ICH E6 Revision 2 – What Does It Mean In Practical Terms?

Nowadays we all use multiple electronic systems in clinical trials. Consequently, we need SOPs in place to define/control how these are developed, used, accessed and secured to ensure [the regulators] of the integrity of the data we produce.


We’ve been doing corrective and preventive actions (CAPA) for years but Revision 2 emphasizes the need to analyse the “root-cause” before we implement CAPA so that this will be more effective.


We’re introduced to the need for “Quality Management” in conducting clinical trials and this can be summarized as:

  • Be clear on what [clinical trial] you are trying to do
  • Define what is critical to success – data & processes
  • Identify the risks – “What could go wrong?”
  • Evaluate these – “How likely? / What impact? / How will we know?”
  • Control them – “What will we do and at what point?” [Triggers]
  • Communicate – “Does everyone understand our methodology and plans?”
  • Review – “Are our plans working? / Are the right risks being managed?”
  • Report – “Tell the story of the clinical trial”:
    • What happened?
    • What did you do about it and when?
    • What impact did it have? (i.e. Does it matter?)
    • Why should the regulators consider your data reliable?


Sponsors are encouraged to be able to explain how they ensured that their vendors did the correct thing in completing tasks on their behalf [Oversight].


To find out more about how TRI are helping companies take a simple and pragmatic approach to compliance with the new ICH revision 2 guidelines, please just click on the link below to contact us: