The U.S. Department of Health and Human Services (hereinafter HHS), as well as fifteen other Federal Departments, have announced proposed revisions to their policies for the protection of human research participants, known as the “Common Rule”. The 131-page document (also referred to as “NPRM”) can be found here and the public was invited to comment before […]
Category Archives: Regulatory Affairs
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Guest Blogger Andrew Milroy – HRPP and CQA Manager (Merita CQA) For 19 years ICH GCP E6 has not changed. Now, nearly two decades after its initial release, change is coming. Perhaps the biggest difference is the focus and preeminence of Quality Management. A modernized quality standard for clinical study processes is being espoused which […]