Creating a study
Study or DM project; name, code, type, the first site.
“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.
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.
Study type
Registry, observational, retrospective, patient survey (ePRO) or clinical trial. The type drives hints and templates in the next stages.
First site
Number, name, city and principal investigator. More sites are added in “Sites and team”.
The creator becomes the study manager. A new study is “Setting up”: the overview lists the steps left before launch.