YouEDC Capture
- The study overview: “Forms complete” opens the patients with forms not completed, the query age chips the queries of that age, “answers to review” the answered queries, “Verified (SDV)” the forms waiting for verification, the approval line the forms waiting for the data manager. In the sites table the number opens the site's card, enrolment and completeness the site's patients, queries the site's queries Study overview and settings
- The study build is validated in the QA environment: the study's validation package is kept there, its documents describe the eCRF candidate being validated and its UAT, and an infographic on top of the page shows the whole way and where the study stands: the eCRF, the candidate, the UAT, the package approved, the release in production. Production gets the validated version, working at once; nothing is validated in production, and its menu item leads to the package in QA. In production the package is neither made nor signed, also in an older study without a QA environment, whose eCRF builder is read-only until the administrator makes the QA environment. Documents that earlier releases kept in production by mistake move to the study's QA environment once, at the install, with a line in the audit trail; after that production holds no package. While the package is not approved, the release form says so, and such a release goes to the audit trail; the candidate's specification shows which production version it became, with the SHA-256 of both. Validation package · QA environment of a study
- Informed consent: on paper by default, electronic by choice. Every study's consent is now on paper until the project administrator chooses Electronic on the Informed consent page: only then remote signing, the talk with the doctor and the countersignature switch on. Studies that already used eConsent stayed electronic. A paper consent is recorded with the time of signing, who signed (the patient or a legally acceptable representative), whether an impartial witness was present and whether the patient got a copy; the scan of the signed form goes with it, and on withdrawal the scan of the written withdrawal. The scan is named by the patient's code, a photo loses its metadata; only the site team and the project administrator open it (monitors when the study allows the remote check), every view and download is in the audit trail. A wrong scan is withdrawn with a reason and deleted from the server. A consent version carries the approved form itself and the ethics committee's approval, the monitor marks “Checked against the original”, and the tab “No scan” shows who still lacks one. Informed consent · Remote electronic consent
YouEDC Studio
- Study metrics. The first item of YouEDC Studio and the first tile in every study: about 30 numbers in six groups (patients and enrolment, visits and data entry lag, cleaning and SDV, queries, data changes, safety), eight top numbers with the change since the delivery before and a small chart, weekly charts, the sites side by side with the lagging ones marked, and the trend from delivery to delivery. A click on a number opens the patients and records behind it; in a Capture study a patient's number opens their card. Each metric carries its rule, everything downloads to Excel. A Capture study is counted on its live data, a DM project on its newest delivery, with nothing to upload. “Metrics of all your studies” shows every study with a traffic light, those that need attention first Study metrics
YouEDC Safety
- YouEDC Safety as a section of its own: above the queue a row of projects with the number of open cases, a project code there and in the table opens the project's Safety page, a case number the case card. The breadcrumbs of Safety pages stay in the section (YouEDC Safety / project / case) and do not lead to the study's YouEDC Capture pages YouEDC Safety
- Taking back a case already reported. A nullification (a duplicate, not a valid case, sent in error) with its reason and the password closes the case for good; an amended report corrects a version without new information. The platform lists everyone who had the case, with a 15-day deadline, and the E2B of the current version carries C.1.11 YouEDC Safety
- The E2B(R3) check before sending on the Reports tab: mandatory elements, MedDRA codes and version, dates in order, field lengths, a suspect product, the trial's registration number from the study profile, and the official ICH schemas when the server has them. Each finding links to the tab to fix it YouEDC Safety
- The authority's acknowledgement (ACK) is loaded as a file and closes the E2B reports it answers. A refusal (CR, AR) shows in the log of reports with its errors and does not meet the deadline until the report is sent again YouEDC Safety
- The signal log on the project's Signals page. A flagged term becomes a signal in one press (a fatal outcome makes it high priority); a signal can also be raised by hand, from the literature, a partner or an authority. The physician validates or refutes it with the evidence, then closes it with a conclusion (new risk, known risk changed, not confirmed, keep monitoring) and the actions, signed with the password. Starting deadlines: validation in 30 days (7 for a high priority), the conclusion 60 days later. The DSUR draft says how many signals are closed and which are still being evaluated YouEDC Safety
- Priority and step targets in the Safety worklist. Every open case gets a P1-P4 priority: P1 is a fatal or life-threatening (possible) SUSAR, a report due within 2 days or overdue, or a case marked urgent with a reason (an authority's question, a press enquiry); P2 another SUSAR; P3 another serious case; P4 a non-serious one. The step the case is at (data entry, medical review, QC) gets an internal target counted from the start of the clock: by default days 2/4/6 for a 7-day report, 5/10/13 for a 15-day report or a follow-up, 10/20/30 with no expedited report; a project sets its own days for its SOP in the settings. A late step raises the priority one level, one e-mail goes to the assignee and the physicians, and the audit trail records it. The queue is sorted by priority and filters the cases late at a step YouEDC Safety
Portal
- The home page numbers open lists. “Sites” opens the sites of all your studies (those without a principal investigator first, when there are any), “People in my studies” the people (those who never signed in first), “Invitations pending” the invitations not accepted yet, the oldest first. The latest events open the record in the study's audit trail. In the indicators a status opens the studies of that status, a role the people of that role, a phase or an area the portfolio filtered, a tool the tool itself; DM tasks, coding, lock readiness and site risk open the project or the site Sites and team
- A study card in My studies no longer shows a square with the first letters of the code next to the code itself: the study code stands once, beside the stage and environment badges.
- The Portal Owner opens any study, also one whose team they are not in: every page a project administrator sees, read-only, blinded like a member who is not unblinded, and downloads nothing. Each such visit goes to the study's audit trail, and a banner on top says that working in the study needs joining its team. Administration
- Deleting a project: the code field has a clearer label and is no longer filled with an e-mail address the browser saved, each error shows under its own field, and the fields line up. Administration
Improvements and fixes
- The Validation package in the menu of a QA environment no longer leads to “Page not found”: the package is kept right there now.