# Managing Site Feasibility in Study Startup

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.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: This feature is only available on Clinical Operations Study Startup Vaults.</p>
    </div>
  </div>
</div>



## Default Configurations

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 <a href="/en/gr/13951/">_Location_ object record</a>
.

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][4] 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 <a href="/en/gr/31637/">_Person_ object record</a>
.

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 <a href="/en/gr/4345/#study_sites">_Study Site_ object record</a>
.

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_:

  * _Candidate*_
  * _Qualifying*_
  * _Qualifying Hold*_
  * _Initiating*_
  * _Initiating Hold*_
  * _Active_
  * _Closing_
  * _Closed_
  * _In Migration_
  * _Archived_
  * _Inactive_
  * _Not Selected*_

_*_ Also used in Study Startup

When using lifecycles, you must <a href="/en/gr/30683/">initiate a user action</a>
 or <a href="/en/gr/33550/">initiate a workflow</a>
 on each record to change its state.

### Site Feasibility Workflows {#workflows}

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 <a href="/en/gr/40757/#clinical-user-tasks">Clinical User Tasks</a>
, 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.

 [4]: #workflows