Key “Critical to Quality” Factors in newly released ICH E8(R1) Guidance for Designing Quality into Your Clinical Trial – SterlingBio Smart CRO Services and Solutions

Key “Critical to Quality” Factors in newly released ICH E8(R1) Guidance for Designing Quality into Your Clinical Trial

QMS Clinical Trials

Clinical trials are incredibly important for bringing safe and effective treatments to market to help patients who need them.  With that in mind, the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use just released the final adopted ICH Harmonised Guidelines of General Considerations for Clinical Trials release E8(R1).  It is the first revision of the E8 document which was originally released in 1997. The release focuses on the internationally accepted principles and practices in the design and conduct of clinical trials as well as guidance to building quality into clinical studies.  It is a crucial time for these guidelines given that many clinical trials today are managed and monitored remotely.

The first 7 considerations in identifying Critical to Quality Factors


  1. Engagement of all relevant stakeholders, including patients, is considered during study planning and design.
  2. The prerequisite non-clinical studies, and where applicable, clinical studies, are complete and adequate to support the study being designed.
  3. The study objectives address relevant scientific questions appropriate for a given study’s role in the development programme, taking into account the accumulated knowledge about the product.
  4. The clinical study design supports a meaningful comparison of the effects of the drug when compared to the chosen control group.
  5. Adequate measures are used to protect participants’ rights, safety, and welfare (informed consent process, Institutional Review Board/Ethics Committee review, investigator and clinical study site training, pseudonymisation).
  6. Information provided to the study participants should be clear and understandable.
  7. Competencies and training required for the study by sponsor and investigator staff, relevant to their role, should be identified.

Check out the full list of Critical to Quality factors listed here

The last consideration in the list of 18 items is, “The reporting of the study results is planned, comprehensive, accurate, timely, and publicly accessible.”  This highlights the importance of tracking all the data, presenting the findings and analytics accurately and in a timely manner, and using automation to reduce mistakes.   

Consider an Open, Connected eClinical System

Set up your eClinical team for success and check out SureClinical’s Eclinical Ecosystem solution.  It includes a suite of connected clinical apps and a collaborative platform where your team can have a singular view of your study.  You can also connect data from other sources to get the full picture, including bringing in data from EDC software apps, as well as other third party applications.  This gives CROs and Sponsors the freedom to choose the apps they would like to use in their study while enjoying a singular view of the information they need.  As a result, all of the data is in one repository and can be viewed and reported upon easily.  Learn more here.