(Word count: 411)
Organizations preparing for inspections fall into two distinct camps: gatherers and trackers.
Gatherers pull useful documents from the Trial Master File (TMF) and reorganize them on a more user-friendly shared repository for ready retrieval. This is fairly common practice, and not just at inspection time. If you’re currently working on a clinical study, it’s a safe bet that you have a folder on your hard drive called “Protocols” with each protocol and amendment in it. No matter that the TMF has the same folder; the very act of gathering and organizing those documents is an aide memoire, and the knowledge that you control your access to them is a true comfort.
Gathering is an instinct as old as time; it’s like stockpiling toilet paper during an emergency. You realize there is a supply chain designed to deliver toilet paper to your local store so you can buy it whenever you need it, but given current events, you’d feel better with a stash in your basement where you’re sure you can get to it.
Just like hoarding toilet paper has an adverse effect on the supply chain, gathering documents outside the TMF can affect the integrity of your document control process. Instead of controlling documents in one secure repository with strict processes to govern changes, you’re now controlling them in two repositories, one secure and one rather insecure. If you’ve ever worked on a team that’s pulled the less-than-final version of a protocol off a poorly-controlled shared drive, amended it, and then realized that it didn’t include all the previous version’s updates, you know first-hand the risks of “gathering.” Now imagine an inspection situation where you have two slightly different versions of the same amendment sitting in two different repositories. It’s hard to defend the integrity of your document control practices when that comes to light.
If your inspection team are gatherers, it can be useful to look at the root cause. Is it because the TMF has gaps? Do some team members lack access? Is the TMF difficult to use? Consider redirecting the effort spent on gathering to addressing underlying TMF issues – it will pay dividends throughout the life of the study.
If your inspection team MUST gather, at least train them to pull documents only from the authorized controlled repository for all regulated activities, such as change control, and while fulfilling inspection requests. Personal document stockpiles are reference copies only.
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.