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CRF post production changes

Post-production change (PPC) is a clinical data management term that usually implies changes to the visit structure, form fields, or CRF edit checks. These changes can be attributed to planned or unplanned updates. Planned PPCs refer to study-specific updates known by a clinical data manager in advance or specified in the protocol. On the other hand, unplanned PPCs are not included in the protocol but may be requested by the sponsor or due to important protocol alterations.

The review process usually takes place to have any post-production changes verified by clinical programmers and statisticians. This is done to ensure data integrity after it has already been collected and processed in the EDC application. After the updates to the CRF are made in Study Designer, the most recent CRF version becomes available for the PPC process in EDC in the PROD lifecycle.

PPC in EDC
Figure 1. PPC in EDC

The post-production change (PPC) process can be conducted in one of the following ways:

  • Scheduled to run the post-production update on a specific date.

  • Executed manually to run the post-production update immediately.

In this section:
clinical data manager

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

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.

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