EMA E6(R2): Guideline for Good Clinical Practice, 7/15

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In July, 2015, the EMA published this consensus draft of ICH E6(R2) for consultation. The comment period ends in February, 2016.

The objective of this 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 data by the regulatory authorities in these jurisdictions.

This addendum to the version of E6 approved in 1996 contains updated standards regarding electronic records intended to increase clinical trial quality and efficiency.

Sections addressing software and computer system include:

• Section 1 (Glossary) definitions of audit trail, certified copy, validation of computerized systems
• Section 4.9 (Records and Reports) requirements for audit trails for source data, source documents, trial records, and CRF changes
• Section 5.0.2 (Risk Identification) inclusion of risks associated with computer systems
• Section 5.5 (Trial Management, Data Handling, and Record Keeping) detailed requirements for system validation, user training, audit trails, security, backups, blinding, upgrades and migrations, as well as SOPs for system validation, installation, maintenance, security, change control, backup/recovery, contingency planning, decommissioning, and data management
• Section 8 (Essential Documents) requirement for easy retrieval of essential documents by both the sponsor and the investigator, whether paper or electronic