Studies contain sites

A site is the location where users collect study-related information. Sponsor users, such as medical monitors and clinical data managers, review the information and issue queries. Site users, such as investigators and clinical research coordinators, answer the queries and sign off on the items, forms, visits, and patients. Sponsor representatives then use the information to generate reports for publication or to fulfill regulatory requirements.

You add sites one site at a time. For more information, see Adding and editing a site. If you need to add many sites, contact your project manager.

You can add a user to individual sites or all sites, including new sites that are added to the study. Users can work only with patient and visit data collected at their assigned sites. For example, an investigator who works at only one site is assigned to that site and has access to the data for only that site. A medical monitor who has to review data across several sites is assigned to those specific sites and can see only data for those sites.

When a user is assigned to a site, the data that a user can view and edit is determined by the role to which the user is assigned. For more information, see:

• Assigning rights to a role.
• Assigning a user to a role.