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.
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.