YouEDC Studio

Study metrics

What each metric counts, where the data comes from and the lists behind the numbers.

“Metrics” is the first section of YouEDC Studio. It shows how a study goes from the data's point of view: enrolment, visits and data entry lag, data cleaning and SDV, queries, data changes and adverse events. Every number can be clicked: it opens the list of patients and records it was counted from.

Where the data comes from

  • A YouEDC Capture study. The metrics are counted on the live data of the study, with nothing to export. You see what the study export would give you: only your sites, the forms of the unblinded team hidden. The audit trail (for the data changes) leaves out the forms hidden from you as well.
  • A DM project (data from another EDC). The metrics are counted on the newest delivery of the Project data page. Any other delivery can be chosen in the “Data” list.

The tables of an export are recognised by their columns: patients, visits with dates, page status, queries, the audit trail, adverse events. Exports of Rave, InForm, Vault, Viedoc, REDCap, Castor, MainEDC and CDASH/SDTM fit, Russian headers too. “What was read” at the bottom of the page shows how each table was recognised. A metric the data does not allow stays grey and says which listing it needs.

How the screen is built

  • At the top are the filters: the data (live or a delivery), the site and the length of the charts (12, 26 or 52 weeks).
  • Below are the eight top numbers. Each shows the change since the delivery before (in Capture, since the newest snapshot) and a small weekly chart. Green means better, red means worse.
  • Then the metrics come in groups: patients and enrolment, visits and data entry, data cleaning, queries, data changes, safety. Each group has its list of numbers, weekly charts and bars of distributions.
  • “Sites side by side” compares the sites on the main numbers. A cell is red when the site is clearly worse than the study as a whole and green when clearly better. Click a column title to sort.
  • “From delivery to delivery” shows the top numbers of each delivery or snapshot next to the live data.

The lists behind the numbers

A click on a number, a bar or a cell of the table opens the records behind it: patients, visits, pages, queries, changes or AEs, with their days. In a Capture study a patient's number opens their card and a query's number the patient's queries. Every list downloads to Excel. The “Excel” button of the metrics page downloads all the metrics with their rules, the site table and the weekly series.

How each metric is counted

Each metric has a “?” with its rule. The main rules:

  • Data entry lag: days from the visit date to the first entry of the page (from the audit trail or the entry date of the page listing). The median and the slowest 10% are shown. A page is late when its lag is over 7 days.
  • Silent patients: patients on study (not completed, not withdrawn) with no visit for more than 60 days.
  • Clean patients: every page complete or verified, no open or answered query.
  • Query age: days from raising the query to the data date. The data date is the latest date in the data, never later than today.
  • Change rate: changes of values already entered divided by first entries.

Metrics of all your studies

“Metrics” in the YouEDC Studio menu opens all your studies on one screen: Capture studies on their live data, DM projects on their newest delivery. The studies that need attention come first. Red means queries older than 30 days pile up or data entry takes over two weeks. Amber means old queries, slow entry, silent patients or many incomplete pages.

The top numbers of all the studies come first, the list under them: the traffic light, where the data comes from and what needs attention. Each reason (old queries, slow entry, silent patients, incomplete pages) opens its list. The list shows at once, and each study fills its row as soon as it is counted. There is no need to wait for every study: any of them opens with a click on its code. Inside a YouEDC Capture study the YouEDC Studio tab opens its metrics straight away, and the “All studies” button of the metrics page leads back to the overview.

Rights and personal data. The metrics open for the project manager and the data managers: those who may work with the study's data. Nothing is stored on the portal, the numbers are counted when the page opens. An Excel download goes to the project's audit trail.