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Site performance profile

What the portal measured of a site in your studies, the sites side by side, the site's consent.

Choosing sites for a new study usually starts with a feasibility questionnaire: the site says how many patients it can enrol and how fast. Site performance shows what the portal measured instead: how the site actually worked in your organisation’s studies. The numbers come from the studies themselves, from the same counts their pages show, and are counted again each time you open the profile; nothing is typed by hand.

From the studies to the site’s profile T2D-301 · site 03 24 patients, 410 pages HTN-202 · site 11 18 patients, 260 pages University Clinic 2.1 patients per month entry delay 3 days 1.4 queries per 10 pages patients kept 93 % no number of a person your team always a sponsor with consent The counts of each study are added together first, then each number is worked out once, so a number of one study and of all of them follow the same rule. A number counted on fewer than 5 patients or pages is underlined in grey: read it with care.
One directory card, two studies: the site’s profile is the sum of what it did in both.

The numbers

  • Patients per month: enrolled patients divided by the months of enrolment, from the site’s activation (kept in YouEDC Trials, else its first patient) to its last patient once enrolment is closed, or to today while it is open.
  • Days from activation to the first patient: the median over the studies whose activation day is kept in YouEDC Trials.
  • Entry delay and pages entered late: days from the visit to the first save of each page typed at the site, as in the data quality report; late means more than 30 days.
  • Queries per 10 pages and days to answer a query: as in the site risk (RBQM), the answer counted from the query to the site’s first answer.
  • Patients kept: the share neither withdrawn nor lost to follow-up; patients who withdrew the use of their data are left out.
  • Monitor’s queries per 10 verified pages: what source data verification found, the monitor’s queries against the pages verified in the study’s SDV scope.
  • Deviations and important deviations per 10 patients: from the deviations log of YouEDC Trials. A study that keeps no log here shows “—”, not zero.

These are counts of pages, queries and dates, never values: a blinded study shows the same numbers to everyone, and nothing about a patient leaves the study.

A site’s profile and the comparison

The profile is on the site’s card in the directory (Site directory → the site → Performance in your studies): the numbers of all the organisation’s studies that use the card, and a line per study you work in. A colleague who is not in a study sees it in the sums, without its own line. Site performance in the menu shows every site of the directory side by side; click a column to sort the sites by it, the best first. Excel downloads the same table for the organisation.

Not a rating of doctors

The profile belongs to the site, a hospital department, not to a person. There is no number per investigator or per member of the team: that would be their personal data. The principal investigator’s name is in no page or file of the profile. The site directory itself keeps no people either.

Showing it to a sponsor: the site’s consent

Inside the organisation its people see every profile. Outside it, a profile goes only with the site’s consent: the site agrees in a letter or a clause of the contract, and an admin of the organisation records it on the card (Consent to show the profile outside the organisation: the day and the document). For a sponsor on the Site performance page downloads a file with only the sites that agreed, and says so. A site may withdraw its consent: record the withdrawal, and its profile leaves the file from that moment. Every consent, withdrawal and download is in the audit trail.

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