Home
Study Start-Up
The Start-up module is available to users who have the Study Start-up action selected in the user profile, who are members of the data room’s Study Start-up Team group, and who are Start-up Specialists in the data room.
The Study Start-Up Process in Trial Interactive
The Study Start-Up Module
Countries
Amendments

Amendments

After a site is activated and the clinical trial begins, it is widespread to have amendments to the study protocol; depending on the nature of the amendments, many more essential/required documents need to be submitted by the sites. Such documents cannot be added to the site directly and can be specified only through Amendments. Amendments can be created for Investigative Sites, Country Amendments, and IRB/EC.