stage-a.16: YouEDC Supply, Safety tools and lab results from a photo

YouEDC Capture

The test environment of a study is now called the QA environment: an orange “QA” badge instead of “TEST” in the study list and on its pages, “Publish the draft to QA”, “[QA]” in the subject of letters to its patients. A new QA environment gets a code ending in -QA; the ones already made keep -TEST, so links and exports do not break. Test patients and the test randomisation numbers keep their names QA environment of a study
The Hy’s law plot (eDISH) in YouEDC Biostat. Each patient is a point: their highest ALT and total bilirubin as multiples of the upper limit of normal from the study’s own lab normal ranges (for the site, sex, age and visit date), log axes, lines at 3 × ULN and 2 × ULN. The quadrants potential Hy’s law, Temple’s corollary and bilirubin only, and the list of patients for the safety physician: bilirubin ≥ 2 × ULN within 30 days after ALT ≥ 3 × ULN. The patient’s code on a point and the link to them only for readers who may open patients; the PDF carries no codes. Without the study’s ranges the plot is not drawn: the portal never guesses the ULN. The human demos have liver test ranges and one drug-induced liver injury YouEDC Biostat: the study's statistics by itself
Delta checks in lab tables: the previous visit’s result shows under the result (“before: 90 · Screening”), and the builder’s Change, max column sets the largest change of a row since the previous visit, in the row’s unit (30) or in per cent (50%). A bigger change opens a query on the cell, and a corrected value closes it by itself. The lab panel sets 50 % for creatinine and 100 % for ALT, the demo 50 % for triglycerides Entering data into a form · eCRF builder
ePRO, stage 2. An event diary: under “Something happened?” the patient reports an event, for example an episode of low blood sugar, without waiting for a questionnaire; an alarming answer opens a query for the site. Diary hours on a visit (for example 18 to 23 for an evening diary) limit only the patient. The patient sees how many of the last questionnaires they sent, and a thank-you. Scale mode: the passport of a licensed questionnaire (the instrument, version, owner, licence end with a warning) and locked texts that are unlocked only with a reason in the audit trail. Calculated fields compute a mean and a questionnaire score with a rule for missing items; the patient does not see the score. The library gets free formats: a 0–10 numeric rating scale of symptoms and a 0–4 verbal one, each with a score. The form settings pop-up and the visit form fit a phone screen Patient questionnaires (ePRO)
Lab results from a photo of the paper sheet. The physician photographs the sheet with a phone, puts four corners on the results table (the header with the patient’s name stays outside), and the values go to the form’s rows as from a PDF. The photo is read by Tesseract on the portal’s own server, with no outside service; every number is read twice, and the reader’s doubts show in the line. The check shows each line’s piece of the photo next to it, and the physician ticks every value; the piece that was read is kept with the document as the source. A blurred or small photo is asked to be taken again. The demo has the button “Take a demo photo” Lab results from the laboratory's PDF or a photo
From the beta testers' suggestions: the auto-setup log has the button “Accept all rows to check” (contradictions stay to be decided one by one); the visit calendar shows only visits, no adverse events or logs; on the patient card each event shows its name from the form; the patient list has the filter “Not completed”; the launch plan has the step “Set up informed consent”, and finished steps can be opened again; the settings have a link back and no “Blinded study” switch in a registry; a manager no longer changes their own access or unblinding, another manager does it A study set up from its protocol · Events, the patient timeline and the visit calendar · Study launch checklist · Sites and team · Patients and the visit matrix

YouEDC Safety

YouEDC Safety: literature screening. Saved searches of a product in PubMed (NCBI E-utilities), Europe PMC and Crossref run on a schedule (at least weekly) or by a button; a run log for the inspector: database, exact query, dates, found and new. Articles are merged by PMID, DOI and title and screened once; a case report opens a case with Day 0 and the reference in the narrative and the E2B. Official APIs only; the portal never scrapes Google or Yandex results. The server goes online only when the administrator lists the databases in LITERATURE_SOURCES YouEDC Safety
YouEDC Safety: medical assessment. Reference safety information (RSI) in versions with the date each comes into force; an event shows whether it is in the RSI on its onset date, and expectedness is set with one button; after a new version, the list of cases that differ. WHO-UMC and Naranjo causality worksheets with answers from the case data. GVP VI special situations and a pregnancy followed to its outcome with a reminder. The “Timeline” tab: products, events, visits from Capture, Day 0, requests, reports and deadlines on one axis YouEDC Safety
YouEDC Safety: SUSARs to the investigators, sending per site and confirmation of receipt, late ones highlighted. The “Signals” tab: events by month and the flags rising, one site, unlisted, fatal, with no breakdown by arm. An E2B(R3) file from a partner into intake (patient, reactions, products, narrative) and the ACK sent back YouEDC Safety

YouEDC Trials

Statistics across studies in YouEDC Trials. The Statistics across studies tab next to the monitor's desk: totals (studies, sites, patients enrolled against the target and the plan, sites with a red cell, open queries, SDV, late reports, studies whose enrolment ends after the plan), the studies table with the enrolment bar, the forecast end at the rate of the last 8 weeks, the sites by colour and a 12-week trend, the top 10 sites needing attention across studies (each indicator opens the site's patients) and What changed in 7 days. The project's statistics tiles and the site card gain 12-week sparklines, the Enrolment tab a forecast on its chart. The home screen gets the Studies in YouEDC Trials widget. Everything is read from the daily summaries, nothing is recounted; who sees what follows the project's statistics. A demo study has the summaries of every Monday of 12 weeks YouEDC Trials

YouEDC Supply

YouEDC Supply, the portal's seventh section. The supply manager (a new role) sets the supply up in five steps: kit types by randomisation arm with a blinded name on the label, a depot, batches with their expiry released by a second person, the kit list (numbers shuffled in blocks) and the dispensing schedule: at which visit and in which form how many kits. A shipment is picked by expiry (what expires first goes first, with a “do not dispense within N days” margin), travels with a waybill and is received at the site kit by kit; a temperature excursion sends the kits to quarantine until a decision. A site opens with an initial shipment and then resupplies itself by a trigger level and the visit forecast; at night expired kits are taken out. The movement screen shows the depot, transit, sites, patients, returns and quarantine, with a stock chart for every site. The movement journal can't be changed. The “Dispense a kit” button sits in the visit form: the system picks the number by the patient's arm, the expiry and the site's stock, at random among kits of the same expiry; a damaged or lost kit can be replaced, and a return records the drug left. The doctor sees the site's stock and the patient's kits on their card. The blinded team sees kit numbers and expiry only, and the audit trail records numbers and places, never arms. The t2d, htn and dog demo studies have a supply YouEDC Supply · Seven sections: YouEDC Capture, YouEDC Studio, YouEDC Safety, YouEDC Sites, YouEDC Trials, YouEDC Supply, YouEDC Biostat

Portal

The website, the quick start guide, the help and the welcome letter name seven sections: “YE Supply” in the site header and a YouEDC Supply block on the home page, a stage of its own on the roadmap Seven sections: YouEDC Capture, YouEDC Studio, YouEDC Safety, YouEDC Sites, YouEDC Trials, YouEDC Supply, YouEDC Biostat
Demo: a post-authorisation safety study (PASS) of an anticoagulant in atrial fibrillation, with the green RWE badge. No randomisation: the physician chooses YE-610 or a usual anticoagulant. Contacts at 3, 6, 12, 18 and 24 months at the centre, by phone or from the records; a treatment log with switches and pauses, the INR of the patients on the vitamin K antagonist, the risk scores. Bleeding, stroke and embolism have their own form with the criteria of a major bleeding; the serious ones reach YouEDC Safety with the anticoagulant of that day. Patients complete, die, withdraw, move to another centre or are lost after contact attempts; a data cut for each yearly report Demo project
Demo: a chronic kidney disease cohort on hospital data, with the green RWE badge. The site enters only the enrolment, a yearly review and the start of dialysis or a transplant; the laboratories of half the centres send results through the write API with their own key, the others a monthly file the data manager loads; the hospital systems send the hospital episodes and prescriptions. The audit trail shows which key or file each value came from. eGFR by CKD-EPI 2021 falls at each patient's own pace, some reach dialysis; a data cut each year Demo project
The quick start guide on the help and the desk: two buttons, “Read in the portal” and “Download PDF”. The PDF in Russian and English is ready in advance and matches the pages in the portal. The red “Quick start in 10 minutes” banner above the help is gone, it repeated the guide; the “Quick start” article stays under “Getting started” Quick start
Demo: a cosmetics study of the anti-ageing serum YE-C10 against its vehicle, in its own Cosmetics section. Healthy women 35 to 65, double blind, 12 weeks and an extension to week 24. A dermatologist grades wrinkles and irritation, instruments measure hydration, water loss, elasticity and roughness of the skin, standardised photographs of the skin are attached to the form; the participant keeps a diary on her phone, the jars are weighed. Serious reactions reach YouEDC Safety with the serum as the suspect product Demo project
Demo: a study of the probiotic dietary supplement YE-S20 against placebo for bloating, in its own Dietary supplements section. Adults 18 to 60, double blind, a two-week diary run-in, 8 weeks on capsules and a follow-up two weeks after the last one. A weekly diary on the phone, safety blood tests, a central laboratory counts the strain in the stool and measures calprotectin; capsules, not tablets, in the accountability forms Demo project
Demo: a third clinical trial, an open single-arm post-marketing (phase IV) study of the registered biologic YE-501 in plaque psoriasis, in everyday patients. No randomisation or placebo, injections with the syringe, lot and expiry, accountability of the syringes, PASI by body region added up by the portal, the patient's questionnaire on the phone; serious events reach YouEDC Safety with YE-501 under the skin. Lock readiness marks unblinding as not applicable for an open study Demo project
Demo: a pragmatic randomised trial of two asthma inhalers in usual care, with the green RWE badge. Randomised 1:1 in the EDC in blocks stratified by centre and steroid courses, open label; a year of treatment by the patients' own doctors, who may change the inhaler. Two clinic visits and three calls, adherence from the pharmacies' records, the asthma control check on the phone, a weekly diary for 52 weeks as a recurring event and an exacerbation log: the once-a-day inhaler is taken more regularly and asthma is a little better controlled Demo project
Demo: a migraine patient survey, answered only on the phone (ePRO), with the green RWE badge. The study team checks the criteria by phone and the person signs an electronic consent; then the answers at joining, a monthly headache check-in for 6 months as a recurring event and a fuller survey at 3 and 6 months on medicines, life with migraine, work and costs. An unwanted effect in a check-in becomes a side effect report; people stop answering and are lost after reminders Demo project
Demo: a second registry, biologic and targeted therapy of rheumatoid arthritis at eight centres. A follow-up visit every 6 months with DAS28-CRP and the EULAR response against enrolment, the person's questionnaire on the phone, the laboratory; a therapy log from the first drug to the current one, a switch closes the record with its reason. The drug, its class and the reason for stopping come from the study's answer lists, the drug list depending on the class. The registry's adverse events of special interest: a serious infection asks for its site, the pathogen and intravenous therapy; in YouEDC Safety the suspect drug is the one the person was on that day Demo project
The demo page is split by kind of study: clinical trials, real-world data, registries, veterinary studies (the dog study moved there); an empty section is not shown. Every section and card has its own coloured badge (trial, RWE, registry, vet, cosmetics, supplement) and the full design below it; every demo shows the compact badge of its kind, as wide as its word, in the demo banner and the project header Demo project
A letter to the authors of suggestions. When T.G.’s answers come with a release, each author gets one letter in their language: thanks, how many of their suggestions are done, planned, under discussion and not planned, and what we think about each one answered. The button opens “My suggestions” Suggest to the developer

Improvements and fixes

Answers to suggestions reach the author in the language of their account (they always came in English); the home page wording is clearer after the beta testers' remarks
YouEDC Biostat: Table 1 at full width, chart cards leave no empty space at any screen width