Creating a study

Study or DM project; name, code, type, the first site.

The top of the page shows how a study is made: it appears as its QA environment, where the team builds the eCRF and tries it on test patients; “Release in production” copies the checked eCRF and settings to production, where investigators at the sites enter real patients. Below it, four cards say where to start: Make a demo project, Set up from the protocol, Collect data in YouEDC (Capture) and Work with data from another system (Studio).

“New project” first asks what the project is for. Collect data in YouEDC creates a study: the steps below. Work with data from another system creates a DM project: name, code, the system, phase and dates, no sites.

1. Name and code

   A short Latin code such as REG-DIAB-01. It is suggested from the name and can be edited. The code appears in subject numbers and exports, so avoid changing it after launch.

2. Study type

   Registry, observational, retrospective, patient survey (ePRO) or clinical trial. The type suggests the template in the next step.

3. Template

   Where the eCRF starts: Registry (enrolment, visits at 6 and 12 months, therapy, adverse events, a patient questionnaire), Observational study (three visits over six months with windows), Retrospective study (one visit, “Abstraction from the medical record”), Patient surveys (ePRO) (questionnaires at the start, after 4 and 12 weeks) or Blank study (one visit and one empty form). Each card shows the template's visits. Visits, forms and edit checks are created at once, in your interface language, and everything can be changed in the eCRF builder.

4. First site

   Number, name, city and principal investigator. More sites are added in “Sites and team”.

A study can also be created from a protocol draft in YouEDC Studio (“Protocol to study build”): it gets the draft's visits, forms and fields instead of a template.

The creator becomes the study manager. A new study is “Setting up”: the overview lists the steps left before launch.

Limit. The Portal Owner may cap the number of studies per user. If the “New study” button is gone, the function is switched off.