Study Startup Process in Trial Interactive

  1. Adding contacts to sites this includes:
    • Principal Investigator and other contacts
    • Start-Up Specialist
    • Regulatory Approvers
    • Site Activation Specialists
  2. Sending Regulatory and Submission Packages.
  3. Collecting Essential/Required documents for sites, countries, and IRB/ECs.
  4. Review of documents by a Start-up Specialist. Translate documents to the local language if required.
  5. Review of documents by Regulatory Reviewer.
  6. Site Activation and publishing documents to the eTMF.
  7. Adding essential/required documents after site activation through amendments.