What are the changes?
Unlike the ICH GCP E6 R2 Guideline that is currently in force, the ICH GCP E6 R3 will not be an integrated addendum; the structure of the document has been totally revised.
This new layout will give the document greater clarity and readability.
In particular, the document will have the following structure: an introduction, a chapter focused on the ICH GCP Principle, two Annexes, a glossary and three appendices.
Annex 1 is dedicated to the management of interventional clinical trials and consists of four sections: IRB/IEC, Investigator, Sponsor and Data Governance-Investigator and Sponsor.
Annex 2 is not yet available.
Below are some changes introduced by the Guideline in terms of content:
- The glossary has been enriched with new terms, many of which are related to the field of Computer System Validation and digitalization (i.e. Computer System Validation, metadata, data acquisition tool);
- Several clarifications have been added regarding the principles;
- The concept of electronic Informed Consent has been introduced;
- The implementation of quality by design and risk mitigation strategies is strongly encouraged;
- Some responsibilities of the Sponsor relating to the following topics have been clarified: monitoring, investigational product, quality management and sponsor oversight;
- The main clarifications regarding the Investigator's responsibilities concern the identification and maintenance of source records, the need to carry out the data review in a timely manner and the delegation of responsibilities to the staff;
- With regard to essential records, the guideline distinguishes between essential records (applicable for all studies) and potential essential records (to be implemented based on the characteristics of the study);
- The most significant change concerns the introduction of the concept of data governance which applies to both Sponsor and Investigator.
What is data governance?
This new paragraph offers guidance both to investigators and sponsors on how to perform an appropriate management of data integrity, traceability and security.
How can PQE support customers in complying with ICH GCP E6 R3?
PQE can support customers in carrying out an impact assessment of the Guidance on their processes and in implementing the most suitable solutions for their needs
