Welcome back! This is the Hart GCP knowledge series where we are reviewing key definitions found in the Good Clinical Practice (GCP) guidelines. In this entry, we are looking at the term Comparator Product.
So …you want to know where the US hotspots for clinical research are.
With an estimated 100,000 CRA jobs in the US, the CRA job market is undoubtedly competitive. We asked our CRAs what skills or practices they employ that allow them to stand out as exemplary in this profession.
Clinical trials and clinical studies—What’s the difference? Hart’s Good Clinical Practice glossary series
Welcome to the Hart GCP knowledge series where we are reviewing key definitions found in the Good Clinical Practice (GCP) guidelines. In this entry, we are looking at the terms Clinical Trial and Clinical Study.
The terms tight-knit and close-knit are used to describe a group of people who care about each other and who are very friendly with each other or as a group held tightly together by social or cultural ties. Within the clinical research community, we say it is a “small world” because someone usually knows someone else in another company or at another research institution. People work for years collaborating across the aisles of academia, government, and industry while often moving from one to another, all the while creating close working relationships within the community.
Thankfully, the vast majority of business travel ends without the traveler having to give much thought to car rental insurance, but sometimes accidents do happen. If a deer jumps into your car on a dark highway or someone runs a red light, or any other numerous calamities happen, which can and do happen in a rental car—how do you know you won’t be personally on the hook?
Vendor credentialing began following concerns in the 1990’s after the Health Insurance Portability and Accountability Act (HIPAA) passed in the US in 1996. The law mandated stricter oversight of patient confidentiality.
Welcome back to the Hart GCP knowledge series! We are reviewing key definitions found in the Good Clinical Practice (GCP) guidelines used by regulatory agencies, like FDA, for achieving high quality and consistent clinical trial operations that adhere to the ethical tenets of human research protection.
Have you ever wondered how important it is for your clinical operations staff to have expertise in your therapeutic area? In this entry we’ll hear from some of our in-house experts on their thoughts about this question.