Simulations Plus Has Acquired Pro-ficiency!

Stop the SIV Madness

At the outset of this post, I want to make one thing clear. I am a huge fan of and an advocate for CRAs.  I’ve been one and I have spent the better part of my career mentoring, teaching and helping CRAs develop their competency to effectively monitor clinical trials to ensure protocol and GCP compliance.  So it is not for a lack of respect for all the great CRAs and monitors out there that I am proposing we STOP THE MADNESS of having CRAs conduct site training at site initiation visits (SIVs).  Seriously.   Think about it.

You go through a rigorous process to select investigators qualified by training and experience (ICH 5.6.1).  You’ve secured their willingness to comply with the protocol (ICH 5.6.3).  You cover your regulatory requirements to provide them with the information they need to conduct the trial (5.6.2) (even though the guidelines ICH GCPs don’t actually mandate that the sponsor is responsible for training the site).  And, you create the ideal training materials and methods and validate that the sites are competent, qualified and trained to conduct the trial (see Parts 1 and 2 of this blog post series).  But you have absolutely no faith that your site qualification and training processes work so you send the CRA out to further “train” the sites at the SIV.  What are you hoping to accomplish by doing this other than potentially annoying and alienating your site?  Even worse, potentially undermining the effectiveness of the training the sites have already completed by having CRAs who are not necessarily skilled trainers (nor presenters of content) take the site through a death-by-slides march.

I encourage you to pause right now and count the # of slides you have in your SIV training deck.  My running average, having viewed hundreds of these in my career, is 212 slides. No joke.

So imagine wanting to be the sponsor or CRO of choice.  Now imagine you are a busy investigator (who has already completed your training) being lectured to by a CRA who drones on for hours reading slides that regurgitate word for word, the information in the protocol that the PI has already read, signed and agreed to comply with!  Not to mention that the CRA, who may be new (in general, or to the study) or who is managing multiple studies, has had little time to review the slides in advance.  Or that the CRA received no special training on the study, other than the slide deck.  Or that the training doesn’t include any practical examples, case study materials, simulation exercises or job aids.  Or that the CRA has never received training in how to be an effective trainer.  Any wonder that all the PI (and site staff) want to do is leave the room as quickly as possible to avoid this painful process?!?

Not only have you just undone any value from what was hopefully an effective training approach to begin with, but you have literally disengaged your site staff from wanting to work on your protocol.   You’ve set the site and the CRA up for failure, to what end?

I believe that your site training approach is not only critical to preventing deviations, but should be viewed as a site engagement strategy.  The more relevant, impactful, and dare I say, enjoyable the site training experience is, the more your sites will be interested and eager to work on your study.  Plain and simple.  By eliminating the pressure on the CRAs to attempt to “train” the sites in this fashion, they can focus on what they do best, which is developing productive site relationships and monitoring the study.  The SIV can therefore focus on what really matters to the success of the study:

  • Ensuring the site is operationally ready to implement the study
  • Checking that all equipment is received and in working order
  • Verifying that supplies are adequate
  • Guaranteeing the site has a proactive recruitment action plan in place and is truly enrollment ready the moment the CRA walks out the door.

Not convinced?   Then try this thought experiment.   What’s the worst possible outcome you could have if you eliminate the “training” aspect from your SIV?  What’s the best possible outcome…for your sites, your CRAs, and your study?   I challenge you to “stop the madness” and see what actually happens to your enrollment and deviation rates. I guarantee you’ll be happy with the results!

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