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Four Steps to Creating a Roadmap to ICH E6 R2 Compliance

Since the release of ICH E6 R2 in November 2016, we have been flooded with opportunities to attend and view webinars, seminars and blogs on the topic. While extremely educational, these industry-led learning sessions rarely provide sponsors or CROs with what you so desperately need… a practical guide to creating a roadmap to compliance. While Regulatory Affairs (RA) and Quality Assurance (QA) departments have likely read these new guidelines, holistic organizational education and awareness of their impact and how they affect the way in which we execute trials are still lacking. Many teams find themselves in a state of inertia and don't know how to jumpstart themselves and their organizations into moving towards compliance. Based on my experience helping organizations to interpret and comply with these revisions, I have a few suggested steps to kick start your compliance journey:

  1. Perform an ICH E6 R2 GAP analysis.
    Whether your organization undertakes this activity or you hire an experienced third-party consultant, a comprehensive review of your global SOPs against the revised guidelines is a great place to start to understand your current regulatory risk. Since these guidelines are in their final state, all companies working under protocol statements indicating they are following the latest ICH guidelines are at risk if they haven't actually re-aligned their processes to these revisions. This review will identify not only gaps at the individual, SOP level but also overall systematic changes that need to occur for organizational compliance.

  2. Identify a set of recommendations and/or agreements to best close the GAPs.
    It's one thing to identify that you have a compliance GAP, but then, you need to take the next step to lessen the risk for your organization that exists with lack of compliance to the guidelines. You need to understand and identify how to close those gaps at the individual and systematic levels. For example, should you revamp your entire root cause analysis and CAPA approach to be risk-based and focused on the issues that matter, or do you just need to update an individual SOP to align to this approach that exists already? These recommendations will help the organization move towards an action plan for GAP closure.

  3. Create an action plan.
    After reaching an understanding of the required actions to close the GAPs, you should determine your overall approach to implementing the recommendations or agreements for GAP closure. The presence of an action plan provides you a certain level of risk coverage should you be audited before you have been able to complete the action plan. Then, at a minimum, you can show the inspector that you have assessed the guidelines, identified gaps and are working towards closing them. This shows a good-faith effort toward compliance.

  4. Project plan it out!
    An action plan is great, but taking it down a step and creating a project plan will help keep everyone in the organization on track for timely completion of their tasks. A word of advice: make sure that you stay honest to the project plan. If that is not possible, it might be best to update it. You don't want to find yourself in a position of showing an inspector all the great work you have completed in moving towards compliance and then present a project plan on which you are woefully behind.

While complying with the revisions to the ICH E6 can seem daunting, taking these few key steps will help your organization start your journey towards compliance. If you are interested in learning more about Bioclinica's standardized ICH GAP/Recommendation Analysis Offering supported by a well-known industry expert on ICH compliance, please contact me directly at


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