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 […]
Tag Archives: ICH-CGP
16
Dec
Dec
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 […]
31
Oct
Oct
The desire to contribute to our current understanding of drugs, disease and the human body is very noble. Along with this desire must be a commitment to become qualified to conduct clinical research properly. You can’t learn on the job When I began managing clinical research studies 25 years ago, a Clinical Investigator was a […]
07
May
May
Clinical research is an increasingly complex enterprise, which requires knowledge and skills that are outside the traditional training of physicians and other healthcare professionals. The investigator must, for instance, understand what are the responsibilities of screening research participants, obtaining free and informed consent and supervising a trial. Although it is primarily the sponsor or CRO’s […]