IMARC Research has created a new whitepaper that highlights the Guidance for Ensuring your Clinical Study is Being Designed, Executed, and Monitored in Accordance with the ISO 14155.2011 International Device Standards. The goal of this paper is to introduce some suggestions on how to set up a study for successful compliance with both the FDA regulations and ISO 14155, giving some practical advice on how these additional ISO requirements can be added.
An increasing trend in the clinical device research industry is the inclusion of the International Organization for Standardization 14155:2011 (ISO 14155) guidelines into research protocols. IMARC previously published a whitepaper, which provided readers with a detailed comparison between the FDA regulations for clinical studies and the ISO 14155 standards. This whitepaper focuses on clinical investigator compliance with both the required FDA regulations and ISO 14155, specifically on where these guidelines overlap and what additional steps are necessary to comply with ISO 14155.
The Sponsor’s goal may be to utilize international clinical data for a trial run in the U.S. Or perhaps the Sponsor plans to only use sites outside of the U.S. for their study. In either case, incorporating the guidelines from ISO 14155 in addition to any other required regulations can only increase the quality of the subsequent trial data, barring that measures to ensure compliance with ISO 14155 are clearly outlined from the start.
Please take time to download IMARC’s new whitepaper and share your thoughts on this important topic with us.