Within the first a part of this sequence, I highlighted three frequent errors in protocol design that make scientific trials extra complicated than they have to be — particularly for the folks tasked with executing them. In case you missed it, you possibly can catch up right here: Keep away from These 3 Protocol Pitfalls in Medical Analysis.
Since publishing that submit, I’ve heard from dozens of CRCs, PMs, and different analysis execs who provided further examples (and some battle scars) of navigating protocol complexity. The themes have been clear: the challenges are systemic and so they’re costing us time, cash, and good science.
So, let’s proceed this dialog. Listed here are three extra protocol errors that deserve a highlight.
Mistake 4: The “Select Your Personal Journey” Eligibility Standards
Some protocols are written like thriller novels. You begin studying an inclusion criterion, then soar to an exclusion be aware, which leads you to a footnote, which refers to an appendix. By the point you’ve assembled the total eligibility puzzle, the screening window is over — or worse, a affected person was enrolled incorrectly. Queue your favourite protocol deviation soundtrack.
Clear eligibility standards aren’t only a nice-to-have — they’re important for decreasing costly display failures and avoiding protocol deviations. When standards are scattered, lacking, ambiguous, or contradictory, websites are compelled to interpret, guess, or delay enrollment. Every of these paths wastes time and will increase danger for website and sufferers alike.
What’s attention-grabbing is that initially look, what would possibly appear to be a recruitment difficulty is definitely a extra sophisticated screening, enrollment, and conduct difficulty. Websites will deprioritize your protocol if it’s extra complicated than others enrolling at their website.
Mistake 5: Obscure Timing Home windows
There’s an enormous distinction between “Day 1” and “inside 7 days of Day 1.” And but, protocols typically toss round these phrases with out sufficient context or consistency. This creates confusion round go to home windows, lab timing, dose administration, and extra.
A coordinator shouldn’t have to construct a Gantt chart to schedule a affected person go to. Precision in protocol language issues. Each go to and process ought to have a clearly outlined window — and if flexibility is allowed, it ought to be explicitly said with examples, not buried within the third-degree footnote.
I’ll share an instance I noticed first-hand just lately. Screening actions could possibly be accomplished as late as 10 pm on the day of screening, however due to lab work processing instances, Day 2 ought to have been 24 hours after Day 1 actions accomplished— however that wasn’t famous explicitly within the protocol. This created an unlimited quantity of guesswork and 22 pointless emails among the many complete examine staff.
This lack of readability and examples introduces unnecessary danger that might jeopardize the science and, extra importantly, the protection of the affected person.
Mistake 6: Layered Protocol and Supporting Doc Variations That Don’t Discuss to Every Different
Let’s say you’re working with model 6.0 of a protocol. You assume the SOA displays that model…however the lab guide? That’s nonetheless referencing model 5.2. The ICF was up to date, however solely in model 5.9. Immediately, you’re working three timelines, ending up in lifeless ends and creating an internet of references amongst your examine paperwork.
That is greater than an annoyance. Layered, non-synced variations create actual deviation danger. One CRC advised me she didn’t know a process had been eliminated in an modification as a result of the positioning coaching hadn’t caught up. The end result? A totally pointless process and an sad affected person.
It’s 2025. Vehicles self-drive and TVs now double as image frames, but the scientific trial trade nonetheless struggles with model management. But it surely doesn’t must be that means. Instruments like ProofPilot’s Website Hub make it straightforward to centralize and handle all examine paperwork, with model management, replace notifications, and clever search functionality. Moreover, Go to Overviews may be up to date quickly to make sure detailed workflows are all the time correct.
Protocols are our playbook. But when the playbook retains altering, contradicts itself, or buries the foundations, even the perfect gamers are set as much as fail. CRCs, examine nurses, investigators — all of them deserve higher.
We do not want good protocols. However we do want cleaner, less complicated, and better-connected ones. As a result of the price of getting it mistaken isn’t only a busted workflow — it’s a delay in getting efficient remedies to sufferers who want them, introducing monumental monetary danger, and needlessly risking affected person security.
Let’s do higher. (And sure, Half 3 might be coming.)
