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 jobs efficiently.
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 as a quality control to ensure oversight of their studies, but is not specific about how this should be accomplished. One existing model is for the sponsor to send either staff or contracted Clinical Research Associates (CRA) to the investigational sites to review patient medical records, study specific records, and compliance with the regulations. Historically, these CRAs verified 100% of the data collected for each patient against the medical record. It is called 100% Source Data Verification (SDV) when every data field is verified against the medical record, or source document.
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 a regional CRA, or a Clinical Site Coordinator enrolling patients, here are three easy tips from the team at Hart Clinical team to help you stay healthy this summer.
- Take a water bottle with you. Staying hydrated is one of the most important things you can do this summer. According to the American Heart Association, staying hydrated is critical for your heart health. When you stay hydrated, your muscles, including your heart, don’t have to work as hard.
Clinical trials are complex and costly. With 2010 estimates of average total expenditures for a pivotal clinical trial in excess of $40 million for a PMA product and nearly $11 million for a 510(k) product, sponsors understand the value of executing an efficient, high quality trial.
With the ever-increasing costs associated with conducting clinical trials, many medical device and pharma companies continue outsourcing various operational pieces to contract research organizations (CROs) and other augmentation service groups. By doing so, they are often saving money and the trials are typically completed faster (up to 30%) than when kept in-house (American Pharmaceutical Review ).