Essential documents Deep Dive: informed consent tracking Hart’s Good Clinical Practice glossary series
Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure and clinical protocol/protocol amendments in this portion of our glossary series.
Image courtesy of fda.com
Informed consent is a broad subject and
Hart Healthy Challenge: A tradition of caring.
Heart disease has been the leading cause of death in the US and worldwide for several decades. In the past few years, the burden has slightly decreased, but it remains a health problem that policy makers, providers, and patients are working to prevent.
Luckily, it is also one of the most preventable diseases. To improve awareness and education about heart
Medical Ethics: The Belmont Report
This is the third in a series of articles about medical ethics. Our previous posts in this series included covering the basics of medical ethics and the difference between utilitarianism and deontology. Today we’ll talk about the Belmont Report and its importance in establishing modern medical ethics guidelines.
In our next post in this series, we’ll continue to explore the foundations of
What does it mean to have transferable skills and why does it matter for a Clinical Research Associate (CRA)? We will explore these questions in our post today.
The Cambridge English Dictionary defines transferable skills as “skills used in one job or career that can also be used in another”. Google quickly provides several lists of examples of transferable skills. For example, here, here, and here.
Hart Health Hints:
January is National Blood Donor Month
Did you know that every two seconds someone in the U.S. needs blood? Or that less than 10% of the population eligible to donate blood does so annually?
Although researchers keep trying, it is still not possible to manufacture artificial blood, making blood donations a necessity to supply patients with lifesaving blood products.
The American Red Cross (ARC), which supplies
Hart’s Good Clinical Practice glossary series
Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents, and we looked specifically at the Investigator brochure in our last glossary post. In today’s post, we will dive a bit deeper into what is required for a clinical study protocol.
The guideline defines a protocol as “a document that describes the objective(s), design, methodology, statistical considerations,
Stan Woolen worked for FDA’s Office of Enforcement in the 1990’s, where he was tasked with a great deal of public speaking shortly after he became the Agency Bioresearch Monitoring (BIMO) Program Coordinator. He had years of experience on the ground with GCP and GLP, but found himself in need of shortcuts for helping him organize the tremendous amount of public speaking in front of
THE FUTURE OF CLINICAL RESEARCH: THE CHANGE IN THE AIR.
Some dread it.
Others create it.
Either way, you know it is inevitable.
The clinical research industry is no exception. Ever since James Lind’s famous scurvy trial in 1747,1 where he demonstrated the affliction could be cured by the consumption of oranges and lemons, the concepts, tenets, and processes of modern clinical research have been evolving. This is no
This is the second in a series of articles about medical ethics. In our last post, we reviewed the basics of medical ethics.
Welcome back to the Hart GCP knowledge series. In our last glossary series post, we reviewed the definition of essential documents found in the Good Clinical Practice (GCP) guidelines. In today’s post, we will dive a bit deeper into the Investigator brochure (IB).