YouEDC

The portal for clinical data managers: YouEDC Capture for your own studies, YouEDC Studio for data from other systems, MainEDC™ first of all, YouEDC Safety for SAE cases and YouEDC Sites, the trial and site master file.

Quick start Open the portal

Getting started

Quick start: Sign 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 Biostat: What lives where and how to switch.
Your account: Profile, language, password, signing out everywhere.
Search: studies, people, sites and functions: Find a page or a tool of any section by its name or an abbreviation, only what you may open.
Demo project: A study with invented but realistic data in every section, made in one click.
What’s new: release notes: An article about every release, the card on the desk, and why no release ships without its help.
Help desk: Ask 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 developer: The button on every page: what to write, screenshots, who reads it, the Portal Owner's list.

YouEDC Capture

Creating a study: Study or DM project; name, code, type, the first site.
Study overview and settings: Set-up steps, launch, lock, blinding.
Closing a study: stages and the lock: Enrolment closed, soft lock, database lock: what each allows, the signed move, going back.
Study profile and portfolio: An optional description of the study from lists, the passport on the overview and the portfolio statistics.
Sites and team: Sites, investigators, roles, site access, invitations.
Site directory and organisation: The sites of your organisation entered once for every study, duplicates, loading from Excel, people.
Site performance profile: What the portal measured of a site in your studies, the sites side by side, the site's consent.
Audit trail: What is recorded, how integrity is checked, export.
DM documents: the DVP and the DMP: How the portal writes the data validation plan and the data management plan, versions, signatures, TMF.
Investigator guide: The study’s completion guidelines from the eCRF: draft, versions, the site’s copy.
API for hospital, laboratory and sponsor systems: A key per system, what it may write and read, the calls with examples, the audit.
Actions on event: When a form is saved and a condition holds: send a questionnaire to the patient or open a query to the site.
Outcome adjudication: The endpoint committee classifies the study's events blinded to the treatment: two reviewers, an adjudicator when they differ, the settings and the results.
DM assistant on the local model: Ask 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 review: Signals 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.
A study set up from its protocol: Upload the protocol: the study, its eCRF draft, profile and QA environment are set up, and the log says what to check.
Events, the patient timeline and the visit calendar: Recurring 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 dictionaries: One list for many fields, dependent lists, МКБ-10 and other dictionaries in a field.
Informed consent: Consent versions and their scope, the patient's consent, re-consent, a basis without consent, the two kinds of withdrawal.
Central statistical monitoring: The data of each site against the other sites: the methods, the threshold for many tests, what each finding means and its limits.
Data cuts and the de-identified export: Freeze the data for an analysis with its fingerprint; a copy for the statistician without codes, free text and real dates.
Data import from Excel and CSV: A file into one form: column mapping, the same checks as typing, a report by row.
Data export: Excel or CSV for analysis, with the dictionary and queries; export history.
Bulk data change requests: The 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.
Double data entry: Paper CRFs typed twice by two people: the blind second entry, the differences and how the data manager settles them against the paper.
Data entry deadline and letters to the sites: How 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.
Scheduled data delivery and delta export: The 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.
eCRF builder: Visits and windows, the visit x form matrix, forms, fields and their properties.
Data entry checks: Ranges, “if - then” rules, show-if, “no data”, critical fields, automatic queries.
AND / OR conditions and checks across forms: Show a field, run a check or expect a visit only when conditions on this form, other forms and the patient's card hold.
Remote electronic consent: The patient reads the consent form at home, answers questions on understanding, signs with a code, and the investigator countersigns.
Notes on fields: Explain a value without a query: who writes notes, where they show, how a note is withdrawn, the export and the casebook.
The patient's phone as an app: without the internet and with notifications: The 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 signature: What is signed, who may sign, how to sign, and why a change withdraws the signature.
Export builder and formats for statistics: The 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.
Patient files: All 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.
Files and images in forms: Photos, PDF scans and DICOM studies at a visit: upload, cleaning of personal data, the viewer, the check by the data manager.
Lock of single forms: Lock the forms of an interim analysis or any form on its own; what a lock stops and what goes on; unlocking with a reason.
Lab results from the laboratory's PDF or a photo: Read 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 Excel: The 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 document: A 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.
Medical review: The 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.
Data migration from CDISC ODM: An ODM 1.3.2 file from another EDC: the design, the mapping, a dry run, the load and the migration report.
Data entry without the internet: Take 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.
Scanning drug packs and devices: The 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.
Recruitment page and pre-screening: A 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 quality report: Completeness of each variable by site, outliers, entry delay and loss to follow-up, with the rules behind each number.
Site risk (risk-based monitoring): Key risk indicators of each site, thresholds, the risk level and the record of reviews.
Randomisation: Methods, the scheme editor and the simulator, signatures, randomising a patient, blinding, emergency unblinding and errors.
Biosamples: Tubes registered by their barcode, shipments to the central laboratory with a manifest, the receipt and the reconciliation with the laboratory's results.
Remote SDV by copies of source documents: The site uploads copies of the source documents without personal data, the monitor verifies the visit from the office, the copies are deleted after SDV.
Study status report on a schedule: What 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.
Study launch checklist: What to check before enrolment starts and how to delete test patients at the launch.
Patients and the visit matrix: Enrolment, patient IDs, visit statuses and windows, the patient card and status.
Entering data into a form: Draft 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.
Queries: Automatic and manual queries, answers, closing and reopening, the query list.
Monitoring, SDV and the data manager's approval: SDV of every form or of critical fields only, the data manager's approval after SDV, the SDV and approval list, the monitor's routine.
Forms in several languages: The languages of the study, translating a form, licensed questionnaires, and how the patient chooses a language in ePRO.
Validation kit and study archive: The validation kit of an eCRF version, the UAT scripts on paper, the archive of the whole study in ZIP volumes.
eCRF versions: Testing and release, the draft, comparing versions, deactivating instead of deleting.
QA environment of a study: Test patients for every eCRF amendment: publish the draft to QA, try it, release the same snapshot.
Document for the medical record: The 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.
Visit reminders to the patient: A 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.
Investigator cards: What a card keeps, document expiry, the card file, clinomir.ru and personal data.
Trial Master File: Zones, documents, quality control, metrics, site pages and requests, expiry reminders, inbox, records from YouEDC Capture, site copies at close-out.

YouEDC Studio

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

Administration and security

Administration: Users, functions on and off, limits, usage, system jobs.
Access management: Allow and deny functions to people and groups, role matrix, approval of new accounts, why someone sees what.
E-mail and notifications: Which letters come and how to switch them off, a letter when a long job is done, the Portal Owner’s mail check.
SMS to patients: The 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 data: Passwords, lockout, sessions, where data is stored.
Network access to a project: Let the team in only from listed addresses, not locking yourself out, refused attempts in the audit.
E-mail confirmation, bots, deleting users: Why the e-mail is confirmed, protection from bots without outside services, delete for good or anonymise.
Moving from YouEDC 0.2: How 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 package: The validation documents of the platform and of a study: how each is made, versions, who signs, the ZIP and the TMF.