Update the way that subjects titrate during the study conduct period

Depending on the changes you need to make, you might be able to update the existing kit type titration, or you might need to create a new kit type titration and use it to replace the current kit type titration. These procedures also apply to rollover studies.

Task 1   Create a new Draft version of a study

Create a new study version in Draft so you can edit your study's design. For step-by-step instructions, see Create a new Draft study version.

Task 2   Update the Draft version of the study

1. Determine the scope of your changes:
   • You can update the name and settings for a kit type titration at any time.
   • To add or remove kits, you must create a new kit type titration.
   • To update the visits in which subjects can titrate, you might not need to create a new kit type titration; it depends on how you set up the study:
     • When you dragged the kit type titration to a visit and filled in the fields in the Add Titration to Visit Schedule pop-up, if you selected Dispense for the visit and left Allow Titration deselected, all you have to do is select Allow Titration and then make the new study version live.
     • If you didn't select Dispense for the visit, you'll have to create a new kit type titration.
2. If you created a new kit type titration, remove the existing kit type titration from all visits, and associate the new kit type titration with all appropriate visits.

Task 3   Make the new study version live

Tasks include:

1. Make a study live
2. Verify the study
3. Approve the study version. For more information, see Make a study version available in Production and Training modes.
4. Assign the randomization list to the appropriate study version in Production and Training modes. For more information, see Assign a randomization list to a randomization design and study version.
5. Update sites so that they are assigned to the new study version
6. After sites are no longer using the previous study version, archive the study version.