Are you ready for the new version of ICH E6 Good Clinical Practice for Electronic Records?
By Deb Bartel,
This post was recently updated on September 19, 2018
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
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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