Your Input on ICH Reflection Paper
International Council for Harmonisation (ICH)
ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2).
The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. ICH’s decision to invite stakeholder comment on the proposed renovations at this early stage, ahead of guideline development efforts, recognizes the considerable stake and relevant expertise in the research community beyond ICH. More information on the process is available on the ICH website.
Hamilton Health Sciences (HHS), through input from members of its Executive Committee of Research and the broader research community, will submit comments/feedback in aggregate form. Members of the HHS research community are encouraged to review the Reflection paper on GCP Renovation and forward their feedback to Daniela Bianco by February 21st. Please note that references to source documents that support recommendations/changes are required. These source documents will be appended to the aggregate response HHS prepares and submits.