Author: Dana Fletcher

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Five ways to avoid scope creep in clinical trial execution

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?

What does THAT mean?  Good Clinical Practice glossary series: Serious Adverse Events

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.