The Study Start-Up Process in Trial Interactive

The sequence of steps listed below gives you a glimpse of the study start-up process followed within Trial Interactive:

1. Setting up the configurations
   1. : Configuring Study Start-Up Setting
   2. Adding Countries
   3. Adding IRB/ECs Setting Required/Essential Documents for Countries
   4. Setting Required/Essential Documents for IRB/EC
   5. Setting Required/Essential Documents for all sites in a study
2. Inviting users to the study room
3. Creating/Editing/Viewing/Deleting Sites
4. Adding contacts to sites. This includes adding:
   1. Principal Investigator and other contacts
   2. Start-Up Specialist
   3. Regulatory Approvers
   4. Site Activation Specialists
5. Sending Regulatory Packets and Submission Packages submitted to IEC
6. Collecting Essential/Required documents for sites, countries, and IRB/ECs
7. Review of documents by a Start-up Specialist. Translate documents to the local language if required
8. Review of documents by Regulatory Approve
9. Site Activation and publishing documents to the eTMF
10. Adding essential/required documents after site activation through amendments

Eachof the processes mentioned above is discussed in detail in subsequent sections.