available user profiles are:write access: Investigators and Study Nurses
read access: Monitors, Data Managers and Sponsors
All study end users can consult detailed training slide decks on their study home page.
2. Study structure
A study CRF is set up with visits that contain forms. The forms contain questions and/or labels.
The questions can have validation rules.
- Click on a form name to open the applicable form.
- Click on the form or visit name to create an instance of these form and/ or visit types.
3. Data Entryedc2go supports several question types:
- single line text or paragraph text
- date and time field
- multiple choice or radiobuttons
- dropdown lists
- document upload
All entered data in a form must be saved before moving to a next form.
users with Investigator and Monitor profile can sign CRF forms:
Data queries can be triggered by the system, depending on the designed validation rules and can also be created manually by users with a Monitor or Data Manager profile.
- Users with Investigator or Study Nurse profile can answer queries.
- Monitors and Data Managers can open, close and re-open queries.
6. Lock and freeze
Users with Monitor profile can freeze forms.
Users with Data Manager profile can lock forms.
Freeze and lock can be done per form or in batch (Patient level).