The GCP Compliance Photo Album
I have been asked to provide ‘inspection readiness’ training many times. And while it’s tempting to do it with just one slide, more detailed content such as understanding the inspection process, practical tips about what to do and what not to do, and some insights into what I call the ‘auditor brain’ can help those who may be involved in inspections feel more confident (but not too confident), including both experienced and inexperienced staff at clinical investigator study sites, CROs, sponsors, central labs, and IRBs.
Here’s a metaphor I use in preparing for the inspection experience:
An inspection should proceed like showing a stranger your family photo albums. He or she should just be able to turn the pages, maybe ask a few clarifying questions, learn quite a bit about you (your past, your activities, what matters to you most) and then just thank you for the visit and leave.
Somewhat like the modern craft of ‘journaling’ along with photos to create comprehensive scrapbooks which serve to document when, where, why the photo was taken and who is in it (because years later, who can remember any of that?), your policies and procedures prompt your memory about your organization’s activities and clearly explain to regulatory authorities how your data (aka, the ‘photos’) were produced.
This is especially critical because inspections do not always occur in timely proximity to when the trial was conducted and because staff changes over time. Why risk having to explain a ‘photo’ that you know nothing about – who is in it, where it was taken, why it is even in the album? – particularly when it comes to the core of GCP which is subject safety and data integrity?
There are many more ways this metaphor can be extended – knowing what kind of camera was used and how the images were or can be produced (digital, on film prints, in the cloud) is an integral part of preparing for the process of scrapbooking just like knowing how the EDC software is designed and how it can or cannot capture data is critical to successfully conducting a clinical trial – but, well, um, you get the picture?
Oh, and what would the one-slide version of inspection readiness training be?
● Comply with the regulations
● Do it right the first time, every time
● Documentation, documentation, documentation
Simple but not easy.
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