What’s new
Every release, and everything in it
Each release of YouEDC gets an article: what appeared in YouEDC Capture, YouEDC Studio, YouEDC Safety and YouEDC Sites, with links to the help. The newest is on top.
- Site payments, medical review and data entry without the internet YouEDC Trials accrues site payments by visits from YouEDC Capture data and carries statements from the sponsor's approval to payment, with the budget against actuals. YouEDC Capture has medical review for the medical monitor, outcome adjudication by a committee, biosample tracking with shipments to the laboratory, double data entry from paper CRFs, bulk data change requests, scheduled data delivery with a delta export, data entry without the internet, visit reminders to the patient and a data manager's assistant on the installation's own language model. The public site has the “YouEDC platform” menu and a page on validation. YouEDC Capture · 9YouEDC Trials · 1Portal · 1 Read the article
- Repeating groups of fields, remote SDV and inspectors YouEDC Capture forms have repeating groups of fields, a field can carry a note without a query, and the monitor checks the data remotely by copies of the source documents. An inspector or auditor is invited to a study read-only until a set day, a study manager reviews and signs the access every quarter, and the portal can close accounts nobody signed in to for a long time. YouEDC Capture · 3YouEDC Safety · 1Portal · 2 Read the article
- Safety for the DMC and inspections, fast metrics and a wide patients grid In YouEDC Safety the case summary shows what the current step still needs and moves the case on in one press; the queue has a search and “Take it myself”, and questions from an authority or an ethics committee are kept on the case with the date of the answer. Liver alerts from the Capture lab results reach intake at once, the DMC package takes one button, an inspection has its own room with access until a set day, and the deadline calendar gathers every Safety deadline. The metrics of YouEDC Studio open in seconds, and the patients grid takes the full width of the screen. YouEDC Capture · 1YouEDC Studio · 1YouEDC Safety · 6 Read the article
- Study metrics, Safety by the standards and consent on paper YouEDC Studio has study metrics, and every number on the home page, in the indicators and in the study overview opens the list behind it. YouEDC Safety is a section of its own: E2B nullification and amendment, the E2B check before sending, ACK files, the signal log by GVP IX and priorities with step targets in the worklist. Informed consent is on paper by default, with the scan of the signed form, a study's build is validated in its QA environment, and the Portal Owner sees any study, read only. YouEDC Capture · 3YouEDC Studio · 1YouEDC Safety · 6Portal · 4 Read the article
- Audit trail review, protocol amendments and the help desk The audit trail turns into signals to review under ICH E6(R3), a protocol amendment goes into a running study, and the Help button leads up a ladder of help to a living person. Central statistical monitoring compares the sites, the study status report goes out on a schedule, a confirmed value no longer gets the same query again, and data moves in from CDISC ODM and from the patient's health record in HL7 FHIR R4. The recruitment page with pre-screening opens after the ethics approval, ePRO invitations go out by SMS, a representative can answer for the patient, a talk with the doctor comes before a remote consent, and an authenticator app guards the sign-in. The data management plan is built from the portal, the library has 165 forms, and a new study starts as its QA environment alone. YouEDC Capture · 16Portal · 8 Read the article
- QA as the base of a study, a training environment and YouEDC Studio A new study is built and checked in its QA environment and goes into production with one button; it has a training environment and can start as a copy of another. YouEDC Studio shows the project's data, protocol deviations get a plan, links to eCRF fields and an approved log. Sign-in with the company account over SAML 2.0, a reset of the patient's ePRO PIN and two roles with clear names. YouEDC Capture · 10YouEDC Studio · 3YouEDC Safety · 1YouEDC Trials · 3Portal · 7 Read the article
- Consent from home, a tablet at the site, a safer sign-in A patient signs the consent at home and fills in questionnaires on the site's tablet or on the phone, even without the internet. Data from discharge summaries goes into forms only after the investigator checks it, images get a double central reading, forms can be locked, and the database lock has a forecast. Sign-in can ask for a code from an e-mail, use the company account and work only from the project's network; patients' contacts are stored encrypted in the database. YouEDC Capture · 12YouEDC Studio · 1YouEDC Safety · 1YouEDC Sites · 2Portal · 7 Read the article
- Formulas in the eCRF, DSUR, Kaplan–Meier and RWE tools The eCRF gets free formulas and if-then checks with a live tester. Safety builds the DSUR from the study's data, suggests coding and searches the literature with one press. Biostat draws Kaplan–Meier curves, rates per 100 patient-years and lab shift tables, checked against references, and keeps the analysis plan with its estimands and the cost estimate by tariffs. For real-world data: reasons for missing data, the visit document for the medical record, My data for the patient, pack scan and site performance. The form library gets the organisation's library and disease packs, Studio makes the FDA package, and an eCRF version has its validation kit and the study archive. YouEDC Capture · 8YouEDC Studio · 3YouEDC Safety · 4YouEDC Sites · 1YouEDC Trials · 1YouEDC Biostat · 3Portal · 1 Read the article
- YouEDC Supply, Safety tools and lab results from a photo The portal gets its seventh section, YouEDC Supply: the kit depot, lots, shipments by expiry, quarantine on a temperature excursion and handing out a kit at the visit. Safety gains literature monitoring, causality against the RSI, pregnancy follow-up, SUSAR distribution to sites, signals and E2B import. A doctor enters lab results from a photo of the paper sheet, lab tables show the previous result, Biostat gets the Hy's law plot, patients report events themselves in ePRO, and the test environment is now the QA environment. Every beta tester suggestion has a decision, and the small fixes they asked for are in. The demo catalogue gains eight new studies by kind: RWE, registries, clinical trials, cosmetics and dietary supplements. YouEDC Capture · 6YouEDC Safety · 3YouEDC Trials · 1YouEDC Supply · 1Portal · 12 Read the article
- UAT of an eCRF amendment with signatures, the quick start guide, an unblinded E2B for the authority An eCRF amendment is tested in the test environment by UAT scripts built from its design: a robot runs the checks, the executor signs, another person approves. Newcomers get the quick start guide on four A4 pages with the YouEDC mouse. In a blinded study the authority gets an unblinded E2B(R3). Form tables fill from a paste from Excel, the set-up from the protocol shows its progress, an administrator can delete a study for good, and the demos gain a retrospective RWE study. YouEDC Capture · 3YouEDC Safety · 1Portal · 5 Read the article
- A study from its protocol, lab results from the laboratory's PDF, site statistics in YouEDC Trials Upload the protocol and YouEDC Capture sets the study up by itself, with a log of what to check. Lab results go into the form from the laboratory's PDF, the investigator checks every value. YouEDC Trials shows which site lags behind the study and which patients cause it. Before an eCRF amendment is released you see what it does to the data already collected. The demos gain a study in dogs and a haemophilia registry, and “My suggestions” became a tracker with answers. YouEDC Capture · 3YouEDC Trials · 1Portal · 3 Read the article
- YouEDC Biostat, the sixth section of the portal; “Save and send for review”; website texts for the six sections YouEDC Biostat now has its own tab next to YouEDC Trials, its own colour and its own first page with every study whose report you may read. In both demo studies every chart and the PDF are ready right after creation. The home page, the header and the letters describe the portal as it is now: six sections and everyone who works with them. The main button of a form reads “Save and send for review” and then opens the next form. YouEDC Capture · 7Portal · 1 Read the article
- YouEDC Biostat, tables in a form, dragged fields and signatures confirmed by the study creator The new YouEDC Biostat section counts descriptive statistics from the live data by itself and makes a PDF report. The new Table field holds a lab panel with ranges or the doses of a visit. Fields in the eCRF builder are dragged with a mouse or a finger. The signer's identity is now confirmed by the study creator. YouEDC Capture · 4 Read the article
- ePRO e-mail reminders, the adherence board and a monitoring plan by site risk The patient switches on e-mail reminders about a new questionnaire, and the site sees on one page who answers on time and whom to call. In YouEDC Trials the visit frequency of a site follows its risk level from YouEDC Capture, and the visit report draft is not lost without a connection. YouEDC Capture · 3YouEDC Trials · 2 Read the article
- YouEDC Trials for monitors, ePRO with a QR code, a CDASH form library and second-level coding review The new YouEDC Trials section, a simple CTMS: monitoring visits with the report, site activation, the enrolment plan and fact, action items and protocol deviations. The patient signs in to ePRO with a QR code and a PIN and answers one question per screen; one library of 47 standard forms with CDASH codes; files, images and DICOM attached to a visit; medical coding has a second-level review, queries to the site and moves to a new MedDRA version; a patient is found by ID right from the study's top bar; every number of the data quality report opens the patients behind it; a short weekly “What’s new” letter; the website has a page about ePRO. YouEDC Capture · 8YouEDC Trials · 1Portal · 1 Read the article
- Suggestions arrive by e-mail, the study shows who created it Every new suggestion from the light bulb button comes at once as a letter to the people the admin put on the list; the study overview shows who created the study and when; the site header fits every screen. Portal · 2 Read the article
- Registries: dictionaries, consent, sites, import and API, exports for the statistician and 50 000 patients YouEDC Capture is ready for registries and observational studies. The builder has shared answer lists, the Ministry of Health МКБ-10, a form library and AND / OR conditions across forms. Patients have outcomes of participation, moves between sites, consent with withdrawal and a duplicate search. Sites come from the organisation's directory, and the PI invites the site team. Data arrives from an Excel workbook or through the API from hospital and lab systems, and leaves as cuts with SHA-256, de-identified and for SPSS, Stata, SAS and R. Pages and the audit trail are checked on 50 000 patients. The builder suggests CDISC variable names, and every page has a button to suggest an improvement. YouEDC Capture · 15YouEDC Sites · 1Portal · 5 Read the article
- Visits for registries, a second demo study and a new home page YouEDC Capture gains events, recurring visits, logs and the patient's visit calendar: the first step towards registries and observational studies. A demo project can follow one of two phase III studies, both with everything new from the last release. The home page has a new top, and the “What’s new” card no longer stays once read. YouEDC Capture · 4Portal · 2 Read the article
- Site risk, closing in stages, SDV and approval, 17 field types and “What’s new” YouEDC Capture gains site risk (RBM), closing a study in signed stages, SDV of critical fields and data approval by the data manager, 17 field types, ePRO diary corrections and unblinded-only forms. YouEDC Sites has its own tab. The home page is editable in administration, and every release is now an article in “What’s new”. YouEDC Capture · 6YouEDC Sites · 1Portal · 4 Read the article
- Signatures, randomisation, the casebook and YouEDC Sites as the fourth section The largest issue of stage A. YouEDC Capture now has what a real study needs: the investigator’s e-signature, randomisation, signed eCRF versions, a PDF/A casebook and coding when a form is saved. DM documents write themselves from the builder, YouEDC Sites became the fourth section, and the portal got a demo project, the study passport and the portfolio. YouEDC Capture · 7YouEDC Safety · 1YouEDC Sites · 1Portal · 4 Read the article
- YouEDC Capture, YouEDC Safety and the TMF The EDC moved from YouEDC 0.2 into the portal: the eCRF builder, subjects, data entry, queries, SDV and ePRO. YouEDC Safety for serious AEs and a trial master file prototype arrived. YouEDC Capture · 5YouEDC Safety · 1YouEDC Sites · 1Portal · 2 Read the article
- You can see which version runs A small update: the version in the footer and in the server check, full section names. Portal · 2 Read the article
- The move to youedc.com and the MainEDC export The portal became the main site youedc.com, YouEDC 0.2 moved to old.youedc.com. The home page got indicators, and YouEDC Studio reads a MainEDC™ export as is. YouEDC Studio · 1Portal · 3 Read the article
- The first portal: the foundation and YouEDC Studio The first install of the new portal on PostgreSQL next to YouEDC 0.2: accounts, projects, team, audit trail and the data manager’s full toolset in YouEDC Studio. YouEDC Capture · 2YouEDC Studio · 7Portal · 3 Read the article
What comes next is on the <a href="/roadmap">roadmap</a>.