Upon registration, an account is created. In Clinical Studio, this is called a Website Host. A single email address can be used to register any number of times. Each subsequent registration will create a new Website Host account for that user.
Each user account in Clinical Studio is identified by an email address. A valid email address must be provided since the initial system-generated password, required to gain access to the system, is sent to this email address. Upon initial login to the system, the user is prompted to change the password.
A Website Host is the primary “organizational unit” in Clinical Studio. It has a specific monthly subscription plan associated with it. Each Website Host has at least one user account associated with it. When a user first signs up for Clinical Studio, the system creates a Website Host (account) for that user. This user automatically becomes Administrator of the new Website Host. Using the new free account (Website Host), the user is able to then build and manage as many studies as needed. The account will remain free indefinitely as long as there is only one user. As soon as a study is ready to be deployed, or more users need to access the studies, the original user will upgrade the subscription plan and add the other users simply by using their email addresses. The system will automatically send those users their login credentials. Those users will now have access to the Website Host and whichever studies they are a part of.
A company may choose to create multiple Website Hosts as a way to organizationally divide different business units or therapeutic domains within a company. For example, a CRO may choose to create a separate Website Host for each sponsor with whom they work. When engagement with that particular sponsor ends, the CRO could choose to retire that Website Host account.
An individual study builder may choose to create a Website Host for each sponsor for whom they build a study and then turn it over to the sponsor. They would accomplish this by elevating another user(s) to the Administrator role, updating the subscription payment module, and then being removed from the Host.
Relationship between user account and Website Host
A user account can be associated with any number of Website Hosts. If a user (identified by a unique email address) created in a particular Website Host already exists in one or more Hosts, Clinical Studio will recognize that and notify the user via email that they have been added to another Host. If a user account is associated with multiple Hosts, a dropdown list in the “Sign In Status” panel will allow the user to switch between them. The security roles within each Host account are independent of one another; a user could be administrator in one Host and a restricted user in another Host.
The Administrator role is the highest user role within a Host. The user that initially signs up for a Host account is automatically an administrator for that account. That user role can then assign other users within the Host to also be Administrators. In this way, a Host is not tied to any particular user, but can be transitioned to one or more users. A user with the administrator role is able to manage other user accounts, sites, studies and the theme. One administrator user is also associated with the billing module, administered through our eCommerce payment partner. This is a very important user (aka email address) since any failure with billing will send an email to this address. Repeated billing failures will result in suspension of the Host account and eventual deletion of all associated data if not remedied. Therefore, it is very important to update this email address with our eCommerce payment partner if that user is no longer associated with the Website Host.
A study is associated with a Host account. An account can have an unlimited number of studies associated with it. The subscription level dictates the number of users a Website Host is allowed. Within this limit of users, a Host can have an unlimited number of studies associated with it and divide the users up in any combination of ways among those studies. Each user can belong to any number of studies. A study can also have a sponsor name label, which will show up in the “Sign In Status” panel. This sponsor name is simply an informative label; it has no organizational purpose. It is useful for Website Host accounts that are hosting studies for more than one sponsor. If left blank, the Sponsor name defaults to the Website Host name.
There are two types of sites that can be created in the system. A Provider site is what would be considered a “normal” site, entering study data. An Administrative site is meant to be used for testing purposes. There needs to be at least one Administrative site created within a Host.
There are two types of roles that can be created in the system. An Administrator role spans across all sites. A Site role is limited to one site. This has implications for email notifications and query deployment only.
Roles and Security
When the first study is created within a website host, the system provides a ‘Default Study’, which is merely a study pre-configured to serve as an example. This prevents new users from needing to start from a blank canvas. The roles present in the default study are: Data Coordinator, Principal Investigator, Monitor, Data Manager, and Administrator. Each of these roles comes with a default set of rights which allows them certain functionality within the system. These default rights can be updated as well as entirely new roles created to suit the needs of a particular study.
Study Creation and Copy
Each new study in Clinical Studio is created by copying from an existing study. The first study created in a Host account is copied from the system default study. Subsequent studies can be created by copying from any existing study within the Host account. This allows users to deploy new studies by reusing existing CRFs, Conditional Actions (edit checks), custom roles, etc. Users can create their own study templates for standardization and rapid implementation.
Another unique feature of Clinical Studio is the ability to copy studies between Website Hosts. This allows for CROs, Sponsors, Investigators, etc. to transfer study metadata (CRFs, Conditional Actions, custom roles, etc.) and also study data at the conclusion of a study to facilitate, among other things, collaboration, additional analysis, transfer of responsibility.