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:
- 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
- Inviting users to the study room
- Creating/Editing/Viewing/Deleting Sites
- Adding contacts to sites. This includes adding:
- Principal Investigator and other contacts
- Start-up Specialists
- Regulatory Approvers
- Site Activation Specialists
- Sending Regulatory Packets and Submission Packages submit to IEC
- Collecting Essential/Required documents for sites, countries, and IRB/ECs
- Review of documents by a Start-up Specialist
- Review of documents by Regulatory Approver
- Site Activation and publishing documents to the eTMF
- Adding essential/required documents after site activation through
amendments
Each of the processes mentioned above are discussed in detail in subsequent sections.