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In clinical research, is there a difference between guidance documents and SOPs?

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I often come across perceptions of SOPs as formal (“boring”) must follow documents, whereas guidance documents, such as work instructions (WIs), are considered less so. I’ve often wondered why that’s the case.

In quality management terms, an SOP is defined as a method for accomplishing policy. As a procedural document, it provides instructions on how to carry out policy. In effect, SOPs represent the action plan for achieving policy.

In clinical research terms, GCP SOPs also translate the regulatory requirements that must be satisfied in conducting, recording and gathering clinical research data about investigational medicinal products or IMPs.

But, different organisations may describe their SOPs in different ways, reflecting their everyday business practices, using: standard practice instructions; departmental operating procedures; or, business practice worksheets.

What do you call yours?

Sometimes these terms are interchangeable. Sometimes they’re not. For example, WIs often reflect local or regional differences in procedures.  SOPs are then considered global ‘higher-level’ documents outlining the general concepts (and reasons) behind particular procedures. Since they lack the detail of WIs, they may need less frequent updating, while still remaining accurate in their high level (outline) state.

By contrast, if WIs form the “how to do it” part of the procedure, broken down into its constituent tasks, then it’s often considered more flexible to modify these procedural parts as often as necessary, instead of the whole SOP. Perhaps precisely because WIs provide more detail, they make more sense than outline SOPs.

Do the SOPs in your organisation make sense to you? If they do – great. If they don’t, then you need to ask yourself – why? Is it just you that has a problem, or do others find them just as much of a mystery?

In any event, both types of document should ensure consistency of procedural practice  since clinical research activities are governed by regulatory requirements. Either way, auditing will pick up on potential gaps or disconnects within or between these two types of documents. So, in answer to this post’s title question – regardless of how you document your procedures (i.e. in a SOP or in a guidance document/WI) – it makes no difference to how regulatory inspectors assess your organisation’s compliance with GCP.

The question then becomes – how can we improve our SOPs or WIs so that they’re easier to follow? Maybe a topic for future discussion? What do you think?

Let me know your thoughts, comments or questions.


About Dr M

I'm a pharmaceutical industry specialist, with more than 25 years experience, and a background in medical and social sciences. My focus lately is on helping ABPI exam candidates navigate the ins and outs needed to sail through this pharmaceutical industry rite of passage.


4 thoughts on “In clinical research, is there a difference between guidance documents and SOPs?

  1. A good starting point is to purchase a set of GCP compliant templates. (often less than $1000) that will save you the headache of writing them and making sure they are compliant. Make sure they are customizable to fit the site and/or protocol. This will decrease a lot of potential for missteps. Here is a good article on the need for compliance: http://www.omniavincit.com/index.php?option=com_content&view=article&id=23&Itemid=27

    Posted by Jeremy Wilkerson | March 17, 2011, 7:00 PM
  2. good topic..

    nicely explained

    Posted by sapala organics | August 12, 2011, 11:29 AM

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