Simplifying Mid-Study Updates with Prelude EDC’s Protocol Amendment Module

By Editorial Team on March 12, 2024

In clinical research, it is crucial to be able to make protocol amendments quickly and efficiently to maintain the integrity and progress of ongoing studies. Prelude’s Protocol Amendment Module offers a seamless and user-friendly approach to managing protocol amendments within its Electronic Data Capture (EDC) system. When a protocol amendment is required, database managers can modify electronic case report forms (eCRFs) to dynamically display eCRFs based on a protocol version, preview and test those changes in their training database with their team, and push their amended eCRFs to the live database. The amended study eCRFs will appear per the protocol amendment’s effective date noted in Prelude, ensuring continuity of data collection and the integrity of ongoing research efforts.  

Breaking that down… 

Flexible Versioning System  

Researchers can choose a protocol versioning method that suits their needs, whether simple whole numbers (1, 2, 3, etc.) or decimals (1.0, 1.1, 2, etc.). Prelude EDC adapts to meet the unique requirements of each study. 

Automated Protocol Assignment 

Prelude simplifies the management of protocol amendments by automatically assigning all patients a protocol version number. By refining the criteria within the module, researchers can ensure that every patient receives the correct protocol version. This eliminates manual errors and discrepancies. 

Tailored Amendment Management at the Site Level  

The module offers amendments at the site level for studies with site-specific requirements, allowing for customized protocols based on individual site needs. 

Exploring the Protocol Amendment Module in Prelude EDC

1. Add the Protocol Amendment Module to Your Study Build

Database managers will want to add the amendment module to a study build before the study goes live. After going live, the module helps database managers implement and manage mid-study updates as they come.

2. Update Patient eCRFs

Before a mid-study update takes effect, database managers will specify the protocol version to which the change to the build applies. When all updates have been completed, the study team can view and test the changes to ensure they are aligned with the amendment before deploying to the live database and to confirm they do not erroneously impact any previously enrolled patients. 

3. Set the Protocol Amendment Effective Date 

Updated protocols can be uploaded to Prelude EDC. For each, the version and effective date are specified. Now, site staff can easily view every protocol version and updated documentation. 

4. Real-Time Updates 

As new subjects are added, Prelude automatically captures the current protocol version in effect at the site so that the eCRF is presented per the specifications in the latest protocol. 

In conclusion, Prelude EDC’s Protocol Amendment Module simplifies how researchers manage protocol amendments in live studies. By offering flexible versioning options, streamlining workflow processes, enabling form modifications, and providing site-level management capabilities, Prelude empowers researchers to implement protocol amendments quickly and confidently. 

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