FDA Issues Guidance on ICH Good Clinical Practices
The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design.
Adopted by ICH in 2016, the addendum includes standard operating procedures for electronic trial data system setup, installation and use, and describes system validation and functionality testing and data collection. “The responsibilities of the sponsor, investigator, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use,” according to the FDA guidance prepared under the auspices of the ICH.
The addendum also reflects the proliferation of electronic communications since the initial publication. “Advances in use of electronic data recording and reporting facilitate implementation of other approaches,” the document states. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text.
Other amendments include a recommendation that sponsors document their rationale for choosing on-site or centralized monitoring or a combination of the two. Reports of on-site and/or centralized trial monitoring should be provided to the sponsor with documentation of the results in enough detail to verify compliance with the monitoring plan.