This is the third in a series of entries on travel tips for clinical operations personnel. We’ve looked at airport pre-check and administrative tools, and today we are going to talk about some of our CRA’s favorite internet resources for traveling.
Ah, the dog days of summer—vacations are coming to an end, kids are getting ready to go back to school. It’s time to get serious!
You’ve heard the story before. FDA has approved the protocol. The sponsor has contracted with a Clinical Research Organization (CRO) to initiate and manage their clinical trial sites and electronic data capture database. They’ve done everything in their Clinical Standard Operating Procedures to start their new trial. Then they start seeing delays with IRB approvals and enrollment. They start having to increase the time spent
Our last post in this series on the 62 Good Clinical Practice (GCP) glossary terms described three of the four categories of side effects in a clinical investigation: adverse events (AEs), unanticipated AEs, and adverse device/drug effects. The last category of side effects in the glossary for us to explain here is the term, serious adverse events, or SAEs.
The glossary of the ICH GCP guidance lists 62 entries, which originally applied to clinical trials of drugs and biologics, but has since been applied to clinical trial data for medical devices as well.
Not so many years ago, if you posed this question to an experienced Clinical Operations Professional, you may have gotten responses like: lots of Post-It notes! Or: a miniature stapler! In today’s healthcare world, where paper remains a staple, but EMR and global connectivity increasingly digitizes our work, these tools are not enough. Today’s CRA relies upon both physical and electronic tools to do their
First, some monitoring basics…
Sponsors of human clinical trials that evaluate new drugs, biologics, and medical devices are responsible for maintaining a high standard of quality and ethics. This means that they must ensure that study participants’ rights, welfare, and safety are protected, and that accurate data are collected, analyzed, and reported to the U.S. Food and Drug Administration (FDA). FDA requires that sponsors use monitoring
This series will review and elaborate on the glossary terms listed in the Good Clinical Practice (GCP) Guidance adopted by the United States Food and Drug Administration (US FDA) for conducting clinical trials.
Today’s blog is entry #1 addressing tips and tricks for efficient travel – we like to call it:
This is our first entry in the “Hart’s Voyagers” blog series dedicated to the traveling CRA looking for some simple ways to stay on top of their daily health and well-being.
As busy clinical affairs professionals ourselves, we understand how difficult it can be to stay healthy in the fast-paced, demanding world of clinical trial operations. Whether you are a Director of Clinical Affairs, on the road as