Extend the treatment period for subjects during the study conduct period

To extend the treatment period for subjects, you must insert new visits (and forms, if required) to the study. These procedures also apply to rollover studies.

Caution:

Consider the following recommendations when modifying the visit schedule of a live study:

• Do not re-order visits in a schedule that is already running in a live study version. This will not only affect the schedule of your study, but may also interfere with site users' data collection tasks.
• Do not delete a visit from the schedule of a live study version and then re-create it with the same visit title. Even though the newly created visit has the same title as the one that you deleted, visits will have different system IDs associated with them. This might affect custom JavaScript rules and data collection.

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. Create the visit that you want to include in the new Draft version of the study. For step-by-step instructions, see Visits and schedules.
2. Next up, add forms and schedule the visits. If you plan on assigning kits, you must also define dispensation. For step by step instructions, see the following:
   • Add a form to a visit
   • Define the visit schedule
   • Define the dispensation schedule
3. Make a study version available in Testing mode.
4. If you plan on assigning kits, you must check whether the kit list has enough kit numbers to continue dispensing. If not, generate a kit list or upload a kit list with additional numbers for Testing mode.
   • If you uploaded the original kit list, you must upload a new kit list. Make sure the kit numbers and sequence numbers don't overlap with the original list.
   • If you generated the kit list, you must generate a new kit list. Make sure the kit numbers and sequence numbers don't overlap with the original list.

Task 3   Make the new study version live

Perform the following tasks in the order below:

1. Verify the study.
2. Approve the study version. For more information, see Make a study version available in Production and Training modes.
3. If needed, upload or generate new kit lists for 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.