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.
With the percentage of the population of the United States over age 50 growing steadily, it is likely that you or someone close to you has attained that status!
Think of a situation where you were trying to connect with a decision-maker. Maybe you were a project manager for a sponsor company trying to recruit investigational sites for your pivotal clinical trial. Perhaps, you worked for a Contract Research Organization (CRO) and were working on a proposal for a sponsor.
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 on site visits because some sites are having problems and need additional training. Because of the delays, management decides to add more sites, which may include a protocol amendment. The original deadline for study completion blows by and the budget explodes. What happened?
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.