System Navigation
System Navigation
Navigating the system is straightforward and after your first few uses, you should feel right at home getting around. We’ve highlighted the main screens within the application below as a jumpstart to orient you with where to find the major features.
Breadcrumb Navigation
The breadcrumbs navigation is one of the main ways that you will get around. The breadcrumbs serve three purposes:
- They act as a guidepost letting you know exactly where you are within the system.
- They offer a way to trace the path back to your original starting point. Clicking on any of the hyperlinked parts of the breadcrumbs will take you directly to that section.
- They let you know what version of the protocol is currently effective at a site as well as which version of the protocol was effective when a particular visit was started.
The format of the breadcrumbs in the Flatiron system is: Home / Protocol / Site / Subject / Visit.
**Use of your browser’s back button is not supported in the application and clicking it will not take you back to the previous screen like it will on a typical web page.
eProtocol
The eProtocol provides a read-only version of the key parts of the protocol necessary for a site to execute the trial. The information displayed and reference documents available in the eProtocol will always reflect the version of the protocol currently effective for a site.
Site View
The Site view is the central page for all details related to the site. Site logs are also accessed here to upload relevant site-wide documents.
Subject View
The Subject view is the central page for all details related to an individual subject. This page outlines the visit schedule and provides an overview of the CRA Review and DM Query statuses. The Subject Logs, Exception work flow and ICF work flow are also accessed here.
Procedure View
After selecting a visit the following screen will list all of the procedures (aka CRFs) that are scheduled to occur at that visit. Clicking on a procedure will display all relevant information and the data capture for that procedure. This is also where relevant source or study documentation can be uploaded via the Certified Copies “+Add” button.
Procedure View key:
- View and search All Certified Copies within a visit
- Visit Notice - Visit specific read-only informational messages
- Procedure Notice - Procedure specific read-only informational messages
- Procedure Guidance - Actionable messages providing step by step instructions on how procedure should be performed
- Source Guidance - Actionable messages providing instructions for uploading source
- Upload, view, and search Procedure Certified Copies
- Data Entry
- Data Quality Check workflows
- Missing Fields - notifies when data entry fields are empty
- Procedure Review
- Procedure Queries
Subject Logs
Subject Logs are used by a site to track subject information such as adverse events and concomitant medications that is not associated to a specific visit.
