Update a kit type during the study conduct period

Some fields for a kit type are editable, even during the study conduct period. If you need to update a read-only field, you must create a new kit type and use it to replace the kit type with the inaccurate field. 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. Update the kit type.

   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 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

Tasks include:

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. Generate a randomization list or upload a randomization list and generate a kit list or upload a kit list for Production and Training modes.
5. 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.
6. Update sites so that they are assigned to the new study version.
7. After sites are no longer using the previous study version, archive the study version.