The Site Manager is where sites are added to the account (host) and also where the sites are distributed to the studies that exist on the account. This article covers both those steps.
Open the Site Manager from Host Management in the main menu.
A list of all the current sites in the study will open.
To add a new site, tap the link above the site list, or tap an existing site to change any details, including which studies it belongs to, as highlighted below.
Here are some definitions for the screen seen in the image above.
- Database ID - A database identifier which is only seen in the study data extracts for submission purposes. This cannot be changed.
- Site Identification number - Most studies use site identifiers rather than the site name itself. That identifier can also be used in the subject profile ID numbers when patients are enrolled at that site.
- Site Type - Choose between Administrative or Provider. Administrative sites are for testing the study and are not controlled by the study status. In most cases, only one of these sites is needed. Most sites will be Provider sites where actual patient data is collected.
- Dynamic Conditional Actions - In most cases, this will be Yes. Selecting No prevents all dynamic form logic from occurring for sites that have very little bandwidth. If No is selected, the study builder needs to keep this in mind when creating the study forms.
- Activate/Deactivate Site - This can be used to instantly freeze a site from accessing the studies it is part of in TrialKit.
- Site Studies list - This is a list of all studies on the account, as created in the Study Manager. Use this list to enable which studies need access to the current site being edited. Keep in mind, this does not automatically give a site access. It will need actual users attached to it first. Read about that here.
- Save Site button - Be sure to save any changes.
There is a comprehensive audit trail report for all actions taken to add or remove sites and users from a study. This is of great importance for FDA compliant data.