Back to the portal Four A4 pages: print them or save as PDF.
EN
Русский English Français
Download PDF
YouEDCQuick start guide · 4 pages · build stage-a.20

We strongly recommend reading this before you use the system for the first time

Quick start with YouEDC

The essentials on four pages: how the portal is organised, what each section does and how to get a study going in a day. Ten minutes now save hours later.

The YouEDC mouse doctor

Start in five steps

  1. AccountHome page → “Create account”: name, work e-mail, a password of 10 characters or more. Quick start
  2. A study or a DM projectYour own study is created in YouEDC Capture (wizard: name, code, type, first site), from the protocol PDF or as a copy of an existing one. A study in another EDC is a DM project in YouEDC Studio. Creating a study
  3. Sites and team“Sites and team”: sites with their principal investigators, invitations by e-mail, a role for each person and access to their own sites. Sites and team
  4. eCRF and testingA new study opens in its QA environment: forms, data entry checks and the visit schedule are built there and tried on test patients. Mistakes are fine there, and the team practises in the training environment. eCRF builder QA environment
  5. LaunchThe checked eCRF goes into production with “Release in production”; the launch checklist shows what is missing. Then the sites enter data, and you work with queries and SDV. Launch checklist
Want to look around first? A demo project is made in one click: invented but realistic data in every section. Feel free to break it. Demo project
Can’t find a button? “Help” in the top right corner of any screen opens the article about that very screen. The RU / EN language switch is next to it.
YouEDC2 · Map of the portal

Seven sections on one foundation

One account for the whole study team. Each section has its own colour so they cannot be mixed up. Data moves between the sections by itself: nothing has to be carried over by hand.

Common foundation account · projects · team and roles sites · audit trail · administration YouEDC Captureyour own studies: eCRF, entry,queries, SDV, ePRO YouEDC Studiostudies in other EDCs:reconciliation, CDISC, lock YouEDC SafetySAE cases, Day 0,7- and 15-day clocks YouEDC Sitesmaster file: TMF,versions, quality control YouEDC TrialsCTMS: sites, enrolment,monitoring visits YouEDC Biostatstatistics from live data,Table 1, PDF report YouEDC Supplydrug supply, kitsdispensed by visit SAEs arrive by themselves statistics launch and lock site figures exports from MainEDC,Rave, InForm, Vault

How a screen is organised

1 2 3 4 5
  1. Section switches at the top of the left menu. A section the Portal Owner switched off is not shown.
  2. The menu of the section, and inside a study or project the menu of that project.
  3. Search across the portal finds functions by name too, and inside a study a patient by ID; the language switch.
  4. “Help” opens the article about the current screen. Seven sections
  5. The desk collects what needs a decision: invitations, sites without an investigator, overdue items. Click an item to land where it is fixed.
The YouEDC mouse doctor
YouEDC3 · Sections: data capture and data management

YouEDC Capture for your own studies

  • Build: eCRF builder, answer lists, AND / OR conditions, data entry checks and checks across forms, eCRF versions, the form library and eCRF from Excel. Builder Checks
  • From the protocol or another EDC: upload the protocol PDF and the portal builds the study, the visit schedule and an eCRF draft; a study from another EDC moves in as a CDISC ODM file. Study from its protocol Migration from ODM
  • Site work: patients and the visit matrix, data entry, files, pasting tables from Excel, patient questionnaires (ePRO) by link, the investigator’s electronic signature. Data entry ePRO
  • Quality: queries, SDV and the data manager’s approval, site risk, the data quality report. Queries Monitoring and SDV
  • Output: Excel, CSV and CDISC ODM exports, the export builder, data cuts, closing stages and the database lock. Export Closing

YouEDC Studio for data from other systems

  • A DM project for a study in MainEDC, Rave, InForm, Vault or REDCap: team, tasks, checklists, status. DM projects
  • Tools on an export: data profiler, comparing two exports, query report, data review with marks, overdue visits, SAE and vendor reconciliation. Data profiler What changed
  • Standards and closing: medical coding, lab normal ranges, CDISC SDTM / ADaM / Define-XML, lock readiness. Coding Lock readiness

YouEDC Safety for serious adverse event cases

  • Serious AEs from YouEDC Capture forms arrive in the inbox by themselves; SAE listings from other EDCs are uploaded as a file.
  • Day 0, SUSAR rules, the 7- and 15-day clocks, narrative, discussion and signature of the case, CIOMS I and E2B(R3). Submission to regulators is manual for now. YouEDC Safety
The YouEDC mouse doctor
YouEDC4 · Sections: documents, operations, supply, statistics · rules

YouEDC Sites master file

Study and site documents by TMF Reference Model zones, versions, quality control, expiry dates. Each site has its own page: what is missing and what was requested. The launch and the lock reach the master file by themselves. Master file

YouEDC Trials running the study

Site statuses and activation, planned and actual enrolment, monitoring visits with a report signed twice, actions, a deviation plan and log. Site figures come from YouEDC Capture. YouEDC Trials

YouEDC Supply drug supply

Batches, shipments and receipt by kit number, quarantine after a temperature excursion, resupply. A “Dispense a kit” button in the visit form; the doctor sees the site's stock, blinded staff see kit numbers only. YouEDC Supply

YouEDC Biostat statistics

Enrolment, Table 1, key variables by visit, AEs and safety are computed from live data by themselves, by group only for those allowed to see the groups. A PDF report in one click. YouEDC Biostat

Five rules worth knowing

  1. The audit trail is never changed or deleted. Every change to the data is recorded: who, when, what it was and what it became, with the reason. Audit trail
  2. Rights by role and site. People see only their own studies and their own sites; blinded groups are seen only by those entitled to. Access management
  3. QA environment first. The eCRF is built and checked there and reaches production as a signed, numbered release; data entry follows the current version. eCRF versions
  4. An electronic signature equals a handwritten one. Sign only what you have checked yourself. Signature
  5. No patient personal data. Only the patient’s code, no names or contacts. Security
Where to get help. “Help” on every screen, the full list of articles under “Help”, what is new in each build on the “What’s new” page. Missing something? “Suggest to the developer”: the answer comes with a release. Suggest
The YouEDC mouse doctor

This guide is refreshed every fifth build; this version is for build stage-a.20. The latest is always under “Help” → “Quick start guide”.