system standardisation, KRI coverage, and sponsor oversight
Portfolio Risk
Portfolio & Regulatory · Cross-Study RBQM Roll-Up
ICH E6(R3) · Risk-Based Monitoring
RBQM Dashboard
Live KRI scoring, site risk signals, centralized monitoring activities, and monitoring report generation.
Study Comparison
Side-by-Side Study Diff
Compare systems, integrations, KPIs, and KRIs between any two studies.
Governance & Compliance
Audit Trail
Tamper-evident activity log (demonstration) of system actions, data changes, and governance events across all study sites. Not a validated 21 CFR Part 11 record.
Timestamp User Action Entity Type Entity ID Change Summary Severity Reg. Impact
Report Library
Report Library
Report templates, slide decks, and scheduled reports. Live interactive dashboards now live in Self-Service Analytics.
Data Transfers
Interface Specifications
Enterprise integration architecture — 16 data transfer specifications across 5 tracks. Click any spec to expand full technical details.
Data & Integrations
Connect a System
Guided onboarding to bring data from your existing clinical stack into TrialArchitect — pick a source, test, schedule, and let it flow through the canonical model into reconciliation.
Data & Integrations
Data Intake Monitor
Health, freshness, and error visibility for every inbound data feed — connector status, scheduled loops, and the dead-letter queue with one-click replay.
Data & Integrations
Unified Data Lakehouse
The clinical data lakehouse — browse every integrated source on one canonical model, join across entities on shared keys, and export. Blinding-aware and fail-closed.
Intelligence
🔭 Trial Twin
One twin, two modes. Model a strategic decision during the trial or a protocol-design choice before it — then log any scenario to the Calibration Ledger so its projection is measured against the real outcome. Calibration-grade, transparent, non-binding.
Intelligence
🔮 Decision Twin
Model a decision before you make it. Pull levers — add sites, tighten eligibility, change monitoring intensity, extend follow-up — and see the projected impact on timeline, enrolment, quality, risk, and cost vs. the current baseline, with confidence bands. Calibration-grade what-if, fully transparent.
Intelligence
🎯 Calibration Ledger
Predictions, measured against reality. Every committed projection — decision-twin and protocol-design scenarios, remediation impact, enrolment and database-lock forecasts — is recorded with its confidence band, then reconciled against the actual outcome to produce a transparent, inspector-visible accuracy record and a calibration grade. Calibration-grade until a real outcome feed.
Intelligence
🧬 Protocol Design Twin
Model the protocol before you lock it. Pull design levers — eligibility breadth, visit density, procedures, endpoints, follow-up, planned sites — and see feasibility, enrolment pace, patient burden and cost move vs. your current design, calibrated on your own similar trials. Design out the expensive amendment before it costs you.
Data Governance
🔧 Remediation Console
Oversight that fixes, not just flags. Turn a reconciliation finding into a governed remediation — proposed, human-attested, executed, then verified by re-reconciliation. Auto-execution is limited to reversible, low-risk, in-app actions; an irreversible source-system write-back is e-signature-gated and connector-gated.
Intelligence
🤖 Agentic AI Watchdog
An oversight plane over every AI agent in your trial stack — TrialArchitect’s own agentic layer and third-party agents in integrated systems. Each action is evaluated against autonomy policy, open reconciliation, blinding, and anomaly rules; what matters is flagged for a human. It watches and flags — it never acts on or blocks the agents it observes.
Monitoring & Risk
🏅 E6(R3) Program
Your turnkey Risk-Based Quality Management program for the now-mandatory ICH E6(R3): a live readiness posture across the 90-item matrix, your risk assessment, KRIs and monitoring plan — with a guided setup and a one-click, priors-informed RBQM plan.
Inspection Readiness
🕵 Inspection Copilot
An always-on mock inspection. The copilot walks your reconciled data as the selected inspector persona would, surfaces the likely findings, and drafts a grounded response plus a remediation for each — every draft reviewed and attested by a human before use.
Data & Integrations
🧪 UAT Assistant
Ingest a system's requirements document, generate test scripts, and (in later phases) let an agentic runner conduct the UAT per role while a human monitors progress and findings. Every artifact is a draft for human review; execution runs in test environments only.
Connect · Data Transfers
Transfer Console
Run an integration data transfer through its connector adapter (fetch → transform → push) and review the transfer report. Adapters default to a synthetic mock until live vendor adapters are configured.
Connect · Data Standards
Data Standards (CDISC)
SDTM domains and ADaM datasets this study requires, derived from its selected systems, with a downloadable Define-XML 2.1 specification. Planning specification only — no subject-level data.
Oversee · Inspection Readiness
Controls Readiness
Technical inspection-readiness scorecard for the active study — access control, e-signatures, audit integrity, data standards, and validation — scored from the live system posture. Indicative; not a substitute for a qualified assessment.
Oversee · Governance
Signature Queue
Governance actions awaiting your electronic signature for the active study, and recently applied signatures. Signing re-authenticates and records a bound, tamper-evident signature.
Oversee · Quality
Change Control
In-app CCB workflow (SOP-CHG-001): submit a change request → CCB decision (e-signed approve/reject) → mark implemented. Every step is recorded on the tamper-evident audit trail.
Connect · Integration Command
Integration Command
Your complete connectivity layer — live health, integration architecture, MCP connectors, and data specifications.
Model Context Protocol
MCP Connectors
AI-accessible system connections for the TrialArchitect assistant — real-time data access via Model Context Protocol
Quality & Risk Management
Compliance Scoring Engine
Weighted compliance scores across audit, signatures, SLA, RBQM, integration reliability, and inspection readiness
Regulatory & Quality
Inspection Readiness Center
FDA/EMA inspection readiness command center — audit completeness, eTMF status, signatures, CAPAs, and regulatory submissions
Regulatory Compliance
AI Governance
Traceability, explainability, and compliance audit for all AI-generated recommendations and actions
Operational Intelligence
AI Insights
TrialArchitect AI recommendations — review, approve, or reject with full audit trail
RBQM · ICH E6(R3) · Protocol Intelligence
Protocol Intel
Upload your protocol document to enable AI-assisted KRI and QTL extraction for your RBQM plan
Quality · GCP Compliance · ICH E6(R3) · FDA Draft Guidance 2024
Protocol Deviation Management
Deviation intake, classification, CAPA management, and regulatory reporting
Agentic AI · Autonomous Monitoring · Multi-Agent Orchestration
Agentic Monitoring Workflows
Dispatch specialized AI agents for autonomous clinical operations monitoring — RBQM, safety/PV, data management, regulatory, integration, and clinical ops domains
Regulatory Intelligence · FDA · EMA · ICH · MHRA
Regulatory Intelligence Feed
Curated FDA, EMA, ICH, and MHRA guidance updates ranked by relevance to the active study's phase, therapeutic area, and selected systems
Advanced AI & Analytics · Phase 7
🔮 Predictive Intelligence
Enrollment forecasting, protocol deviation pattern detection, integration anomaly detection, and industry benchmarking
Operational Intelligence
Operations Command Center
Real-time operational visibility across systems, integrations, enrollment, and compliance
Cross-Platform · Notifications · Alerts
Unified Inbox
Aggregated alerts, notifications, and action items from all connected systems — safety signals, data queries, KRI breaches, regulatory deadlines, and integration events
Help Center · AI-Assisted Support · Bug Reporting
Help & Support
Get AI-assisted answers, report a bug, ask a question, or request a feature. Reports are pre-filled into an email to the TrialArchitect support team, with key diagnostics auto-captured to speed up triage.
Support · Ticket Triage · Escalation
Support Inbox
Every Help & Support report, stored in-app with the reporter's contact. Triage, resolve, or escalate to a change-capable role.
Access Control · RBAC / ABAC
User Management
Manage platform users, roles, and study access. Role and access changes are recorded to the audit trail.
Orchestration Engine
Workflow Orchestration
Clinical trial workflow templates — trigger, trace, and audit multi-system operational cascades
Clinical Operations · Subject Registry
Subjects
A per-subject registry for the active study — enrolment, status, visit schedule adherence, AE/SAE, ePRO and linked deviations.
🔗 Ingested data — sourced from EDC / CTMS via integration. Read-only mirror · subject-level data.
Clinical Operations · Subject-Level Risk Intelligence
Subject Intelligence
Per-subject composite risk scoring across visit adherence, AE trajectory, ePRO compliance, deviation history, site tier, and protocol-constraint proximity. Triage before signals become deviations.
Diversity & Inclusion · FDA 2023 Diversity Action Plan
DEI Enrollment Dashboard
Demographic breakdown, DEI KPIs vs. FDA Diversity Action Plan targets, and site-level inclusion performance
Data Management · ICH E6(R2) · Database Lock Governance
DBL Readiness
Pre-database-lock checklist — query closure, SAE reconciliation, coding, e-signatures, and site-level readiness status
Vendor Management · ICH E6(R3) Oversight
CRO & Vendor Comparison Engine
Vendor comparison matrix, CRO performance scorecard, deliverable tracking, and documented oversight per ICH E6(R3)
Protocol-as-Code · Machine-Readable Configuration
</> Protocol Schema
Export study configuration as structured JSON or YAML, import from code, browse version snapshots, and diff changes over time
Interoperability · 21st Century Cures Act
HL7 FHIR Mapping
Study entity → FHIR R4 resource mapping, US Core/mCODE profile compliance, and EMR integration readiness assessment
Protocol Management · Change Control
Protocol Amendment Tracker
Amendment version history, subject impact assessment, re-consent triggers, site notification status, and regulatory submission tracking
GCP Records Management · 21 CFR Part 11 · ICH E6(R3)
Retention Schedule Manager
Document retention schedules by category and regulatory region — with automated expiry tracking, alert thresholds, and legal hold integration per the DIA Framework for Destruction of Paper v2.0
GCP Records Management · Legal & Compliance
Legal Hold Management
Suspend normal retention schedules during litigation or regulatory investigation — with dual eSignature authorization, custodian notification, hold scope management, and complete hold lifecycle audit trail
GCP Records Management · 21 CFR Part 11 · EU Annex 11
ECMS Validation & Certified Copy
Electronic Content Management System validation status tracking, certified copy attestation workflow, and records destruction authorization — pre-requisites for lawful paper records destruction
Protocol Document · ICH M11 · CTD Module 5
Protocol Document
Full clinical trial protocol with all ICH M11 / FDA / EMA required fields. Upload a Word or PDF document to auto-populate via AI extraction, or enter fields manually.
Patient-Centered · BRAT Methodology · PrOACT-URL · PFDD
Benefit-Risk Assessment Framework
Structured benefit-risk evaluation using the BRAT value tree methodology and PrOACT-URL framework — aligned to FDA/EMA regulatory benefit-risk guidance and PFDD meeting outcomes
Patient-Centered · PRO · ClinRO · ObsRO · PerfO · ePRO
PRO & COA Library
Patient-Reported Outcome and Clinical Outcome Assessment instruments — validation status, MCID values, ePRO configuration, and FDA/EMA PRO guidance alignment per study protocol
Regulatory Affairs · DIA RIM V2.0
HA Interaction Tracker
Health Authority meetings, open commitments, and regulatory correspondence — aligned to the DIA Regulatory Information Management Reference Model V2.0
Connect · Data Quality Intelligence
Data Observability
Schema drift detection, missingness anomalies, ingestion latency, and per-connector trust scores — the data quality layer beneath every KRI
Data Governance · Continuous Oversight
Real-Time Reconciliation Monitor
Continuous cross-system reconciliation polling — 60-second cadence over connected systems with auto-routing of findings to the assigned Data Custodian by domain
Data Governance · Lock Management
Data Lock Manager
Soft, interim, and final data locks — gate-checked against reconciliation/SDV/query closure, eSignature-attested under 21 CFR Part 11, immutable snapshot captured at commit
Data Governance · Accountability
Data Custodians
Named owners per data domain — reconciliation findings, lock gate failures, and quality alerts auto-route to the assigned custodian with escalation chain
Data Governance · DMC Workflow
DMC Meetings & Decisions
Data Monitoring Committee meetings — member roster with COI tracking, agenda/minutes generation, recommendation capture (continue / modify / pause / stop) with auto-chain into amendments
Data Governance · Document Generation
Governance Documents
Generate Data Management Plan, DMC Charter, DMC meeting minutes, and reference the controlling SOP library — all from live study state with eSignature lock
Data Governance · Administration
Roles & Permissions Guide
Reference catalog of platform roles, permissions, study scope, and elevation rules. Admin-and-above visibility. CRO Admin sponsor associations are managed here by Super User / Sub-Super User.
Data Governance · External Transparency
Public Data Quality Attestation
Quarterly auto-generated attestation summarising data quality state — reconciliation, locks, DMC oversight, audit evidence. Sponsor-signed under Part 11 eSignature. Public share URL for sites, vendors, and the public.
Clinical Operations · Site-facing
Site Inbox
Sponsor-branded per-site aggregation of every pending action — reconciliation findings, deviations, queries, monitoring visits, CAPAs, training. Delivered through the sponsor's existing site channel; no new site credentials required.
Connect · Integration Integrity
Cross-System Reconciliation
Detects when your connected systems of record disagree — subject-count, randomised-not-dosed, SAE-without-AE, consent-version drift, consent-after-enrolment, ePRO gaps, overdue-visit-without-data, withdrawn-active drift, duplicate-subject, dispensation-vs-randomisation, and out-of-range-lab-unflagged across EDC · CTMS · IRT · Safety · eConsent · eCOA · Central Lab · Supply Chain
Data Governance · Integration Integrity
Reconciliation Control Tower
A neutral truth layer across your connected systems — confidence-scored discrepancies with root cause, a consistency trend, one-click CAPA, and an inspection-ready ALCOA++ Consistent evidence export.
Oversee · Quality System · GxP
CAPA Management
Corrective and Preventive Actions — auto-drafted from governance signals and KRI breaches, with AI-generated root cause analysis, SLA tracking, and GxP audit trail
Orchestrate · Site Management
Site Roster
Full lifecycle tracking from feasibility through close-out — enrolment progress, risk levels, and investigator details for every site on the active study
🔗 Ingested data — sourced from CTMS via integration. Read-only mirror · site roster & activation.
Notifications
No notifications
🤖
TrialArchitect AI
Hi! I'm the TrialArchitect AI. Ask me about your study's systems, integrations, risks, or regulatory readiness.

Mock Inspection

API Hub

Blinding & Unblinding Control

Central Lab & Biomarker Management

Quality & Compliance · GSN Argument
Assurance Case
A structured Goal Structuring Notation argument that this trial’s data and conduct are trustworthy — each sub-claim bound live to engine-computed evidence. Gaps surface before an inspector finds them.
Quality & Compliance · Economic Twin
Prevented-Harm & Value Ledger
Every platform “catch” — reconciliation discrepancy, KRI signal, closed CAPA, protocol violation — mapped to a counterfactual DBL-day and indicative cost-avoided figure. The economic twin of the Assurance Case.
Monitoring & Risk · Query Lifecycle Intelligence
Query Intelligence
Predict → prevent → draft → database-lock impact. The query layer is the largest hidden monitoring cost in a trial — QLI surfaces the forms and sites about to generate the next wave of queries, the targeted prevention action for each, and the DBL-day exposure of the aged backlog.
Monitoring & Risk · Site Risk Intelligence
Site Risk Intelligence
One composite risk score per site, synthesizing five behavioral drivers — KRI status (30%), investigator engagement (25%), query burden (20%), open deviations (15%) and visit effectiveness (10%). The portfolio heat map ranks every site across every study; the per-site breakdown shows exactly which driver is pushing each site up the curve, so the right lever is obvious before a KRI ever breaches.
Monitoring & Risk · Site Forecast & Readiness
Site Forecast & Readiness
Where Site Risk Intelligence scores a site’s risk today, SFR projects where it is heading. Each site gets an enrollment-completion forecast from recent velocity, a database-lock readiness score with the concrete blockers to clear, and a 30/60/90-day SRI trajectory that flags tier breaches before they happen — turning reactive escalation into proactive, scheduled intervention.
ICH E6(R3) · GCP Compliance Assessment
Compliance Framework
Real-time ICH E6(R3) compliance status derived from live study data. eSignature-gated quarterly attestation.
ICH E6(R3) · FMEA Risk Assessment
Risk Register
Study risk inventory with likelihood × impact scoring, mitigation tracking, and approval workflow.
ICH E6(R3) §5.18 · Risk-Based Monitoring
Monitoring Plan
Per-site SDV strategy, visit frequency by risk tier, and eSignature-gated plan lock.
ICH E6(R3) §5.0 · Centralised Statistical Monitoring
Central Statistical Monitoring Plan
A controlled document — distinct from the operational Central Monitoring dashboard. Upload an existing plan, generate with AI, then export to PDF or Word.
ICH E6(R3) §5.18 · Subject Visit Oversight
Subject Visits
Per-subject protocol visit completion and window compliance — the visit data that drives KRI and central-monitoring signals.
ICH E6(R3) §5.18 · Site Monitoring Visits
Site Visits
On-site and remote monitoring visit cadence per site, with overdue tracking.
ICH E6(R3) §5.18 · Remote Data Review
Central Monitoring
Remote data review listings, query management, monitoring visit log, and cross-site outlier detection.
RBQM · Site Risk Intelligence
Site Performance
Per-site scorecards derived from real enrollment, deviation, KRI, and monitoring visit data.
Signal Intelligence
RBQM & Monitoring
Autonomous SDV
Monitoring & Risk · Source Data Verification
Notifications
RBQM & Monitoring · Real-Time Alerting
SAE/SUSAR Watchtower
Monitoring & Risk · Continuous Safety Surveillance
Why Explorer
Intelligence · Explainable Root-Cause Tracing
Insight Stream
Intelligence · Auto-Generated Cross-Engine Insights
Risk Convergence
Intelligence · Where Independent Risks Stack Up
RBQM Reports
RBQM & Monitoring · Quarterly · DSMC · Statistical · ICH Evidence