Documentation in Imaging Clinical Trials: Its Importance and Recent Regulatory Changes

Brett A. Hoover and Karla Schmidt |

While process and documentation may not seem sexy or exciting to many of us, they are still critical to your study’s success. Like a puzzle, we can’t see the full picture until these important pieces are in place.

This is particularly true when clinical trial designs include imaging endpoints. When a clinical investigation protocol includes imaging, not only do operational risks increase, but the importance and burden of study documentation is also heightened.

Start with the right documentation for clinical trial imaging successWhy is Documentation So Important?

Within the confines of an imaging clinical trial, well thought out documentation serves a number of important functions, including:

1. Documentation is a compliance requirement mandated by many regulatory agencies.

2. Imaging documentation ensures that study stakeholders have thought through the critical elements (and risks) of an imaging study, and that these elements (e.g., process, workflow, technology requirements, communication plan, risk management, etc.) are formally captured and clearly communicated.

3. Imaging documentation sets the foundation for how imaging will be performed and managed, and enables process compliance and data quality continuity as study staff and other stakeholders turn over throughout the study lifecycle.

Through a strong documentation process and quality foundation, study stakeholder can more quickly identify and efficiently resolve the unexpected challenges that are inherent to running an imaging research study.

Regulatory Guidance: What’s changed?

In April 2018, the U.S. FDA released an updated version of its Guidance for Industry, Clinical Trial Imaging Endpoint Process Standards. Although updates like these typically provide clarity to pre-existing guidance, this particular update could also pose additional challenges. This is because some of the updates suggest changes to the terminology and definitions of various documents which comprise a study’s Imaging Charter.

As a refresher, the Imaging Charter is the over-arching document which defines how imaging is performed and managed within a clinical trial. Table 1 presents 3 examples (not exhaustive) of the documents comprising a study’s over-arching Imaging Charter that the FDA suggests re-naming.

Configuring an effective imaging management solution that generates high quality endpoint data and ensures compliance with process, quality and regulatory standards starts with developing the right imaging documentation for your study. It is from this critical document foundation that all other aspects of your imaging study are derived.

This is also why document development cannot take place in a vacuum, and why your imaging vendor must develop your study documentation in close collaboration with your study’s science, technology, medical and operations stakeholders.

In short, to ensure your study’s success, make sure you have all the pieces needed to complete the clinical trial imaging puzzle – beginning with your study’s imaging documentation.


Read earlier installments to this series, including Understanding the Blinded Read and Overcoming Data Management Complexities in Medical Imaging Clinical Trials.’


Brett A. Hoover is the Director of Imaging Product Management at ERT and Karla Schmidt is a Manager of Integration, Imaging Operations at ERT.