Study status report on a schedule

What goes in the weekly or monthly report for the sponsor, who gets the letter, what each reader sees, the Excel and PDF, and how to show what was sent.

The sponsor and the team want to see the study in numbers every week or month: how recruitment goes at each site against its target, which visits are overdue, how many pages are missing, how old the queries are, how far SDV has come. The Status report page makes this report on a schedule, keeps every report with its checksum and tells the chosen members of the team by e-mail that it is ready. You can also download it at any moment, without a schedule.

The Status report page: tiles with the schedule, the next report, the recipients and the reports kept; the list of kept reports with Open, Excel and PDF; the Download now card with the period and the Excel and PDF buttons — The **Status report** page of the demo study: two weekly reports kept, and “download now”.

What goes in

Recruitment by site: the target of each site, the patients registered, randomised, screening failures (patients who left before randomisation), taking part, completed, withdrawn or lost and died; new in the period. Arms only for an unblinded reader.
Visits: done in the period, overdue now, did not take place.
Form completion and missing pages: complete forms among those expected so far, drafts, pages missing after the visit window closed.
Queries: open, answered and closed by site; the age of the queries not closed (up to 7, 8–14, 15–30 days and older); opened and closed in the period; the average days to the site's first answer.
SDV progress, and the data manager's approval when the study uses it.
Coding backlog: terms waiting for a code, when the study codes in YouEDC.
Lock readiness: the readiness score, the blockers and the forecast date of the lock, when the study keeps the lock readiness checklist. Only in the copies for all sites.
ePRO compliance: questionnaires sent by the patients among those due, when the study has forms for the patient.
Patient-level lists: overdue visits and queries older than 30 days by patient code. Only on the portal and in the files, only for readers who see patients.

Patients who withdrew the use of their data are counted only in the recruitment.

The schedule and the letter

The data manager and the project manager set the report up in What goes in, when and to whom; every change of the settings is in the audit trail of the study.

The settings: how often, the weekday, the day of the month, the period, the files; the sections with ticks; the members of the team with their sites and view — The settings: the schedule, the sections and the recipients from the team.

How often: weekly on a weekday, monthly on a day from 1 to 28, or off (then only “download now”). The report is made from 08:00 on that day.
Period of a scheduled report: the 7 or 14 days before, the month before, or everything since the previous report. What changed is counted over the period (new patients, closed queries); what stands is counted as of that day (overdue visits, open queries, complete forms).
What goes in: tick the sections. Files for the readers: Excel, PDF or both.
Who gets the letter: tick members of the study team. Only the team: e-mail addresses cannot be typed. Under each name you see what the person will get: their sites, the blinded or unblinded view, with patient lists or numbers only.

The letter carries no personal data and no file: only the numbers of the reader's own view (patients, overdue visits, missing pages, open queries, SDV) and a link to the report on the portal, which needs signing in. Each person reads it in their own language and can switch it off in the profile. A member who left the team or lost the right to see reports gets nothing. The QA environment, demo studies and studies before the launch send no letters; the reports are still made and kept.

What each reader sees

A member limited to some sites sees only those sites, in the letter, on the page and in the files.
A blinded member sees no arms and nothing of the forms for the unblinded team.
Patient codes appear only on the portal and in the files, and only for readers who are allowed to see patients. The letter never has them.

For this the portal keeps a copy of each report for each view: the team's full copy and one for each reader's view. A reader opens only the copies their rights cover.

One report, the files and the evidence

Status report No. 2: the study, the period, the date of the numbers, the sites and view of the copy, its SHA-256; the headline tiles; the recruitment table by site — A kept report: the copy's view, its SHA-256, the tiles and the recruitment by site.

Open shows the report as it was made: the numbers of that day, not of today. The page lists the first 20 rows of each patient list; Excel has up to 300 rows of each.
Excel has a sheet per section; PDF is an A4 page with the SHA-256 of the copy in the footer.
Each copy is kept with its date, period and SHA-256 and cannot be changed. If the stored data no longer matches its checksum, the portal refuses to show it.
The data manager and the project manager see under the report who got a letter, of which copy, and can open each letter as it looked.
Making a report, each copy and each letter are records in the audit trail of the study.

Download now

Everyone who sees the reports can choose a period in Download now and press Excel, PDF or Show on the page. The report uses the numbers of today, is made for the reader's own view and is kept in the list like the scheduled ones.