General

To configure the General Settings, follow the steps below.

1. Navigate to the Study Settings screen and click on the ‘General’ link from the left-hand navigation pane.

2. Click on the Edit button from the top menu bar.

3. Expand the following sections and configure the necessary settings.

4. General Settings: On the General Settings screen, configure the following settings.

   1. Subject Tracking
   2. Is this a blinded trial
   3. Always use Study Specific Settings
   4. Site Visit Documents Date Format
   5. Site Visit Documents Date Time Format
   6. eTMF Location
   7. Planned Tracking Fields
   8. Subject Date of Birth Tracking
   9. Subject Date of Birth Format
   10. Site numbering
   11. Type
   12. Start from
   13. Size
   14. Site Auto-numbering Rule

       

5. Publish Study: The Publish Study section allows users to publish a study in a draft state. To publish a study, click on the Publish Study button. On the confirmation popup click on the Publish button. Once the study is published, users cannot edit study information like Protocol Number, Study State, and Subject DOB definition.

   

6. Monitoring Information: Configure the following settings within the Monitoring Information section.

   1. SVR Submission Dates
   2. SVR Approval Days
   3. Site Visit Frequency

      

7. Reviewers: To add blinded and unblinded reviewers, click on the +Add button and select the reviewers from the available list.

   

8. Site Auto Naming Rules: To configure the site auto naming rules, double on a value to select from the list of available fields.

   

9. Once all the changes are made, click on the ‘Save’ button at the top-left of the window.