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.