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Push CRF version to PROD

A CRF stands for case report form, a document used in clinical trials to collect and record study data. As the trial evolves, new insights or challenges may emerge, requiring changes to the CRF. These modifications, especially after data collection has commenced in the EDC system, lead to what is known as versioning. This process involves adapting the CRF to new protocol requirements or data collection processes during the clinical trial.

When maintaining CRF versions, you have the option to advance the submitted version from the UAT lifecycle, where it is rigorously tested, to the PROD lifecycle. Once in the PROD lifecycle, the CRF can be actively used for real data collection. The transition to the PROD lifecycle indicates that the CRF version has passed all necessary validations in the UAT lifecycle and is now fully compliant with the study protocol.

CRF version push to PROD as part of full lifecycle
Figure 1. CRF version push to PROD as part of full lifecycle

Important

To push the CRF version for a substudy to another lifecycle, ensure that the master study CRF version is already pushed to that target lifecycle, otherwise, you cannot complete the procedure.

To push a CRF version to PROD

  1. In the Study Designer application header, select the VERSIONING tab.

  2. From the workspace toolbar of the Version Information table that appears, select the UAT lifecycle and needed role.

    Selecting UAT lifecycle
    Figure 2. Selecting UAT lifecycle

  3. In the Version Information table, next to the active CRF version, select button_push_PROD.png.

    Important

    When pushing a CRF version for a substudy to another lifecycle, the system checks if the master study CRF version is already pushed to that target lifecycle. If not, then the error message appears and you cannot take further actions of the procedure.

    Selecting to push CRF version to PROD
    Figure 3. Selecting to push CRF version to PROD

  4. In the Signature info dialog that appears, select button_sure.png to confirm that the necessary CRF version signatures have been submitted in the UAT lifecycle.

    Confirming CRF version signatures
    Figure 4. Confirming CRF version signatures

    Tip

    The CRF version can be signed by a clinical trial manager or a regulatory affairs specialist before it is pushed to the next lifecycle.

  5. In the Push to PROD dialog that appears, enter a comment explaining the reason for pushing this CRF version to the PROD lifecycle, and then select save_button_red_white.png.

    Confirming CRF version push to PROD
    Figure 5. Confirming CRF version push to PROD

Once saved, the CRF version is pushed to the PROD lifecycle. You can now publish this version to EDC to use for data collection.

In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

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

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.