Seven sections: YouEDC Capture, YouEDC Studio, YouEDC Safety, YouEDC Sites, YouEDC Trials, YouEDC Supply, YouEDC Biostat
What lives where and how to switch.
The YouEDC portal has seven sections on a shared base: YouEDC Capture, YouEDC Studio, YouEDC Safety, YouEDC Sites, YouEDC Trials, YouEDC Supply and YouEDC Biostat. They look different on purpose: YouEDC Capture is marked red, YouEDC Studio blue, YouEDC Safety purple, YouEDC Sites teal, YouEDC Trials terracotta, YouEDC Biostat raspberry, YouEDC Supply green. The section names are the same in every language.
YouEDC Capture: your own studies
A data capture system for your own studies: registries, observational and retrospective studies, patient surveys. Everything YouEDC 0.2 did is here: eCRF builder with edit checks, patients and the visit matrix, data entry, queries, SDV, ePRO by link, CSV and Excel import, exports to Excel, CSV and CDISC ODM 1.3.2. Plus sites, a team with roles, invitations and an audit trail with integrity checks.
YouEDC Studio: data from other systems
Data-management work on studies that run in other systems: MainEDC first of all, as well as Veeva Vault, Rave, InForm and others. Each such study is a DM project with its team, task list and tools; next to them are tools that work on a single uploaded file: profiler, export comparison, query report, reconciliation, data review and others.
YouEDC Safety: pharmacovigilance
The section for the pharmacovigilance team and the sponsor: a queue of serious adverse event cases of every study, intake, Day 0, SUSAR rules, 7- and 15-day deadlines, narrative, discussion and e-signature of a case, the CIOMS I form and an E2B(R3) export. Serious AEs from YouEDC Capture forms arrive by themselves; SAE listings of other EDCs are uploaded. Submission to the authorities stays manual for now.
YouEDC Sites: the master file
The trial and site master file (eTMF prototype): records by TMF Reference Model zones, versions, quality control, expiry dates. Each site has its page: what is missing and what the team asked the doctor for by e-mail. Go-live, database lock and the YouEDC Capture data for the sites reach the master file by themselves. The YouEDC Sites tab shows the master files of all your projects; inside a project it is the menu item “Trial Master File”. Next: investigator dossiers and the site profile.
YouEDC Trials: running the study
A simple clinical trial management system (CTMS) for monitors and the project administrator: site statuses and activation steps, the enrolment plan and fact, monitoring visits with a report under two signatures and a letter to the site, action items with dates and the protocol deviations log. The sites' numbers come from YouEDC Capture by themselves. The YouEDC Trials tab opens the monitor's desk across all your studies; inside a study it is the “YouEDC Trials” menu item. More in the article YouEDC Trials.
YouEDC Supply: the drug supply
The study drug from the depot to the patient: kit types by arm, batches released by a second person, the kit list, shipments and receipt kit by kit, temperature in transit and quarantine, site resupply by a trigger level and the visit forecast. The “Dispense a kit” button sits right in the visit form, and the doctor sees the site's stock. In a blinded study the blinded team sees kit numbers only. The YouEDC Supply tab shows the supply of all your studies; inside a study it is the “YouEDC Supply” menu item. More in the article YouEDC Supply.
YouEDC Biostat: the statistics of the study
Descriptive statistics of every YouEDC Capture study, counted by themselves from the live data: enrolment, taking part, age and sex, Table 1, the key variables over the visits and their change from baseline, adverse events and safety variables, by arm for readers who may see the arms, and a PDF report. The YouEDC Biostat tab lists your studies; inside a study it is the “YouEDC Biostat” menu item. More in the article YouEDC Biostat.
Switching
Section tabs at the top of the left menu: YouEDC Capture, YouEDC Studio, YouEDC Safety, YouEDC Sites, YouEDC Trials, YouEDC Supply and YouEDC Biostat. The current section is named in the top bar. If a Portal Owner turns a section off, its tab disappears. The YouEDC Sites tab gathers the master files of all your projects: how complete each is, what is missing, expired or waiting for QC; the master file itself is kept inside the project, the “Trial Master File” item of the project menu.
Collapse the left menu
In large tables and grids (patients, queries, reconciliations, reports) you can collapse the menu. The button with a panel icon sits to the right of the logo at the top of the menu. The collapsed menu becomes a narrow strip of icons: sections are coloured squares, the project is its avatar, items are icons, and the number of open queries stays on its icon. Point at an icon and its name appears next to it; the same happens when you move with the Tab key. To bring the menu back, click the same button at the top of the strip. After you open an item from the lower part of a long menu, that item stands at the top edge of the menu, so you do not scroll down again; if the item is visible in the first screen of the menu anyway, the menu does not move.
The choice is remembered for your account: the menu stays collapsed on every page, after signing out and on another computer until you expand it yourself. The menu never collapses on its own. On a phone or a narrow screen nothing changes: the ☰ button opens the menu and the cross closes it.
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