In our last post on the ALCOA+ principle of consistency, we discussed our obligation to compare each source of information for consistency, because an error in one source invalidates all sources. Ideally, we limit redundant sources of information, so we have fewer opportunities to introduce errors.  When we design drug accountability processes and tools we need to pay special attention to the number of sources of information and the elements recorded on each source, so we can develop a process that will provide full accountability. In any given clinical study, drug shipment information may be captured in the following sources:

• IRT/RTSM system reports
• Depot manifests
• Paper packing lists retained by the depot
• Paper packing lists retained by the site
• Site-level drug accountability log
• Site drug accountability system

Dispensation, usage, and return (from subject to site) information may be captured in the following sources:

• IRT/RTSM system reports
• Site-level drug accountability log
• Site drug accountability system
• Subject-level drug accountability log
• Subject-level source accountability log
• Subject diary
• Subject chart

Returns from site to depot may be captured in the following sources:

• IRT/RTSM system reports
• Site-level drug accountability log
• Site drug accountability system
• Site return log
• Depot return log

The first thing we do when performing drug accountability is to make a list of all the different sources of information and give each a color code, like this: Next, we need to determine which information is included on each source. For example, on one memorable study, a kit, identified with a kit number, was shipped with two auto-injectors, each identified by a unique number. The site-level accountability log captured the kit numbers, but the subject-level log captured only the auto-injector identifiers, so a third source - a report from the manufacturer - had to be used to tie the two together.