Study Startup Process in 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.