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Quick startSign up, create a study, invite the team, open YouEDC Studio. Seven sections: YouEDC Capture, YouEDC Studio, YouEDC Safety, YouEDC Sites, YouEDC Trials, YouEDC Supply, YouEDC BiostatWhat lives where and how to switch. Your accountProfile, language, password, signing out everywhere. Search: studies, people, sites and functionsFind a page or a tool of any section by its name or an abbreviation, only what you may open. Demo projectA study with invented but realistic data in every section, made in one click. What’s new: release notesAn article about every release, the card on the desk, and why no release ships without its help. Help deskAsk in your own words, why can't I, questions to the study team and to YouEDC support, urgent security questions, the knowledge base. Suggest to the developerThe button on every page: what to write, screenshots, who reads it, the Portal Owner's list.

Creating a studyStudy or DM project; name, code, type, the first site. Study overview and settingsSet-up steps, launch, lock, blinding. Closing a study: stages and the lockEnrolment closed, soft lock, database lock: what each allows, the signed move, going back. Study profile and portfolioAn optional description of the study from lists, the passport on the overview and the portfolio statistics. Sites and teamSites, investigators, roles, site access, invitations. Site directory and organisationThe sites of your organisation entered once for every study, duplicates, loading from Excel, people. Site performance profileWhat the portal measured of a site in your studies, the sites side by side, the site's consent. Audit trailWhat is recorded, how integrity is checked, export. DM documents: the DVP and the DMPHow the portal writes the data validation plan and the data management plan, versions, signatures, TMF. Investigator guideThe study’s completion guidelines from the eCRF: draft, versions, the site’s copy. API for hospital, laboratory and sponsor systemsA key per system, what it may write and read, the calls with examples, the audit. Study status report on a scheduleWhat goes in the weekly or monthly report for the sponsor, who gets the letter, what each reader sees, the Excel and PDF, and how to show what was sent. Data import from Excel and CSVA file into one form: column mapping, the same checks as typing, a report by row. Data exportExcel or CSV for analysis, with the dictionary and queries; export history. Scheduled data delivery and delta exportThe weekly file for the statistician, the DSMB or the medical monitor on a schedule, on the portal or to SFTP, with its SHA-256; or only what changed since the previous delivery, with the reasons. Study launch checklistWhat to check before enrolment starts and how to delete test patients at the launch. Patients and the visit matrixEnrolment, patient IDs, visit statuses and windows, the patient card and status. Entering data into a formDraft or complete, edit checks, “no data”, the reason for a change, the history of a value. Patient questionnaires (ePRO)The patient's personal link, what the patient sees, how to revoke access. QueriesAutomatic and manual queries, answers, closing and reopening, the query list. Monitoring, SDV and the data manager's approvalSDV of every form or of critical fields only, the data manager's approval after SDV, the SDV and approval list, the monitor's routine. Events, the patient timeline and the visit calendarRecurring visits, events on event and logs; the actual date of a visit; the patient's timeline and calendar; the site's month of visits. Patient casebook (PDF)A certified copy of a patient's data with the queries and the audit trail; the casebooks of a site in one zip for the archive. Answer lists and dictionariesOne list for many fields, dependent lists, МКБ-10 and other dictionaries in a field. Informed consentConsent versions and their scope, the patient's consent, re-consent, a basis without consent, the two kinds of withdrawal. Remote electronic consentThe patient reads the consent form at home, answers questions on understanding, signs with a code, and the investigator countersigns. Notes on fieldsExplain a value without a query: who writes notes, where they show, how a note is withdrawn, the export and the casebook. Data cuts and the de-identified exportFreeze the data for an analysis with its fingerprint; a copy for the statistician without codes, free text and real dates. Actions on eventWhen a form is saved and a condition holds: send a questionnaire to the patient or open a query to the site. eCRF builderVisits and windows, the visit x form matrix, forms, fields and their properties. Data entry checksRanges, “if - then” rules, show-if, “no data”, critical fields, automatic queries. AND / OR conditions and checks across formsShow a field, run a check or expect a visit only when conditions on this form, other forms and the patient's card hold. The patient's phone as an app: without the internet and with notificationsThe home screen without a store, questionnaires answered without the internet and sent later, encrypted, the notifications and the push services. The patient sees their own data (ePRO)What the study shows the patient of their own data, the site's approval for each patient, what the patient sees and what is never shown. Investigator electronic signatureWhat is signed, who may sign, how to sign, and why a change withdraws the signature. Lock of single formsLock the forms of an interim analysis or any form on its own; what a lock stops and what goes on; unlocking with a reason. DM assistant on the local modelAsk the study in words and get a table counted by the portal; let the installation's own language model review a patient for inconsistencies; you decide on every proposal. Audit trail reviewSignals from the audit trail of the study worth a look, critical data first: what each one means, how to mark it reviewed or raise a query, and the lock readiness item. Medical reviewThe medical monitor's listings of adverse events, lab results and therapy on live data: marking lines reviewed, what "changed since the review" means, the medical query to the site. Outcome adjudicationThe endpoint committee classifies the study's events blinded to the treatment: two reviewers, an adjudicator when they differ, the settings and the results. BiosamplesTubes registered by their barcode, shipments to the central laboratory with a manifest, the receipt and the reconciliation with the laboratory's results. Double data entryPaper CRFs typed twice by two people: the blind second entry, the differences and how the data manager settles them against the paper. Recruitment page and pre-screeningA public page of the study with the approved description and a short questionnaire; the consent, the site's leads, a patient from a lead, deletion and the counts. Data entry deadline and letters to the sitesHow many working days the site has to enter a visit, what counts as late, the page of late entries and the letter to each site. Export builder and formats for statisticsThe forms and variables you need, a row per visit or per patient, in SPSS, Stata, SAS, R, Excel or CSV. Data from a health record (HL7 FHIR R4)A patient's FHIR Bundle from the hospital's system: labs, vital signs, conditions and medications into the eCRF, checked and confirmed by the site. Files and images in formsPhotos, PDF scans and DICOM studies at a visit: upload, cleaning of personal data, the viewer, the check by the data manager. Patient filesAll the files the sites uploaded into the eCRF in one place: what is expected, the check for personal data, the reading of images by central readers. Lab results from the laboratory's PDF or a photoRead the lab's PDF or a photo of its sheet into a form, check each value, the site's lab profile. Form library, copying and eCRF from ExcelThe YouEDC standard forms (CDASH codes, Russian and English), a copy of a form or of a whole study, forms and visits from an Excel workbook. Data from a medical documentA discharge summary, a test report or a conclusion as a PDF or a photo: values for the form's fields, each checked by the investigator. Data migration from CDISC ODMAn ODM 1.3.2 file from another EDC: the design, the mapping, a dry run, the load and the migration report. Scanning drug packs and devicesThe DataMatrix of a drug pack or the UDI of a device read from a photo: the product, the INN, the batch and the expiry date in the eCRF without typing. Data quality reportCompleteness of each variable by site, outliers, entry delay and loss to follow-up, with the rules behind each number. Forms in several languagesThe languages of the study, translating a form, licensed questionnaires, and how the patient chooses a language in ePRO. Site risk (risk-based monitoring)Key risk indicators of each site, thresholds, the risk level and the record of reviews. Central statistical monitoringThe data of each site against the other sites: the methods, the threshold for many tests, what each finding means and its limits. RandomisationMethods, the scheme editor and the simulator, signatures, randomising a patient, blinding, emergency unblinding and errors. Remote SDV by copies of source documentsThe site uploads copies of the source documents without personal data, the monitor verifies the visit from the office, the copies are deleted after SDV. Bulk data change requestsThe data manager prepares one change for many records, the sites confirm it as a batch against their source documents; everything is in the audit trail. Visit reminders to the patientA few days before the window of a visit, the patient gets an SMS or an e-mail with the dates only, through the channel already set up for ePRO. Data entry without the internetTake empty copies of the patients' forms on your own device, fill them in without the internet, and they go to the server when it is back. A study set up from its protocolUpload the protocol: the study, its eCRF draft, profile and QA environment are set up, and the log says what to check. Validation kit and study archiveThe validation kit of an eCRF version, the UAT scripts on paper, the archive of the whole study in ZIP volumes. eCRF versionsTesting and release, the draft, comparing versions, deactivating instead of deleting. QA environment of a studyTest patients for every eCRF amendment: publish the draft to QA, try it, release the same snapshot. Document for the medical recordThe registry visit printed as an examination note for the patient's medical record: the doctor fills the visit once and signs the printout by hand. Investigator cardsWhat a card keeps, document expiry, the card file, clinomir.ru and personal data. Trial Master FileZones, documents, quality control, metrics, site pages and requests, expiry reminders, inbox, records from YouEDC Capture, site copies at close-out.

YouEDC StudioDM projects and tools for studies in any EDC. DM projectsA study in another system: team, tasks, checklists, status, archive. Data profilerCheck an EDC export: types, gaps, duplicates, outliers. CDISC: SDTM, ADaM, Define-XMLSources, the mapping specification, the build, checks, licences and limits. Check effectivenessHow a query is judged to have changed the data, and how to read the verdicts. Medical codingDictionaries, how terms are matched, your decisions, licences. What changed: compare two exportsNew, removed and changed records between two exports of a listing. Study metricsWhat each metric counts, where the data comes from and the lists behind the numbers. Project data: deliveries and historyUpload an export once, every tool takes it; YouEDC Studio inside a Capture study. Lab normal rangesLoad ranges per site, keep versions, check a lab export against them. Lock readinessChecklist, counters per site and the readiness status before database lock. MainEDC exportWhat the MainEDC export looks like, how it is read and what is checked. Export to CDISC ODMWhat ODM is, how the export is read, keys, data types, validation. Protocol to study buildVisits, forms and fields drafted from a protocol's schedule of activities. Comparing protocol versionsWhat an amendment changes in the schedule and in the eCRF. eCRF specification from a protocolWhat the specification contains, how versions work and how to read it back. Query reportAgeing, site response time and query hot spots from a query listing. SAE reconciliationHow events are paired, what is compared and how comments carry over. Data review with marksReview rounds in Excel: marks carry over, changed rows come back. Specification checkWhat the check finds in an eCRF specification and how to read the report. Vendor reconciliationHow samples are paired, what is compared, visit codes and extra columns. Overdue visits and missing pagesWhich listings to upload, how the schedule is written, how due dates are counted. Cross-form checksWhich listings to upload, what each check looks for, the visit schedule.

YouEDC SafetySerious adverse event cases: intake, Day 0, SUSAR, 7/15-day deadlines, roles.

YouEDC TrialsSite statuses and activation, enrolment, monitoring visits, reports and letters, action items, protocol deviations. Site payments by visitsThe fee schedule, accruals for completed and verified visits, statements confirmed by the site, the payment, the holdback and the act.

YouEDC SupplyThe study drug from the depot to the patient: setup, shipments and receipt, dispensing on the visit form, the site's shelf, the movement of kits.

Analysis plan and estimandsThe question of the study as an estimand of ICH E9(R1) and a target trial, written before the data, checked against the eCRF and kept as versions. YouEDC Biostat: the study's statistics by itselfTen charts and the tables of efficacy and safety from the live data, by arm when the reader may see the arms, and the PDF of the report. Cost estimate by tariffsThe healthcare resource use the sites record, the tariff table of the study and what the recorded care would cost by it, per patient and per patient-year.

AdministrationUsers, functions on and off, limits, usage, system jobs. Access managementAllow and deny functions to people and groups, role matrix, approval of new accounts, why someone sees what. E-mail and notificationsWhich letters come and how to switch them off, a letter when a long job is done, the Portal Owner’s mail check. SMS to patientsThe SMS gateway of the portal, the patient's consent and number, what the message says, quiet hours and limits, the delivery log, legal notes. Sign-in with the company account (SSO)For CROs and sponsors: signing in through the company's provider, connecting it, closing password sign-in. Security and personal dataPasswords, lockout, sessions, where data is stored. Network access to a projectLet the team in only from listed addresses, not locking yourself out, refused attempts in the audit. E-mail confirmation, bots, deleting usersWhy the e-mail is confirmed, protection from bots without outside services, delete for good or anonymise. Moving from YouEDC 0.2How studies and their data move from YouEDC 0.2, and the three checks. Validation kit (UAT / PQ)How a company tests YouEDC internally: scripts, demo study, sign-off, report. Validation packageThe validation documents of the platform and of a study: how each is made, versions, who signs, the ZIP and the TMF.