IRT Commandment #2
Thou Shall Not Defer Functionality
This one might start a fight
I recognize my opposition to this practice is a bit controversial in the IRT space. This is primarily true because it is common practice and promoted by both sponsors and vendors.
When timelines are short and teams are focused on the “go live date”, they often choose to defer limited IRT functionality to a future 2nd or even 3rd release to reach first patient in (FPI) deadline. My experience has repeatedly demonstrated that this approach leads to
· Inefficiencies
· compromised quality
· regulatory misalignment
I have been the victim of a deferred functionality quality failure. The cause of the failure was directly attributed to the functionality being designed and implemented after the initial “go live”. When the change was deployed the context of this feature within the broader system and its downstream impacts were not fully understood. This is even more likely to happen when “Change Control” development resources are brought in rather than the original development team.
In a past life, my organization had a finding by a regulatory authority because we put a system live that was not 100% in alignment with the protocol as written, having chosen to defer functionality that was not immediately needed. I was surprised by the finding but the discussion with the inspector helped me see the light. The expectation was that even a protocol with a long open label run-in period must deploy unblinding in the initial go live if there is a future blinded part of the regimen.
I wish every IRT provider and sponsor would run this simple exercise; Review your IRT go live date with the date of first action or first site activated. The notion that IRT is the rate limiting factor for studies to go live is simply nonsense. I won’t tell you how long it was when I reviewed data from my organization but let’s just say it was looooong. You’re trying to solve for a problem that is unlikely to be a real problem while creating a whole host of others that can absolutely sink your study.
I know this is hard. Particularly when every voice in your ear is saying “this is the most important study in the company”. If this is true, then treat it that way with the highest degree of quality and not just speed.
Up Next Commandment #3- Thou Shall Not Conflate Visit Date & Transaction Date