10 areas that may impact your organization
The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Designed to better manage risk, patient safety, and data integrity in clinical trials, the updated guideline is expected to be adopted by regulatory authorities worldwide. As such, research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.
While the latest revision marks progress in advancing transparency and scientific rigor, it also demands a thorough reassessment of research practices to ensure adherence to new regulations. Read on to explore how ICH E6 (R3) may affect your ongoing and future trials—and use the following 10 critical categories of questions to assess your readiness. If you find yourself uncertain about any of these areas, now is the time to prepare.
Greater Emphasis on Managing Risk
Although protocols are intended to identify and reduce risks by laying out processes before a trial begins, ICH E6 (R3) introduces specific considerations to improve early-stage clarity and decision-making. These include:
1. Proportionality: Are your protocols designed and implemented in a way that proportionally minimizes patient risk and protects data integrity?
2. Quality by Design (QBD): Are your trials fundamentally incorporating QBD concepts in development?
3. Efficiency: Are you re-evaluating your protocol templates and procedures to ensure risk management, protection of patients, and furthering the primary goals of the current study? Have you eliminated irrelevant legacy sections that do not have direct bearing on your current study?
Patient Communication Becomes a Stronger Focus
Many of the adjustments in R3 center around justifying patient selection and ensuring patients themselves have a clear and accurate understanding of the risks they face. When reviewing your own protocols, consider:
4. Patient selection and public involvement: Have you reviewed your rationale for participant inclusion/exclusion? Are the criteria justified and aligned with study objectives?
5. Patient consent: Do your consent documents meet patients’ language and literacy needs across media formats (text, visuals, video)? i.e. Are they available in the correct language(s)? Are they written to meet patient comprehension levels?
6. Digital Tools: Is your protocol designed for remote care realities, such as remote monitoring, diagnostics, and laboratory logistics? Are you using the right tools to support these needs, such as, eConsent, remote data acquisition tools, mobile apps, telehealth solutions, secure monitoring or auditing solutions?
Providing More Clarity Around GCP and Data Integrity
At its core, Good Clinical Practice (GCP) is about faithfully applying the scientific method to deliver the best data possible, and data integrity is about ensuring that data is accurate and reliable for analysis. GCP standards are already quite robust, so the new revisions in R3 primarily revolve around increasing clarity around roles and responsibilities, ensuring all decisions are clearly documented, and that stakeholders are held accountable as appropriate. You should review your current processes surrounding:
7. Documentation: Do you have robust document storage and distribution processes outlined?
8. Data integrity: Are your current, or planned systems (eTMF, CTMS, CDMS, etc.) aligned with new auditability standards? Are you validating new tools and vendors against these expectations?
9. Roles & Responsibilities: Are key decisions documented with clear rationale, responsible parties, and supporting data? This is especially critical when sponsor partners are involved.
10. Staff training & protocol compliance: Are your protocols and procedures being updated to incorporate these core tenets of R3? Have you trained your staff and partners in these updated protocols and procedures?
Taking the Next Step
Research organizations all over the world are working to adhere to these guidelines before they become regulatory requirements in their respective countries. The good news is that there are experts experienced in ICH E6 guidelines who can help you identify and navigate changes you may need or want to implement.
Advarra is one of the largest GxP consulting groups in the world and has served clients for over 25 years. Over 1,500 GxP projects are completed annually with Advarra, covering every GxP area across pharma, biotech, and medical device research. With experience in over 75 countries, Advarra can help wherever your study is based. Our auditors speak 32 languages, and each has over a decade of experience in international and local regulatory requirements. With Advarra, you can trust an experienced, dedicated team that brings global experience and a commitment to excellence to every client engagement.
Partner with Advarra and gain confidence in aligning to the latest ICH E6 guidelines.
