Continuous records quality: building quality checks into daily records operations
Teaches the RC to build quality checks into the daily flow of records operations so that deficiencies are detected and corrected as they occur, not six months later during a monitoring visit.
The finding that should never have survived six months
A monitor arrives at a site managing 12 active studies for a routine monitoring visit. Within the first hour, the monitor opens the regulatory binder for a Phase III oncology trial and discovers that the current IRB approval letter -- the letter documenting the committee's annual continuing review -- is missing. Not misfiled. Not in the wrong section. Missing entirely. The site received the letter six months ago. The principal investigator's administrative staff forwarded it to the clinical research coordinator. The coordinator filed a copy in the study's operational folder. But the regulatory binder -- the binder the monitor reviews, the binder that would be examined during an FDA inspection -- never received its copy.