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. This procedure also applies to rollover studies.

A site that has been activated can never be deleted, but it can be retired. You can also activate a retired site at any time.

WARNING:

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.

Prerequisites:

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. (Optional): Select a resupply strategy for each site.

   Note:

   If your supply settings are configured to send initial shipment upon site activation, you must make sure to assign a resupply strategy to the site before its activation. Otherwise, the initial shipment will not be sent automatically.
4. Specify the first subject number for Testing mode in Study Settings.
5. (Optional): Open the appropriate cohort(s).

To activate a site:

1. On the Home page, click Edit 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.