5 Documents Critical for Medical Imaging Clinical Trials

Colin G. Miller

Clinical Data Management (CDM) is a critical part of clinical research. CDM leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. When it comes to clinical trials that rely on imaging endpoints, there are additional complexities with regards to data acquisition, analysis and export. These present challenges for sponsors, sites and data managers. As such, sponsors usually turn to an Imaging Core Lab (ICL) to quality check and independently review images from a clinical trial in support of regulatory approval. 

Here are five important documents (generated in conjunction with an imaging core lab) to help ensure high-quality imaging data from your clinical trial. Whether you’re a data manager, a sponsor or an investigator, knowledge of these documents will contribute to a smoother CDM process. 


1-Imaging Review Charter (IRC) 

Clinical trials with imaging endpoints require an IRC. The IRC serves as a roadmap for standardizing and interpreting data coming from trials containing imaging endpoints. Charters provide a comprehensive and detailed description of the clinical trial imaging methodology and the key assessments that will be exported from a study.  

In 2018, the FDA released guidance entitled Clinical Trial Imaging Endpoint Process Standards Guidance, which details the structure and content of an IRC.  Imaging Core Labs have expertise generating IRCs and work with sponsors and regulatory agencies to make sure that they contain the correct elements for compliance. From a data management perspective, the IRC identifies the overall flow of data for the trial. 


2-Business Requirements Specification (BRS) 

The BRS formally documents the existing business needs and defines how to meet these needs. It is a critical part of the overall project documentation and must be distributed, understood, controlled and managed during a trial. 


3- Electronic Case Report Form (eCRF) Review 

The eCRF is an auditable electronic record of information that is reported to the sponsor on each trial subject, according to clinical investigation protocol. For clinical trials using imaging endpoints, the eCRF is directly associated (and displayed) within the imaging review system and is used by independent reviewers to capture the required information and data from medical images for each study subject. The eCRF review summarizes the details of the imaging eCRF agreed upon by the sponsor and imaging core lab prior to the start of the trial. In some cases, the eCRF review may take the place of the BRS with respect to sponsor review. 


 4-Reviewer Rules 

Different clinical trials use different reader paradigms, ranging from a relatively straight-forward single reader to more complex paired reads with adjudication. The choice of reading paradigm is based on a number of factors. This includes: 

  • Study phase 

  • Regulatory compliance 

  • Operational efficiency  

  • Cost-benefit 

By understanding the selected reader paradigm, data managers can understand the flow of data in a trial and anticipate the amount of data they will be handled throughout the course of the trial. The reviewer rules document guides, independent reviewers, by providing necessary details for the accurate analysis of imaging data. Some studies may also contain an Imaging Atlas, which further defines the imaging endpoint and serves as a guide for independent reviewers. 


5-Data Export Specifications 

Ultimately, the data associated with a clinical trial will be exported in preparation for sponsor review and regulatory submission. Data export specifications define the exact requirements, format, and conditions of the data that are derived from medical images. Imaging core labs have SOPs and policies in place for data export and ensure that all patient information associated with trial data is encrypted and delivered electronically to the sponsor in a secure manner.  To help ensure the accuracy of imaging data, it is important to ensure that the Imaging Review Charter and export specifications document match with respect to the primary endpoints. 

Careful planning and implementation of key clinical trial documents will prepare sponsors, sites, data managers, and imaging core labs for handling complex data derived from medical images in clinical trials.  


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