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
    • Configuring Study Start-Up Settings
    • Adding Countries
    • Adding IRB/ECs
    • Setting Required/Essential Documents for Countries
    • Setting Required/Essential Documents for IRB/ECs
    • 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:
    • Principal Investigator and other contacts
    • Start-up Specialists
    • Regulatory Approvers
    • 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.