02/02/2021
Photo by Bill Oxford on Unsplash
Our article “An ISO 14155:2020 Primer — Good Clinical Practice for Medical Device Trials” was recently published in the Clinical Leader HERE. Following is some background.
The International Organization for Standardization (ISO) is composed of a network of national standard bodies that do not describe country-specific requirements and is the world’s largest developer of voluntary standards. Its goal is for the applicable industries to be more efficient and effective. International standards give specifications for products, services, and good practice. ISO standards help ensure global consistency in a variety of areas and industries, including clinical trials. Although the standards are voluntary, some regulatory authorities or companies require an ISO standard to be followed. If an ISO standard is listed in the protocol as a requirement, documented training and compliance on the standard is needed, not just on the protocol. In these instances, the ISO standard would be enforceable. In the United States, ISO standards are not required by the regulatory authorities, but it may be enforceable at the protocol level. US regulatory authorities want evidence of training and compliance where applicable. ISO 14155:2020, Clinical investigation of medical devices for human subjects — Good clinical practice, is a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.
Designing and conducting a clinical trial should be done with Good Clinical Practice (GCP) and quality in mind to ensure the reliability of trial results as well as to follow requirements of regulatory authorities. Organizations usually understand the necessity of following ICH E6(R2) to ensure GCP; however, there is frequently a gap in training internal teams, contractors, CROs, and sites on ISO 14155:2020 GCP for medical devices. Following the standard is a key part of building globally recognized GCP into the full lifecycle of the medical device clinical trial and can complement the current GCP training.
Read the full article “An ISO 14155:2020 Primer — Good Clinical Practice for Medical Device Trials” HERE.
Concerned your organization has a training gap related to medical device GCP? Clinical Pathways offers an overview of ISO 14155:2020 eLearning available for individual course purchase (HERE), off-the-shelf eLearning in our LMS, full SCORM package delivery compatible with your LMS, or fully customizable to your branding in ours or your LMS. We can develop an entire curriculum to meet your organization’s training needs, whether it is related to medical device or another focus. Email us at info@clinicalpathwaysresearch.com for more information.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.