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Site Document Manager

Collecting Information Related to a Site in a Given Study

 

Prerequisite:  User has access to Site Documents

Purposes of Site Documents

Site Documents can be used for the following purposes, depending on user permissions:

Accessing Site Documents

Site Documents can be accessed from the Site Document Manager accessible via both the web and mobile app.

Web Browser:

Under the study menu:

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The resulting screen will provide access to applicable sites to which the user belongs.

  1. Access site documents via the links.

  2. Administrators can optionally define enrollment goals. Read more here.

  3. Administrators can set which local lab applies to which sites. Read more here.

 

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At the bottom of the page, Administrators can also define subject registration rules, whereby certain documents need to meet completion rules before the system will allow that site to register subjects.

 

Mobile App:

Within the side menu:

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This opens a list of sites to which the current user has access as shown below.

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Tapping a site opens the list of site document forms for which the user has viewing permissions as shown below.

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Site Document Administration

Site forms are built using the Form Builder, exactly like subject eCRFs are built. Once built, they can be set up as one-time collections or as log forms to collect recurring data from sites. Site users who have permission to access Site Documents will only see the forms for the site(s) they belong to, as shown above.
 

Defining Site Rules For Enrollment

If there are specific requirements that need to be met by a site before the site can register new subjects, TrialKit can help enforce that rule. With nothing set, the sites will be able to register subjects at anytime as long as the study is in Live status.
There are two options for enrollment rules:
  • When all site documents are completed
  • When a specific site document contains a date and checked box
It's not common that all site documents are needed prior to enrollment, so the more common option used in the second one above. With this an Administrator can have a form that only they have view access to - which can be used to enable individual sites for enrollment once they have reviewed the existence of necessary site documents (e.g. Training logs, CVs, IRB approval, etc).
To set it up, select the desired form, date field, and checkbox field to serve as the trigger:
 

An alternative to this is waiting to enable the site for the study version until a known milestone is reached.

 

Defining Site Enrollment Goals

Enrollment goals are the targeted number of Participants needed for each site individually. The goal numbers are also reflected in the dashboard report when computing the progress of subject enrollment.
The goals can be defined within the Site Document Manager:
If a Limit is enforced on the goal, the system will prevent registration of additional subjects beyond that number.