Please FDA – Retraining is NOT the Answer!

The FDA has recently issued a draft Q&A Guidance Document on “A Risk-Based Approach to Monitoring of Clinical Investigations”. Definitely worth taking a look. There are 8 questions and answers. Two that caught my eye:

Q2. “Should sponsors monitor only risks that are important and likely to occur?”

The answer mentions that sponsors should also “consider monitoring risks that are less likely to occur but could have a significant impact on the investigation quality.” These are the High Impact, Low Probability events that I talked about in this post. The simple model of calculating risk by multiplying Impact and Probability essentially prioritises a High Impact, Low Probability event the same as a Low Impact, High Probability event. But many experts in risk management think these should not be prioritized equally. High Impact, Low Probability events should be prioritised higher. So I think this is a really interesting answer.

Q7. “How should sponsors follow up on significant issues identified through monitoring, including communication of such issues?”

One part of the answer here has left me aghast. “…some examples of corrective and preventive actions that may be needed include retraining…” I have helped investigate issues in clinical trials so many times, and run root cause analysis training again and again. I always tell people that retraining is not a corrective action. Corrective actions should be based on the root cause(s). See a previous post on this and the confusing terminology. If you think someone needs retraining, ask yourself “why?” Could it be:

      • They were trained but didn’t follow the training. Why? Could it be one or more of the Behavior Engineering Model categories was not supported e.g. they didn’t have time, they didn’t have the right tools, they weren’t provided with regular feedback to tell them how they were doing? Etc. If it’s one of these, then focus on that. Retraining will not be effective.
      • They haven’t ever received training. Why? Maybe they were absent when the rest of the staff was trained and there was no plan to make sure they caught up later. They don’t need retraining – they were never trained. They need training. And is it possible that there might be others in this situation? Who else might have missed training and needs training now? Maybe at other sites too.
      • There was something missing from the training (as looks increasingly likely as one possible root cause in the tragic case of the Boeing 737 Max). Then the training needs to be modified. And it’s not about retraining one person or one site on training they had already received. It’s about training everyone on the revised training. Of course, later on, you might want to try to understand why an important component was missing from the training in the first place.

I firmly believe retraining is never the answer. There must be something deeper going on. If your only action is retraining, then you’ve not got to the root cause. I can accept reminding as an immediate action – but it’s not based on a root cause. It is more about providing feedback and is only going to have a short-term effect. An elephant may never forget but people do.

Got questions or comments? Interested in training options? Contact me.

 

Text: © 2019 DMPI Ltd. All rights reserved.

4 thoughts on “Please FDA – Retraining is NOT the Answer!”

  1. I would say that retraining is an overused CA that usually does not address most root causes related, even to training.
    But I would not go so far as saying it’s never a corrective action.

    For example, retraining might be appropriate for someone who underwent an event during that training that caused a deficiency–for example a toothache, personal issues that may have distracted him or her. Perhaps construction disrupted the training session–or power or network outage.

    1. Thanks Sue. I take the point. Although I might frame it differently. In this case, I think the retraining is a correction (or immediate action). A corrective action would be to add a verification step after training to assess competency i.e. have those being trained learned? If they have not then something must have gone wrong in the training and that should be remedied straight away. Perhaps it’s a case of definitions?

      1. I agree all the way! I generally think that training is a very tricky risk management strategy. Most successful risk management strategies I have witnessed or initiated were based on making the error not possible therefore eliminating the need for training in a particular aspect.

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