The Study Start Up Process in Trial Interactive
The Study Start Up Process in Trial Interactive
The sequence of steps enlisted below gives you a glimpse of the study start-up process followed within Trial Interactive:
1. Setting up the configurations
a. Configuring Study Start-Up Settings
b. Adding Countries
c. Adding IRB/ECs
d. Setting Required/Essential Documents for Countries
e. Setting Required/Essential Documents for IRB/ECs
f. 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:
a. Principal Investigator and other contacts
b. Start-Up Specialists
c. Regulatory Approvers
d. Site Activation Specialists
5. Sending Regulatory Packets and Submission Packages submit to IEC
6. Collecting Essential/Required documents for sites, countries, and IRB/ECs
7. Review of documents by a Start-up Specialist
8. Review of documents by Regulatory Approver
9. Site Activation and publishing documents to the eTMF
10. Adding essential/required documents after site activation through amendments
Each of the processes mentioned above are discussed in detail in subsequent sections.