SOP Training for Clinical Research – Can it be Fun?

sop training

The mere mention of SOP training can make even the veterans among us shudder. But does it really have to be this way?  Does compliance training really differ from any other training?  Shouldn’t we apply the same principles of instructional design?  Does it always have to be the dull, boring, uninteresting, and monotonous “check here that you have read and understood the document” SOP training we all go through?  I think not.

SOP training can be effective, fun, and to-the-point. It can even serve to improve performance among the various roles within your organization.

Before embarking on improving SOP training, it is important to ensure SOPs are just that, SOPs.  Too often companies make the mistake of creating very detailed SOPs that essentially are work instructions.  While the topic is outside the scope of this blog post, suffice it to say that highly detailed procedures warrant their own set of instructional strategies, no matter what you call them.

SOP training can be effective, fun, and to-the-point. It can even serve to improve performance among the various roles within your organization.  How?  There are several ways. But what is critical in the process is to not to think of the training in terms of reading the document from start to finish for comprehension to take place.  Reading the document is important. However, do you really need to know who the author, reviewer, and final signer are for you to understand what you’re supposed to do?  Probably not.

Design Training Right

When designing SOP training, think of the audience, their level of experience with the SOP, its corresponding content, the level of interest and motivation they might have, and how the SOP will help them.  If there is difficulty answering these questions, something is amiss.  Either the SOP is unwarranted, no audience analysis has been taken into consideration for the training effort, (a mistake), or training is not that important.

An approach that helps to make SOP training more effective is to present:

  • the rationale
  • the key takeaways from the SOP
  • what has changed (if this is a revision to the SOP)
  • what tasks and procedures a learner may be responsible for
  • a little history on how the SOP came to be in the first place

Often there is quite an interesting history and rationale on how and why an SOP came to be, what problems or risks it is attempting to mitigate, and how it can make a person, role, department or organization better by following it.  By taking this approach, learners can more readily understand and assimilate the key points of the SOP.

Furthermore, by taking this approach, a template can be created that includes the following key aspects of the document:

  • SOP History and Background
  • SOP Rationale
  • Important Changes
  • Key Tasks and Procedures
  • SOP Impact

This template can then be populated for all SOPs to make the creation of training more efficient.  Even SOP authors can be called upon to help with the creation of training as they are often the resources that hold the true understanding, background, and rationale of the SOP. By moving from the reading a document to one of true education and learning, SOP training can be greatly improved in the pharmaceutical training world.

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