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Testing cases for CRF edit checks

A case report form (CRF) is a document that captures and stores data in pharmaceutical and medical device clinical trials following the Title 21 CFR Part 11 guidelines.

Each time there is a need to implement any changes to a CRF, a new version is created in Study Designer(SD) and you can upgrade your sites, subjects, and study to the latest CRF version in EDC.

The CRF configuration is complex due to many dependencies, special logic, and other rules configured for form behavior that satisfy sophisticated data collection processes in clinical trials. Thus, in SD, along with designing a CRF, you configure specific rules that result in a list of edit checks that must be run for the CRF upon data entry to check if the stated logic and dependencies work correctly.

For instance, when entering data into the "Demographics" CRF in EDC, the question "Pregnancy test" must only appear if the subject's sex is stated as female. Thus, if the DM enters the "Sex" value as "Male" and the "Pregnancy test" question does not appear in the form, the test case is considered passed successfully.

In EDC, you can generate and run testing cases for your configured CRF versions in the test—UAT—lifecycle before pushing the newest version and initiating actual data entry in the production—PROD—lifecycle. This helps you prepare the fault-free CRF version and avoid situations of broken logic only outing when the actual data entry starts.

in the test—UAT—lifecycle before pushing the newest version and initiating actual data entry in the production—PROD—lifecycle.

Such a test run helps the data manager (DM) team generate the summary of the incremental CRF changes—the differences between the latest and the currently effective CRF version on PROD—and assess how clean the results are, and if the version is ready to be used in a study or if the fixes must be applied to the CRF rule design in SD.

Important

The functionality to run testing cases for CRF edit checks is only available in UAT, as it is a testing lifecycle for your study configurations.

In this section, you can learn how to do the following:

In this section:

An eClinical application that provides functionality to design and configure a study (clinical trial), namely to configure CRFs, set subject phases, visits, and others.

The application supports the design of the CDSIC ODM-compliant electronic CRFs to support EDC and eDiary data collection and management.

Get to know all the possibilities of the app with the comprehensive SD User Guide.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

In eClinical, an environment that is designed to support a clinical trial development process, for instance, DEV for the development process, UAT for testing activities, and PROD for production.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.