Activate a site

To make a study version live, activate a site. Make a study live in Production mode only after the site has contractually agreed to the protocol and regional regulatory requirements are in place. A site that has been activated can never be deleted, but it can be retired. This procedure also applies to rollover studies.

Before you can activate a site, you must perform the following tasks in the specified order:

1. Add the site, including specifying the principal investigator's last name.
2. Assign a study version to a site.
3. Select a resupply strategy for each site.
4. Specify the first subject number for Testing mode in Study Settings.
5. Open the appropriate cohort(s).

• Depending on how supply settings are set up, site activation might initiate a shipment to the site.
• If you activated a site in error, or if a site is no longer active, mark the site as retired. You can activate a retired site at any time.

What if users have problems working in a live study?

Note:

You or your delegate are responsible for ensuring that appropriate regional and local regulatory approvals are in place before allowing a site access to any study versions that may mandate the conduct of specific procedures and investigations on subjects.

1. On the Home page, click the pencil button () on a study, and make sure the correct study version is in the appropriate container:
   • Testing for Testing mode.
   • Approved for Production and Training modes.
2. Open the study settings.
3. Click the Sites & Labs tab.
4. Along the top of the page, select a specific mode:
   • Production Sites
   • Testing Sites
   • Training Sites
5. Locate a site that you want to activate.
6. Next, from the Manage Sites drop-down, you can select either one of the following options:
   • Select Edit and in the Edit Site dialog, select Active from the Status drop-down and click Save and Close.
   • Select Activate.

Activate sites in other modes when required.

• Verify a study in Testing mode once you have activated sites and make your study live in Testing mode.
• Practice data entry in Training mode once you have activated sites and make your study live in Training mode.
• Manage real data and Work during the study conduct period once you have activated sites and make your study live in Production mode.