Are you ready for the new version of ICH E6 Good Clinical Practice for Electronic Records?

R2 of E6 Good Clinical Practice has been published for consultation. Once approved, it will replace the original R1 version of E6.

What’s included in this revision:

E6 R2 contains updates intended to increase clinical trial quality and efficiency.  The objective of this draft ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical trial data.

Software and computer system topics include:

Section 1 – Glossary

Section 1 contains definitions of audit trail, certified copy, validation of computerized systems.

Section 4.9 – Records and Reports

Look here to read the expectations for audit trails for source data, source documents, trial records, and CRF changes.

Section 5.0.2 – Risk Identification

This section addresses the inclusion of risks associated with computer systems.

Section 5.5 – Trial Management, Data Handling and Record Keeping

Here you will find detailed expectations for computer system:

• Validation
• User training
• Audit trails
• Security
• Back ups
• Blinding
• Upgrades
• Data migration

Additionally, SOPs are expected for computer system:

• Validation
• Installation
• Maintenance
• Security
• Change control
• Backup/recovery
• Contingency planning
• Decommissioning
• Data management

Section 8 – Essential Documents

Section 8 discusses the expectation for easy retrieval of essential documents by both the sponsor and the investigator, whether paper or electronic.

Download the ICH Guideline here: E6 (R2): Good Clinical Practice

You may also be interested in the ICH E6 (R1): Good Clinical Practice fro 1997

Not sure what to make of this new revision? Talk to our CSV experts about how it may affect your computer system compliance