Demo project

A study with invented but realistic data in every section, made in one click.

A demo project is a study already filled with invented but realistic data, so you can try every section of YouEDC at once instead of entering patients by hand. One click makes a study of your choice, with months or years of history: a randomised double-blind trial (phase III in type 2 diabetes or in arterial hypertension, or a veterinary study of a drug for osteoarthritis in dogs), real-world data (RWE) studies, of rheumatoid arthritis from medical charts, a post-authorisation safety study of an anticoagulant, a pragmatic randomised trial of asthma inhalers in usual care or a survey of people with migraine on their phones, or a registry: of people with haemophilia A, or of people with rheumatoid arthritis on biologic drugs. You get patients and visits in YouEDC Capture, safety cases at every stage in YouEDC Safety, a DM project of the same study in YouEDC Studio and a Trial Master File.

From the sizes to a ready study: the portal creates the projects, a background job writes the history, a letter says when it is ready.

Making one

1. Open Demo project in the YouEDC Capture menu (or the link on the “New study” page).
2. Choose the study. The clinical trials are type 2 diabetes, arterial hypertension and the post-marketing study in psoriasis; the veterinary study, osteoarthritis in dogs; cosmetics, the anti-ageing serum against its vehicle; dietary supplements, the probiotic for bloating; real-world data, the retrospective study of rheumatoid arthritis, the post-authorisation safety study of an anticoagulant the chronic kidney disease cohort on hospital data the pragmatic trial of asthma inhalers and the migraine patient survey; the registries, the haemophilia A registry and the rheumatoid arthritis biologics registry (see “The studies” below). Each person keeps one demo of each study: if you already have it, its card links to it.
3. Choose the size: small, 40 patients, 12 visits, 150 eCRF fields and 80 YouEDC Safety cases, about 1–2 minutes; or large, 100 patients, 20 visits, 200 fields and 300 cases, about 5–7 minutes. The small one is enough to try everything. In the registry the visits set how long it has been running: three months per visit, so three years for the small one and five for the large; its eCRF is always whole.
4. Leave the box ticked to get the YouEDC Studio project of the same study too.
5. Press Create the demo project. The page shows the progress; you can close it: a letter arrives when the demo is ready, and the job is under “My background jobs”.

The form: which study, and how big.

To keep the site responsive, one demo at a time is filled on the whole server, the others wait their turn, and the generator writes in small portions with pauses. A large demo adds about 70 MB to the database, a small one much less. One person makes one demo at a time, keeps one demo of each study (Portal Owners too) and can make three a day. One person keeps at most three demos at once: delete one you no longer need and make it again when you need it, or ask a Portal Owner for a personal limit (set on the user's card).

When it is ready: links to every section, the ZIP of exports for the YouEDC Studio tools, the numbers and the delete form.

The studies

Three are randomised double-blind trials with invented data: two classic phase III trials in people and a veterinary field study in dogs. A phase IV study of a registered biologic is open and has one arm: no randomisation, no placebo, everyday patients. The others use real-world data (RWE): a retrospective study from medical charts, a prospective post-authorisation safety study, a cohort fed by the hospitals’ systems and a registry. Nobody is randomised and there is no study drug: patients are treated as their doctors decide. A real-world data study carries a green RWE badge next to DEMO in the top bar, in the banner and in your lists of projects. They differ in the design and in how data is reviewed, so each shows different settings of YouEDC Capture. A cosmetics or a dietary supplement study tests a product that is not a medicine. On the demo page they are grouped as clinical trials, real-world data, registries, veterinary studies, cosmetics and dietary supplements, each with its own coloured badge.

The clinical trials and the registry: what differs and what they share.

• Type 2 diabetes. YE-101 against placebo 1:1, minimisation by site, sex and HbA1c. The monitor verifies every field, the investigator signs the whole patient after their last visit. Enrolment is open.
• Arterial hypertension. YE-202 20 mg and 40 mg against placebo 1:1:1, permuted blocks of 6 and 9 stratified by site and systolic pressure (below 160, or 160 and above). Screening with a washout of the previous treatment, visits at weeks 2, 4, 8 and 12 (primary endpoint), then an extension to a year. Office pressure is three readings and the mean of the last two, with 24-hour monitoring and the patient's home pressure diary. The monitor verifies critical fields only, the investigator signs each visit, enrolment is closed. Pressure falls more on 40 mg than on 20 mg, and a little on placebo.
• Osteoarthritis in dogs. A veterinary field study (VICH GL9): YE-303 chewable tablets against placebo 1:1, permuted blocks of 4 stratified by clinic and body weight (20 kg or less, or above). The patients are dogs: breed, sex, neutering, weight and body condition score instead of height and body mass index, a microchip number. The owner signs the consent and answers the weekly diary of the dog's pain and mobility on ePRO, so the audit trail names the owner. The vet scores lameness at walk and at trot, radiographs of the affected joint are attached as DICOM, the blood tests have canine ranges. Screening with a washout of painkillers, day 0, days 14, 28 and 56, day 84 (primary endpoint), then an extension to week 24. Amendment 1 added the circumference of the affected limb. The monitor verifies critical fields only, the vet signs each visit. Lameness and pain fall more on YE-303, a little on placebo; vomiting and loose stools are more frequent on the drug. The scales and the owner's diary are our own: no licensed owner questionnaire (CBPI, LOAD, HCPI) is reproduced. In YouEDC Safety the narratives speak of the dog, but the case workflow, the deadlines and the E2B export stay those of human medicine.
• Retrospective study of rheumatoid arthritis (RWE). Nobody is treated for the study: the data come from the medical charts of adults who started a biologic or a targeted synthetic drug years ago, among the invented products YE-901 to YE-907 (TNF inhibitors under the skin and by infusion, an IL-6 receptor blocker, a T-cell co-stimulation modulator, an anti-CD20 antibody, two JAK inhibitors). Day 1 is the index date, the start of the first such drug, so the study's history reaches years into the past. The time points (months 3, 6, 12, 18, 24, then yearly to month 60) take the assessment nearest to them within a window: the tender and swollen joint counts, CRP, ESR, the patient's global assessment and DAS28, calculated by its published formula. When the chart has nothing in the window, or ends before it, the time point is marked not done with the reason. A log keeps the lines of therapy: the drug, dose, methotrexate alongside, the EULAR response, when and why it stopped. Adverse events and serious ones are copied from the chart after they ended. People who are still seen sign a consent; for the others the ethics committee waived it, so the consent page shows the waiver as the basis. The last status (seen, moved away, lost, died) closes each record. The data manager froze an interim data cut. The monitor verifies critical fields only, the investigator signs each visit. In YouEDC Safety the suspect drug is the one of the line the event began on.
• Post-authorisation safety study of an anticoagulant (RWE). A study the authority asked for when it registered the invented YE-610: how often major bleeding, stroke and embolism happen in atrial fibrillation in everyday practice. Nobody is randomised: the physician chose YE-610 or a usual anticoagulant (YE-611, a vitamin K antagonist whose dose follows the INR, or YE-612) before and apart from the study. Elderly patients join over 15 months and each is followed for two years: contacts at months 3, 6, 12, 18 and 24 with wide windows, at the centre, by phone or from the records; vital signs and the kidney function at the centre visits, the stroke and bleeding risk scores at enrolment and each year. A log keeps the anticoagulant: a pause for a procedure, a switch when the INR will not stay in range or the kidneys decline, each record ended with what happened and why. Bleeding, stroke and embolism are adverse events of special interest with their own form: the criteria of a major bleeding, the haemoglobin, transfusions, the INR on admission, what was done with the anticoagulant. The serious ones reach YouEDC Safety with the anticoagulant of that day as the suspect drug. Patients complete their two years, die, withdraw, move to another centre or are lost after calls and a letter; a contact that did not happen is marked not done with the reason. A data cut freezes the data for each yearly safety report. The monitor verifies critical fields only, the investigator signs each visit. The risk scores are the published free ones; no licensed questionnaire or dictionary is reproduced.
• Chronic kidney disease cohort on hospital data (RWE). Adults with chronic kidney disease, stages G3a to G5 and not on dialysis, followed for years as their nephrologists treat them. The site enters little by hand: the enrolment with the patient’s pseudonyms in the laboratory and hospital systems, a yearly review, the start of dialysis or a transplant. The rest comes from the hospitals’ systems: the laboratories of half the centres send each result through the write API with their own key, the others export a file a month that the data manager loads; the hospital information systems send the hospital episodes and the prescriptions through the API. The audit trail shows which key or file each value came from. Kidney function (eGFR by CKD-EPI 2021) falls at each patient’s own pace, faster with diabetes and much albumin in the urine, slower on an SGLT2 inhibitor; potassium rises with it and stops a drug now and then; anaemia brings an erythropoiesis-stimulating agent; some reach dialysis or a transplant. Patients die, withdraw or are lost after calls and a letter; a data cut freezes the data each year. The people, centres, systems and drugs YE-701 to YE-708 are invented; no licensed dictionary is reproduced.
• Pragmatic trial of asthma inhalers (RWE). Two registered, invented inhalers compared as people really use them: YE-710, one inhalation once a day, and YE-711, two inhalations twice a day. Adults with asthma are randomised 1:1 in YouEDC Capture in permuted blocks of 4, stratified by centre and by courses of steroid tablets in the last year; nobody is blinded. Then their own doctors treat them for a year and may change the inhaler (the reason goes to the form). There are few contacts, as in usual care: two clinic visits and three telephone calls, with adherence taken from the pharmacies' refill records, the inhaler technique checked at the clinic and the asthma control check answered on the phone. Each week for a year the patient fills in a short diary on the phone, a recurring event of 52 occurrences, filled less often as the months go by; an attack reported in the diary raises a warning, and the site records it in the exacerbation log with the level of care and the steroid course. The data show what a pragmatic trial is for: the inhalers work alike in the lungs, but the once-a-day one is taken more regularly, so the asthma is a little better controlled. The control check, the diary and the questionnaire are our own: no licensed instrument (ACT, ACQ, AQLQ) is reproduced.
• Migraine patient survey (RWE). A study with patient-reported outcomes (ePRO) only: nobody is treated or seen for it. People with migraine hear of the survey from a headache clinic, a neurologist, a pharmacy leaflet, a patients' organisation or its website. The study team checks by phone that they can take part, which is the only form the site fills in, and the person signs the electronic consent. From then on everything is answered on the phone: about the person and what brings on the attacks at joining, a short headache check-in every month for 6 months (a recurring event: headache and migraine days, medicines for the attack, days lost at work and at home), and a fuller survey at 3 and 6 months on the preventive medicines, life with migraine, work and costs. Some people start or change a preventive among the invented medicines YE-721 to YE-732, and their migraine days fall when it works. An unwanted effect mentioned in a check-in brings a call from the study team, who report it as an adverse event; the serious ones reach YouEDC Safety with the medicine the person was taking. Fewer people answer as the months go by: some stop answering and are lost to follow-up after two reminders, a few withdraw the consent. The questionnaires are our own: no licensed instrument (MIDAS, HIT-6, MSQ, EQ-5D) is reproduced.
• Anti-ageing serum against its vehicle (cosmetics). An efficacy and tolerance study of the invented face serum YE-C10 against the same serum without its active ingredients, double blind, in healthy women 35 to 65 with crow’s feet. Before day 0 each uses only a neutral cleanser for two weeks; then the serum morning and evening for 12 weeks (the primary endpoint: the change of the wrinkle grade) and an extension to week 24. A dermatologist grades the wrinkles, erythema, dryness and scaling; a technician measures the skin in a room at constant temperature and humidity: hydration, water loss through the skin, elasticity, roughness from a 3D image; standardised photographs of the skin are attached to the form. The participant keeps a weekly diary on her phone: how the skin feels, stinging, how many times she applied the serum. The jars are counted and weighed. The active serum moisturises faster and smooths more than the vehicle, and stings some skins in the first weeks. Nobody dies in this study: a severe allergic reaction to the serum or a hospital stay for another reason reaches YouEDC Safety with the serum as the suspect product. The grades and questionnaires are invented; no published photo scale or licensed questionnaire is reproduced.
• Probiotic supplement for bloating (dietary supplements). A double-blind study of the invented probiotic YE-S20, one capsule a day with the invented strain YE-20, against placebo capsules in adults 18 to 60 who feel bloated on two days a week or more. A two-week run-in fills the diary before day 0; 8 weeks on capsules (the primary endpoint: the change of the weekly bloating score), continued use in the long version, and a follow-up two weeks after the last capsule. The participant answers a weekly diary on the phone: bloating days and how bad it was, pain, stool, wind, relief, how much the tummy got in the way. The centre measures vital signs and takes safety blood tests; a central laboratory counts the strain in the stool and measures faecal calprotectin, and its transfer is reconciled in YouEDC Studio. Both arms improve, the probiotic more; the strain is found on YE-S20 only and mostly leaves after the capsules stop. Nobody dies; the rare serious event the label warns about is the strain in the blood. The diary and its scales are invented; no licensed questionnaire or published stool chart is reproduced.
• Post-marketing study in plaque psoriasis (phase IV). An open-label, single-arm study of the registered, invented biologic YE-501 in everyday patients with moderate to severe plaque psoriasis: older people, comorbidities, earlier biologics. No randomisation, no placebo, no blinding: every patient included gets YE-501 from week 0, for 52 weeks. Injections at weeks 0, 4, 16, 28 and 40 are recorded with the syringe, its lot and expiry date, and the syringes are accounted for. The PASI is scored by body region and the portal adds it up; the body surface area, a physician global score and the patient’s own questionnaire on the phone follow it. About three patients in four reach PASI 75 at week 16; some lose part of the response later in the year. Infections and injection site reactions are adverse events of special interest; the serious ones reach YouEDC Safety with YE-501 as the suspect drug, given under the skin. PASI is a published free score; no licensed questionnaire is reproduced.
• Haemophilia A registry. Children and adults followed for years, each treated as their haematologist decides: prophylaxis or on demand with the invented products YE-800 to YE-809 (a plasma-derived factor, a standard and an extended half-life factor, a non-factor therapy under the skin, a bypassing agent). Most people join in the registry's first months. After the enrolment there is a follow-up visit every 6 months for as long as the person takes part, a recurring event: the bleeds and missed days since the last visit, the joints, vital signs, laboratory (the factor VIII level and the inhibitor), and the person's own questionnaire on the phone. Between the visits the site adds to the logs: bleeds from the person's diary (some only at the next visit, a few never, so the counts and the log can disagree), treatment regimens (a change ends one record and opens the next, with the reason), operations and admissions, adverse events. The bleeding rate follows the regimen and how regularly the doses are taken; a few small children develop an inhibitor and start immune tolerance induction. People leave as they do in a registry: some are lost to follow-up after unanswered calls and letters, some withdraw their consent (a few also the use of their data, so they leave the exports), some move to another centre, some die. Consent version 2.0, approved about a year ago, asks everybody to sign again; most have signed it at their next visit, the rest are waiting. The data manager froze a data cut for each yearly registry report. The monitor verifies critical fields only, the investigator signs each visit and each follow-up. In YouEDC Safety the suspect drug is the product the person was on when the event began. The questionnaire and the joint assessment are our own: no licensed instrument (Haem-A-QoL, HJHS, EQ-5D) is reproduced.
• Rheumatoid arthritis biologics registry. Eight rheumatology centres follow adults with rheumatoid arthritis on biologic and targeted drugs for years, each treated as their rheumatologist decides with the invented drugs YE-901 to YE-907. About half come with a drug started before, the others start their first one at enrolment. At enrolment: the diagnosis, the antibodies, the screening for tuberculosis and the vaccinations, the disease activity, the laboratory and the person's own questionnaire on the phone. Then a follow-up visit every 6 months, a recurring event: glucocorticoids, infections, admissions and days off work since the last visit, DAS28-CRP with the EULAR response against enrolment, the questionnaire and the laboratory. The therapy log keeps each drug from the first one: a drug that does not work is switched within months, one that works may stop working later, and 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 depends on the class list, so after the class only its drugs are offered. Adverse events mark the registry's events of special interest; a serious infection also asks for its site, the pathogen and intravenous antimicrobials. People leave, move and sign the new consent version as in the haemophilia registry; a data cut for each yearly report. In YouEDC Safety the suspect drug is the one the person was on when the event began. DAS28-CRP and the EULAR response are published formulas; the function questions are our own, no licensed questionnaire (HAQ-DI, RAPID3, RAID) is reproduced.

The dog study: the vet's orthopaedic examination with the lameness score, the primary endpoint.

The registry: one person's follow-up visits every 6 months on the timeline, each signed by the investigator.

What is inside

The history follows the study's own time: design, launch, first patient, today. What is still open today is what you work on.

YouEDC Capture

• eCRF with exactly the number of fields asked: demographics, eligibility, medical history, vital signs, haematology, chemistry, HbA1c or office and 24-hour pressure, lipids, randomisation, study drug, a patient questionnaire, ECG, physical exam, urinalysis and more, plus the adverse event, concomitant therapy and end-of-study logs. Above the standard forms a long symptom questionnaire grows. The questionnaires are our own: no licensed instrument (EQ-5D, SF-36) is reproduced.
• 2 to 8 sites that open one after another, each with its own habits: one enters data within two days and its monitor verifies nearly everything, another is late and answers queries slowly.
• Patients with a believable story: screen failures, withdrawals, completers, a few deaths. Values drift realistically (HbA1c or pressure falls on treatment, weight changes), labs have their normal spread and occasional abnormal results.
• The lipid panel is a table in the form: the study keeps its laboratories' normal ranges (one site reports in mg/dL and its range is converted into mmol/L), so results show the site's range and the L or H flag, and LDL is calculated by Friedewald.
• Work on the data: drafts, typos corrected with a reason, values out of range and the queries they raise, monitor and data manager queries, answers and closures, SDV, visits missed or out of window.
• The new functions at work: a drug accountability form seen by the unblinded only (a pharmacist keeps it, an unblinded monitor verifies it), the data manager's approval after SDV, investigator signatures, patients' requests to correct ePRO answers, approved and rejected, and risk reviews of the three riskiest sites.

The demo study: a DEMO badge in the top bar and a banner on every page, so it is never taken for a real one.

YouEDC Safety

• Serious adverse events entered in the study reach the safety intake by themselves; a few arrive on paper. Planned hospitalisations are rejected as not serious, follow-ups are attached to their case.
• Cases are at every stage: new, in progress, medical review, QC and closed. Possible SUSARs are unblinded, reported to the authority and the ethics committee within 7 or 15 days; a few reports are late, so you see what an overdue case looks like.
• MedDRA codes are left empty: the dictionary is licensed and each organisation uploads its own.

YouEDC Safety in the demo: open cases, deadlines that are due or overdue, SUSAR clocks, reports waiting in the intake.

YouEDC Studio and the TMF

• The DM project of the same study: start-up tasks done before the first patient, regular conduct tasks, the lock checklist opened two months ago.
• Lock readiness with counters per site taken from the study itself: open and answered queries, pages awaiting SDV, expected pages not entered.
• Lab normal ranges of the central laboratory, by sex where labs split them, and one site with its own blood counts. One test is left without a range on purpose.
• A ZIP of exports of the study in the shapes other EDC systems give, one folder per tool: queries/ for the query report, visits/ for overdue visits, xchecks/ for cross-form checks, recon/ for SAE reconciliation, review/ (two weekly snapshots) for data review, vendorrec/ for vendor reconciliation, labs/ for the lab ranges check. A few mismatches are planted so the tools find something.
• The Trial Master File of the study: documents filed, waiting for QC, returned, an expired GCP certificate, items in the inbox.

The audit trail of a demo

The history is written in time order and its audit records carry the invented dates, so the audit trail reads like months of work. The first records, the creation of the project, keep the real date and time. Only projects marked as demo can get invented dates: for any other project the portal refuses it. The audit chain stays valid and can be checked as usual. Deleting a demo deletes its audit trail with it (see below).

Deleting a demo

Press Delete the demo on the demo page (the link “About this demo and deleting it” in the banner) or Delete in the list “My demo projects”, and confirm. The deletion runs in the background in small portions; the page shows the demo is being deleted.

• Everything goes: the study and its YouEDC Studio project with all their data, signatures, files, the whole audit trail of these projects and the invented people no other demo uses. The database reuses the freed space for new data at once.
• The portal's own audit trail keeps one line: who deleted which demo. That trail is one chain for the whole portal, and a gap in it would break its integrity check.
• Only demo projects can be deleted this way. A real study never loses its audit trail or signatures (21 CFR Part 11, GCP): the database refuses it, even to a Portal Owner.

What keeps it apart from real work

• Every person in a demo is invented. The team are inactive accounts at the reserved domain demo.invalid: nobody can sign in as them and no letter can reach them.
• Reminders about safety deadlines are never sent for demo projects.
• Demo projects do not count towards your limit of projects.
• The Portal Owner can switch demo projects off or change their limits in Administration, Functions and limits.

Try anything. Enter a patient, answer a query, close a case, run a YouEDC Studio tool on the ZIP. Nothing reaches real people, and the demo can be deleted at any time.