Ensuring Drug Accountability In Clinical Trials

By Sarah Beale, MasterControl

Drug accountability in clinical trials is pretty much what you’d expect. It holds the organizations and people involved in the trial accountable for how they handled the drug being used. Improper drug accountability places the entire clinical trial at risk. Pharmaceutical companies, and regulators, can’t be assured the results of the trial are accurate if there’s information missing from the drug accountability record. This is a critical part of the requirement from 21 CFR Part 312 to maintain adequate records of the disposition of the drug. In some cases, this comes down to simple math. If your records show you provided a subject with 40 pills and he or she somehow took 42, that’s an issue. That might be simple math but ensuring proper drug accountability is far from simple. It requires forethought and consistency to be done properly.