Often, the process of identifying, assessing, and selecting study sites can be drawn-out and frustrating. With the site feasibility feature in Study Startup, users can easily collect investigator and facility data and reuse and leverage that data to more precisely identify suitable site candidates for future studies. Site feasibility also includes processes to manage qualification and selection activities, and to collect key planning dates and performance metrics. These processes run seamlessly into activation activities for selected sites, reducing errors and increasing speed to study start.
Note: This feature is only available on Clinical Operations Study Startup Vaults.
The site feasibility feature includes the following standard configuration elements. Note that you can hide or inactivate fields if you do not wish to use them.
The Location & Facilities Information Objects
In the site feasibility configuration, the Location object has a child Facilities Information, which captures data about the site’s equipment and facilities, such as Imaging Equipment and Lab Tests. You can create Facilities Information object records from Admin > Business Admin or directly from a related section in a Location object record.
In Study Startup, the Location object also has additional fields to further identify potential candidates for clinical trial sites, such as Fast-Track Site?, Estimated Active Patients, and Therapeutic Expertise.
Note that when you set the Fast-Track Site? field to Yes on a given Location and link a Study Site site record to that Location, you can immediately start the Qualify Site workflow without conducting a preliminary site review. See workflow details below.
The Person & Credentials Objects
In the site feasibility configuration, the Person object has a child Credentials object, which captures data about a PI or SI’s background and experience, such as Education and Certifications. You can create Credentials object records from Admin > Business Admin or directly from a related section in a Person object record.
In Study Startup, the Person object also has additional fields, such as Debarred? or Total Trials as PI or SI to identify potential Principal Investigators and Site Investigators to lead clinical trials.
The Study Site Object
As you work through the site feasibility and selection process, Vault automatically populates fields in the Key Selection and Startup Details and Startup and Selection Metrics related sections of the Study Site object record.
For example, when you decide to proceed with qualification activities, Vault updates the Date, Decision to Qualify field with the date on which that decision occurred, as well as the Days, Decision to Qualify field with the total number of days that it took to qualify the site. Vault calculates the Days, Decision to Qualify field by calculating the difference between the Date, Site Identified and Date, Decision to Qualify fields.
Site Feasibility Lifecycle States
Vault includes the following lifecycle states for the Site Lifecycle:
- Qualifying Hold*
- Initiating Hold*
- In Migration
- Not Selected*
* Also used in Study Startup
Vault includes several workflows associated with the Site Lifecycle states mentioned above:
- Site Will Not Participate
- Place Candidate on Hold
- Remove Hold
- Conduct Preliminary Review
- Qualify Site
- Select Site
When a site’s state changes to Qualifying, Vault automatically creates milestones, EDLs, and Clinical User Tasks, which you must complete to fully qualify the site. Once the site is fully qualified, you can Select Site in the site’s Actions menu to associate the site with your study and begin site initiation.