Something to Dump This Valentine’s Day
A breakup can be painful—especially around Valentine’s Day. Unfortunately, it happens enough that February 13th has gained the unofficial moniker of National Breakup Day. The day got that nickname when a study commissioned by Virgin Mobile concluded that 59% of survey respondents would purposefully break up with someone just before Valentine’s Day to save cash on gifts. Ouch.
Sitting across the table from it’s not you, it’s me is an undeniable feature of the human experience. While rejection is something we all must face, it is often followed with a fascinating phenomenon. Once the initial sting fades, time has a habit of rewriting the bad memories of the separation with a hopeful sense of purpose. Why? Because breakups happen for a reason: the relationship ended because it became unhealthy. Goals became unaligned, life circumstances changed, or fundamental incompatibilities emerged. None of these are the building blocks of a happy relationship. With enough time, space, and reflection, we all will conclude that a new start was for the best. It’s the best opportunity we receive to reassess our own goals and shed what preconceived notions were holding us back.
The difficulty—but importance—of letting go of the past brings a popular LinkedIn post by clinical research though-leader Brad Hightower to mind:
No regulation requires CVs to be signed and dated or updated throughout the course of a study.
Just another fun example of self-imposed extra work that is so ubiquitous in our industry.
Hightower is indisputably correct. There is no regulatory basis for signing or updating CVs as part of clinical trial documentation. The intention behind this quirk of clinical research tradition is likely to demonstrate sponsor oversight, as the responsibility of the sponsor to continuously evaluate the qualifications of investigators is clearly outlined in regulation.
Cursory research suggests that the regulatory basis of the CV in clinical research is found in 21 CFR 312.53(c)(2), 21 CFR 812.43(c)(1), and ICH GCP E6(R2) Section 4.1.1. Close readers of these passages will note, however, that according to GCP, it’s entirely up to the sponsor to determine how best to assess an investigator’s qualifications. In fact GCP states that the sponsor, “should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).” One could presumably interpret this quote to mean that other relevant documentation might be used in place of a CV if it can better demonstrate the investigator’s qualifications, although admittedly collection of the CV appears to be a non-negotiable according to CFR.
All of this is to say that there are undoubtedly better ways to demonstrate sponsor oversight of investigator qualifications than by obsessively filing away photocopies of the same CVs. We are now aided by modern processes, improved training, and stunning advances of eClinical technology. So why do CTAs and CRAs spend hours of effort (and boatloads of trial site goodwill) asking for CVs to be signed, resigned, and updated?
You know the answer: Because we’ve always done it that way.
It’s an easy excuse to fall back on in such a highly regulated and risk averse industry. If you take a step back, however, you’ll realize that change is as constant as it is inevitable—even in clinical research. After all, Valentine’s Day is theorized to have begun as a violent Roman celebration “where men sacrificed a goat and a dog, then whipped women with the hides of the animals they had just slain”. Clearly, letting go of the past, no matter how comfortable or sacred, is essential for both a healthy present and a brighter future.
So, this Valentines Day, instead of dumping the unsuspecting beau, ax that TMF process you know just doesn’t make sense anymore. If you’re concerned there will be push back, take the time to build your knowledge and sharpen your proposal through a strong foundation of regulatory understanding. We’d be proud if you used our library of blogs and TMF content to build your case using the latest industry best practices, resources, and regulatory intelligence. If you still can’t win them over, feel free to point out that, in the space of just two millennium, a pagan ritual for sacrificing goats somehow became a day for greeting cards, lace, and chocolate.
Oh, and 1572s don’t expire. FDA even says so.