What this is, and who it is for
Trialion answers the question "how is the study going?" in two places: the dashboard of a workspace (a set of figures arranged in five tabs) and six reports with a page each. All of them read the study's own records, in the workspace you are in: Live figures are real data, UAT figures are test data, and the two never mix. A report that needs a record you may not see leaves it out and says so.
| You need | To |
|---|---|
study.read | See the dashboard and the Lock readiness report |
subject.read | The Enrollment report |
site.read | Site performance and Visit compliance |
clinical.query.read | Query aging and Protocol deviations |
Held by: Organization Admin, Project Manager, eCRF Designer, Clinical Research Associate, Data Manager, Medical Officer, Sponsor Manager, Sponsor Supply Manager, Auditor, Principal Investigator, Clinical Research Coordinator, Pharmacy, Site Monitor, Clinical Data Coordinator, Regulatory Manager (study.read).
Where to find it
In a workspace: Dashboard (the workspace home) and, under the reports, Enrollment, Site performance, Query aging, Visit compliance, Protocol deviations and Lock readiness. The study's Overview (at the study level) summarizes the study; the Studies home lists every study you work on with its main totals.
What you can do
The dashboard
Five tabs:
| Tab | What it shows |
|---|---|
| Recruitment | Weekly enrollment against a target pace, the screening funnel (screened, screen failed, withdrawn, randomization failed, in screening, on study) and recruitment by site; the balance between arms |
| Data quality | Query throughput over the last 30 days (raised, closed, net change, median resolution), aging and priority of open queries, where queries come from (automated or manual), data entry (forms entered, complete, in progress, not started, awaiting entry, median lag) and source verification |
| Sites & visits | Active, in start-up, suspended and newly activated sites; Site risk (the worst sites first); Visit adherence (visits due, captured, missed, out of window, in window now, upcoming in 14 days) |
| Safety & compliance | Serious adverse events (total, report pending, overdue, next deadline), protocol deviations (open, in review, reportable, resolved), signatures (total and last 30 days) and recent exports |
| Protocol & team | The protocol, milestones, the design versions (the Live version and the environment), the study team and recent activity |
Banners at the top call out what needs attention now: N SAE reports are past the reporting deadline, N SAE reports awaiting submission, N queries are past SLA.
The reports
| Report | Question it answers | Notes |
|---|---|---|
| Enrollment | How is recruitment going? | Enrolled and screened in the last 90 days, screen-failure rate, withdrawals, weekly enrollment for 13 weeks, the funnel |
| Site performance | Where does each site stand? | By site: enrolled against target, progress, screen-fail rate, visit compliance, entry lag, open queries, SDV verified, a risk rating, sorted by risk. Needs attention lists sites below 80 % visit compliance, past a query SLA or at high risk; enrollment by country against its share of target. Download CSV and Print. A site target is set on its page |
| Query aging | How long have queries been open? | Open queries by age, how many are past their SLA |
| Visit compliance | Are visits happening in window? | In-window, out-of-window and missed visits |
| Protocol deviations | What is going wrong against the protocol? | By severity, status and category, weekly trend for 13 weeks, reportable ones, average days open; study-level and per site (Report a deviation) |
| Lock readiness | What stands between the study and a database lock? | Seven conditions, each with a count and the sites it sits at |
Lock readiness
The report shows the seven conditions that matter before a lock, with a link to act on each: Open queries (with how many are past SLA and the median age), Forms not complete, Awaiting investigator signature, Source data not verified, Visits due, not captured, Deviations and Safety. It reports; locking is requested and confirmed by two people from the study's state menu (Close and lock a study). Download CSV and Print are on the page.
Every option
Period and freshness
Reports with a Period use a fixed window (90 days, 13 weeks); the header shows when the figures were Updated or As of. Figures come from the summary tables the platform keeps, rebuilt from the records; the operator is alerted if they lag or disagree with the records (Running it).
Who sees what
A site person sees their own site; a study-level role sees all sites of the study and workspace; blinding is not applied (the arm balance is visible to anyone who may read participants: Not built yet).
What the system records
Reading a report leaves no record: the audit trail records changes and refusals, not reads, and a report's CSV is made in the browser from the figures on the screen. See Audit events.
What you cannot do, and why
- Compare UAT and Live in one view. They are separate by construction.
- Edit a figure. Every figure is derived.
- Get a cross-study report. Each report is of one study; the Studies home totals are the only cross-study view.
- Receive a report by e-mail. Reports are not scheduled or sent.
Compliance Q&A
Yes. The dashboard and the six reports are derived from the records, queries, verifications and safety trail; the lock readiness report counts the same things the lock request lists.
Limits: there are no key risk indicators, central statistical monitoring or data review listings across participants (Not built yet).
Evidence: server/src/modules/study/dashboard, reports (derived from records on read or from summary tables)client report screens
Related
Use the casebook · Close and lock a study · Monitor and verify data · Work with queries · Sponsor Manager