If you modify any kit type or advanced dispensation definition used in a live study, the updates will apply to all subjects for upcoming dispensations once the new study version with the updates is approved and assigned to the site.

Task 1   Create a new Draft version of a study

1. Create a new study version in Draft so you can edit your study's design. See Create a new Draft study version.

Task 2   Update the Draft version of the study

1. Access the Draft version of the study you just created. See Open a study's design.
2. Select Study Supplies.
3. Navigate to the Kits tab.
4. Locate the kit type or advanced dispensation to be updated and click the edit icon () to update it as needed:

   Note:

   Most fields are read-only. For instance, for investigational product kit types, you can't change the type, such as switching from a bottle to a blister pack, or the ID of the kit type. If you need to change a read-only field, create a new kit type.
   • For investigational products, see Define the kits for investigational products.
   • For devices, see Define the kits for devices.
   • For calculated doses, see Define kits with calculated doses.
   • For advanced dispensation, see Define advanced dispensation of kits.

     If you add a new group in the advanced dispensation definition, make sure to define a unique characteristic to differentiate the subjects in this new group from other groups.

Caution:

For titration studies: You will get notified if you edit a kit type that is used in a titration. Review the given titration and make sure your updates don't affect the titration definition, otherwise make the necessary changes. See Update the way that subjects titrate during the study conduct period.

Task 3   Make the new study version live

1. Make a study version available in Testing mode.
2. Verify the study.
3. Approve the study version. For more information, see Make a study version available in Production and Training modes.
4. Depending on the update you want to apply, for example if you created a new a kit type, add a new randomization list and a kit list in the given mode. Then assign the randomization list to the appropriate study version. See:
   • Generate a randomization list or upload a randomization list.
   • Generate a kit list or upload a kit list.
   • Assign a randomization list to a randomization design and study version.
5. Update sites so that they are assigned to the new study version. See Update the study version that is assigned to a site.
6. After sites are no longer using the previous study version, archive the old study version.