Study overview and settings

Set-up steps, launch, lock, blinding.

Who created the study

Under the study name you always see who created it and when: “Created by name · date and time”. The Portal Owner also sees the creator's e-mail and organisation. A demo project names the person who generated the demo and the real time, even when its invented data history starts earlier. The time is shown in the time zone of your computer or phone with the zone written next to it, e.g. “09.10.2026 19:22 UTC+3”; hover over it for the zone's full name. The line is the same on a YouEDC Capture study overview and on a YouEDC Studio project.

The “Created by” line under the study name — The study's creator and creation date under its name, as a Portal Owner sees it: with e-mail and organisation.

Name and identifier

Every study has a permanent identifier: the code given when it was created, e.g. DEMO-DOG. It never changes: the study's address, exports, documents and the audit trail rely on it. So the identifier always stands in brackets next to the name: “Osteoarthritis in dogs (DEMO-DOG)”. That is how the study is named in the overview header, the patient casebook, the biostatistics PDF, the visit note, the DM documents, the validation package, the site's ISF, the README of exports and invitation letters.

The study manager or a Portal Owner changes the name freely: “Rename” next to the name on the overview, or the “Name” field in the settings. The study can be renamed at any stage, after the database lock too, because the name is not study data; an archived project is restored first. Every rename goes to the audit trail: the old name, the new one, who and when. The study's QA environment is renamed with it while its name is the same as the study's, and that is recorded in its own audit trail.

Set-up steps

While the study is being set up, its overview shows the launch plan: describe the study, add the sites, invite the team, build the eCRF, try it on a test patient, launch. Finished steps tick themselves. See the launch checklist.

Statuses

A study goes from set-up to enrolment and, at the end, to a locked database.

Setting up: everything can change. Patients enrolled now are test patients.
Enrolling: the study is launched and the launch date is in the audit trail. At the launch, test patients can be deleted together with their data.
Enrolment closed, Soft lock and Database locked: the close-out stages. Each closes a little more, and the manager signs every move with a reason and the password. See Closing a study.

Study numbers

Once the first patient is enrolled, the overview shows the study at a glance:

Patients enrolled: total and against the enrolment target, enrolled this month, active.
Forms complete: complete forms among those expected by today, that is, in visits whose window has started.
Open queries: by age, up to 3 days, 3 to 7 days and older, and how many answers are waiting to be reviewed. Old queries are the first candidates for a reminder to the site.
Visits out of window: the window has closed and there is no data; below, how many windows close within 7 days.
Verified (SDV): the share of complete forms verified by the monitor.

Below come enrolment by month, the latest changes and the sites table: enrolled against target, forms complete, open queries and the last data entry at each site. Investigators and monitors see the numbers of their own sites only. Click a number to open the list behind it, already filtered: “Forms complete” opens the patients with forms not completed, the query age chips open the queries of that age, “Verified (SDV)” the forms waiting for verification, and the numbers in a site’s row that site’s patients and queries. A hint on hover (a tap on a phone) says where a number leads.

The overview of REG-DIAB-01 — The overview of the demo registry REG-DIAB-01: 16 of 300 patients, 92 % of the expected forms complete, 4 open queries, one visit out of window, 50 % verified.

A big study

A registry can grow to tens of thousands of patients. The pages stay fast for that: we check them on a copy of the demo registry with 50 000 patients and 300 sites before every release.

Up to 3 000 patients in your sites every number is counted live; above that the summaries are kept for 10 minutes.

Summaries kept for 10 minutes: the overview, the overdue count in the patient list, the site risk and the data quality report. The first reader counts them, the next ones get them at once. Under the numbers you see “Counted at 14:05”; Count again counts them for you now, for example right after a correction.
What is always live: a patient's pages, the queries, the numbers in the tabs of the patient list and of the review, the signature list.
Lists by pages: patients, review and signatures show 100 rows a page; the filters and search work on the whole study.
Calendar: shows one site at a time; choose the site at the top.
Files: the export and the data cuts are written row by row, several times faster and with little memory; the audit trail CSV starts downloading at once.

Settings

Name, sponsor, target number of subjects, subject number prefix and the “blinded study” flag. In a blinded study team members do not see treatment allocation by default; unblinding is set per person in the team.