Don’t Overlook Annex 2: RWD and DHT Data Are in Scope for Retention

ICH GCP E6 (R3) Annex 2 brings to light the increasing role of decentralised trials, digital health technologies (DHTs), and real-world data (RWD) in clinical research. However, it’s important not to view Annex 2 in isolation. If we also turn our attention to Annex 1 we can see that data generated from DHTs and RWD is within the scope of retention requirements, and ensuring the integrity and usability of this data throughout its lifecycle is important for verifying trial outcomes. 

RWD and DHT Data Are Essential Records

Annex 2 brings RWD and DHT data into the scope of essential records that must be retained. Under ICH GCP E6 (R3) Appendix C2.6. Sponsors and investigators are reminded to retain records in a way that ensures they remain complete, readable, and accessible for regulatory review. Essential records include data generated by decentralised trials, such as ePRO (electronic patient-reported outcomes) and data from wearable devices, sensors, and other automated instruments. Overlooking regulations such as Appendix C2.6 (and EC 536/2014 Article 58) risks non-compliance and challenges during regulatory inspections. 

Key Challenges in Retaining RWD and DHT Data

Retaining real-world data (RWD) and data from digital health technologies (DHTs) isn’t as straightforward as it might seem. Firstly, many wearables and sensors store data in proprietary formats and in vendor databases, making it difficult to ensure future readability and access.  

The challenge doesn’t stop at proprietary formats. Many systems come with restricted export capabilities. This creates major challenges for effective data migration and archiving, especially when dealing with large volumes of data, from multiple sources. 

Without foresight, transitioning data out of these proprietary systems can turn into a costly nightmare that risks compromising data integrity. Address these challenges during the early stages of study planning and vendor negotiations. By thinking ahead about data portability and access, researchers can protect the long-term value of their RWD and DHT data, ensuring it remains a useful resource throughout its entire lifecycle. 

Conclusion – Plan Ahead: Don’t Let Retention Be an Afterthought 

As with all essential records it is important to take a pro-active approach and plan ahead, this can include reviewing file formats, ensuring the data can be migrated, checking data integrity and creating a clear exit strategy.   

Additional resources are available to support alignment of ICH GCP E6 (R3) such as the GAMP Good Practice Guide: Computerized GCP Systems & Data (2nd Edition). This resource provides actionable insights for managing GCP-compliant systems and ensuring retention requirements are met.