Flatiron vs. Traditional EDC

The Flatiron system is considered a “Next-generation” EDC system and takes a novel approach to many of the common tasks that site and sponsors are required to do. In addition to traditional EDC functionality Flatiron introduces a number of new concepts that we will briefly cover here.

Protocol Notices and Guidance

Notices are read-only informational messages that are visible to all users. They are available at the visit and procedure level to serve as a reminder of how or when the visit or procedure should be conducted.

Guidance are actionable messages providing step by step instructions on how a procedure should be performed. They serve as a checklist for site personnel and CRAs to ensure protocol compliance and consistency across sites and subjects.

Saving vs. Submitting

Saving: Data and uploaded documents are immediately and automatically saved as they are entered. There are no save buttons that need to be clicked in order to preserve data.

Submitting: Submitting should be done when all data is entered and any necessary documents have been uploaded to a procedure and the procedure is ready for CRA review. Once a procedure is submitted it will be in read-only mode preventing any updates while it is being reviewed. A site user can re-open a procedure for editing at any time prior to it being marked as Reviewed by the CRA. A CRA can re-open the procedure at any time if it is determined that updates are required.

Upload of Source Documentation

Flatiron allows for the upload and storage of source documentation at the procedure and log level. This allows for source documents to be identified and located one time and then permanently attached to the correct visit and procedure, Site Log or Subject Log row within the system.

Once the source has been uploaded the procedure can be viewed in “splitview” mode where the source is displayed on the left half of the screen and the data entry fields on the right half. Having the source available in this manner adds for greater efficiency in data entry but also allows for remote monitoring and source data verification.

Not Done Workflow

The system provides a built-in workflow to handle visits, procedures, and individual measurements that were not performed. Anytime one of these items has been marked as “not done”, the system will prompt the user to provide the reason why it wasn’t completed. The reason is stored as a log entry in a protocol defined subject log (e.g., Protocol Deviations Log) and a permanent association is made between the item marked as not done and the log entry.

Potential Clinical Significance

As data is being entered, individual measurements can be automatically flagged as being Potentially Clinically Significant (PCS). A value may be triggered as being PCS when it is outside of normal range or has changed a specified percentage since baseline. Any values that have been marked as PCS will have a visual indicator on the data entry screen.

The system then provides a separate PCS workflow where the Study Coordinator and/or Principal Investigator can address each flagged item. Each item can be marked as being clinically significant or not clinically significant. Based on the categorization the item can be associated with a specific subject log entry (e.g, Adverse Event, Medical History).

Log States

For log entries where all the information may not be available at the time the entry is created, the system will display a contextual aware state to let the site and sponsor know if data is currently missing. States eliminate the use of unnecessary missing field edit checks.

States are configurable per log type. For example, an Adverse Event entry may go through the following states from the time it occurs until it is resolved: Reported, Ongoing, Complete. Between states, the entry will be labeled as “Data Incomplete” indicating that there are fields that need to be entered in order to move the entry to the next pre-defined state.