Managing Sites to be Used on One or More Studies - Within a Given Host
The Site Manager is where sites are first added in order to use them on studies. Sites automatically become part of study when at least one user is added to the site.
Table of Contents:
Prerequisite: User has Host level access to the Site Manager, along with permissions to add and edit sites.
Adding New Sites
To add a new site to the Host, open the Site Manager within either the web or mobile app.
A list of existing sites will be displayed, including a link to add new sites. To add a new site, complete the form provided.
Site Name - How you refer to the site.
Site ID Number - This is an identifier of your choosing that might be used in the subject profile IDs (if the study is set up to use it) and the data extracts.
Site Type - There are two types of sites in TrialKit. Provider and Administrative.
Most sites in a study are "Provider" sites (real live sites that enroll subjects in the study). Provider sites are forced by the system to follow the rules of enrollment. For instance, a study must be published and live before provider sites can enroll.
The other option, "Administrative" sites, can be used for testing purposes, where a study in development might need to enter some test records at an Administrative or testing site. Normally, only one Administrative site is needed per study.
Dynamic CA's - In most cases this will be "Yes." Selecting "No" prevents all dynamic form logic from occurring for sites that have very little bandwidth (very rarely used). If "No" is selected, the study builder needs to keep this in mind when creating the study forms.
Making a site available for use in a study
When a new study is added, for it to be accessible at the study level, the applicable studies must be included. This feature helps maintain a focused list of sites rather than listing every site within the host account - some of which might not apply to a certain studies.
Currently this is only enforced on the mobile app. The web browser will make all sites available automatically to choose from at the study level.
This is done by tapping a site to open it's details and enabling the applicable studies:
There may be a need to deactivate a site without removing all the users. This could be due to a safety hold or data review, for example.
When this is done, the site is still accessible in the subject manager, and data can still be accessed for reference, but the data cannot be updated.
Deactivating a site can be done from the table of sites within the Site Manager.
Adding A Site to a Study
Prerequisite: User has access to Study Configuration - Configure Sites and Users
Once the site is available to use, it can be assigned to any study within that Host account. This is done by adding at least one user to the study within the Study Configuration settings, and making sure the site is included in the applicable study version.
For more information on adding users to sites, read about User Management.
The last step for new sites is ensuring the site is part of the applicable study version. This is done via the Version Manager.
All changes made on sites and users will be traceable in the Site/User Audit Report.
For a comprehensive report displaying all users, which sites they belong to, and which roles they have in the study, see the Site by User Report.