The Guideline for Good Clinical Practice (GCP) E6(R1) has been undergoing revision since Jun-15 and the revised guidance, the Integrated addendum E6(R2) (‘the addendum’) is planned for finalization soon.

While the addendum includes few additions to investigator responsibilities, the majority of the revisions are related to the sponsor’s responsibilities, particularly to the sponsor’s quality management systems (QMS) and monitoring.

New section 5.0, Quality Management has been included and consequently the sponsor/CRO companies conducting clinical trials will need to ensure that their QMS supports the requirements of identifying, evaluating, controlling and communicating risks to the critical processes and the data:


Section 5.18.3 includes a significant addendum to the extent and nature of monitoring. The sponsor/CROs conducting clinical trials will need to ensure that their standard operating procedures (SOPs) on monitoring supports a risk based approach.

pic-2Furthermore, section 5.5.3 now includes the guidance that the sponsor/CROs handling or capturing electronic data for clinical trials will need to ensure that their SOPs for electronic data processing and reporting systems includes provision for:

  • Computer system validation (CSV)
  • Functionality testing
  • Data collection and handling
  • System maintenance
  • System security measures
  • Change control
  • Data back-up and recovery
  • Contingency planning
  • Decommissioning
  • Training on the use of the computerised systems

Last but not the least, section 5.20 Noncompliance requires that the sponsor/CROs will need to ensure that their auditing SOPs include provision for:

  • Conducting root cause analysis
  • Development and implementation of corrective and preventive actions (CAPA)
  • Reporting serious breaches to the regulatory authorities


Sponsor/CRO companies should conduct a gap analysis of their current systems and procedures and implement adequate CAPA to ensure compliance to the ICH GCP E6(R2) Addendum

If you would like us to conduct a gap analysis for you contact

The ADAMAS Corporate Brochure 2016


Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

Regulatory Environment


The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.



ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.


How to be a Clinical Auditor


‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

Benchmarking Data


Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

Is your QMS compliant?


Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

ICH (E6) R2 Addendum - Step 4


Please enter your details to complete the download.