Study Definition module
The MACRO Study Definition (SD) module is used to design, create and maintain studies.
Using this module, you will be able to:
Create new studies and edit existing ones
Create questions, question groups and eForms
Place questions and question groups onto eForms
Add lines, pictures, text, hotlinks and formatting to eForms
Create a schedule
Copy questions and eForms from the library and other studies
Set up question validation conditions
Create derived questions
Create skip conditions
Set up question authorisation (for electronic signatures)
Set up predefined Reasons for Change and Reasons for Overrule
Monitor required questions
Set up the validation of laboratory test results
Set up subject registration
Attach references and customised reports to your study
Each user is assigned access rights by the system administrator. This takes place in the System Management module. These access rights are completely flexible and can be set up in the way that best reflects the practices of individual organisations. This allows users to be given access rights to reflect their exact roles, rather than being restricted to the standard roles within the industry.
MACRO works with the ALEA service from TENALEA to provide subject randomisation for studies.