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:
- Add the site, including specifying the principal investigator's last name.
- Assign a study version to a site.
- Select a resupply strategy for each site.
- Specify the first subject number for Testing mode in Study Settings.
- 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- If you activated a site in error, or if a site is no longer active, mark the site as retired.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.- 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.
- Open the study settings.
- Click the Sites & Labs tab.
- Along the top of the page, select a specific mode:
- Production Sites
- Testing Sites
- Training Sites
- Locate a site that you want to activate.
- 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.
Parent topic: Make a study live