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