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Inspection Readiness Strategies to Combat Turnover

Even before the Great Resignation, the pharma, biotech, and medical device industries struggled with turnover.  Where a shortage of trained people meets a wealth of opportunities–particularly in small companies where promotions from within are rare, but a “title bump” is always negotiable for an incoming resource–turnover is rampant. Estimates range from 13% annually across the industry to a whopping 25% for site monitors.  When you’re preparing for an inspection, though, even a single departure can be devastating.  A large proportion of inspection questions refer to start-up activities.  When the person who designed the protocol or selected the vendors or wrote the specifications walks out the door, a lot of valuable knowledge walks with them.

Smart sponsors and vendors anticipate turnover and put plans in place to ensure continuity of the “quality story” in spite of it.  Some key strategies:

TMF location map.  Record locations of documents that are not in the primary Trial Master File repository.  In many companies, contracts, clinical supply records, regulatory submission documents and correspondence, safety records, datasets, and statistical deliverables are filed in function-specific repositories. This general good practice (and GCP requirement!) avoids institutional memory loss caused by staff departures.

Handover process.  Most Contract Research Organizations have a formal process to document transitions from one staff member to another, but many sponsors don’t. It’s worth the time to develop to ensure that outgoing staff trains incoming staff on plans and current status of the study. This process produces the documentation needed to prove that the new person was appropriately trained, but even more importantly, it ensures that key information doesn’t fall through the cracks.  (Once upon a time I worked with a sponsor that grew dissatisfied with a vendor and decided to cut them loose.  They went through a lengthy evaluation process to find a new vendor, auditing two candidates so they could make an informed selection, and selected one.  Then several key people left in succession, and the new vendor was never onboarded.  Several years down the road, the existing vendor, having no idea that they had been fired, made several costly mistakes.  Transitions are important!)

Team list. It’s important to update team lists with departures and arrivals and to file regular updates in the Trial Master File, where team members can find them and regularly QC them. Many sponsors and CROs compile and file this list at the end of the study, when details may have been lost. Assign responsibility for quarterly or even monthly updates.

Vendor list. Most companies have an approved vendor list, but it doesn’t always identify vendors by study, and it typically does not include subcontractors.  Study-specific vendors lists can be found in vendor oversight plans, contact lists, project plan, data management plans, monitoring plans – but all too often, they are incomplete.  A single definitive study-specific list will help ensure that no vendors are “forgotten” before inspection.

CVs. Many organizations are moving to maintaining CVs only in HR files, rather than re-filing them in the Trial Master File. Although double-filing is typically not typically recommended, in this case, it is helpful to have CVs under the study team’s control. In the TMF, CVs can be easily cross-checked against team lists, training records, and job descriptions. Team members are not typically permitted to access HR files, so deficiencies in CVs that “live” in HR may not come to light until they are requested during an inspection.

Storyboards. Storyboards that summarize the “quality story” of a program are a terrific hedge against turnover. Although storyboards are inspection readiness tools, they need to be developed before critical resources leave, which may be months or years before the team starts to think about inspection readiness. Storyboards capture the nuances of issues that might be difficult to piece together from TMF documents. We recommend that teams start developing storyboards at the beginning of their registrational study and make it a habit to develop them quarterly. At this stage, any problem, unusual situation, or complex issue should be captured in a storyboard.

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