Designing Fit-for-Purpose SOPs: Boilerplate Language

In our next blog post on designing fit-for-purpose SOPs, we consider the value of boilerplate language in SOPs. Boilerplate language can help us "save ink" by using and re-using the most efficient language to describe a step.  It also helps improve reader comprehension, because they are seeing familiar language - no need to re-interpret. Boilerplate language can also help get us over some rough spots in writing SOPs.  For example, many sponsors struggle with how to represent the concept of "delegation" in an SOP.  Rather than peppering a document with "or designee" dozens of times, we like to use this in the responsibilities section:

The roles named below may delegate activities to a qualified resource, but they remain accountable for assigned steps.

We also see a lot of ink devoted to development of protocols and study-specific plans. Do your staff really need to be told to email drafts, schedule review meetings, and incorporate comments?  We find that multiple steps can be subsumed into one sentence:

The [responsible party] drafts the [document], facilitates review by [X,Y, and Z], approves the plan, obtains approval from [X and Y], and files the document in [repository].

If a vendor is writing the document, but the sponsor still needs to review and approve, the step can be expressed like this:

The [responsible party] works with the vendor to oversee development of the [document], facilitates sponsor review by [X and Y], and approves the [document].

If a vendor completes a step per the vendor's SOPs, but the sponsor still wants the SOP to include completion of that step, the following statement is useful:

The [responsible party] verifies that the following steps have been completed...

What if the sponsor usually outsources an activity, but also may perform it in-house?

The [responsible party] completes the following steps, or verifies completion by the contracted vendor...

When it comes to SOPs, repetition is good!