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Why and How to Conduct a Strategic Review of Regulatory Documents

November 16, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing and Corporate Communications | Medical Writing Services

As regulatory medical writers, we are trained on how to write for regulatory audiences, but how often are a Sponsor’s project teams trained to review the regulatory documents we write? At IMPACT, our answer is – as often as possible.

We encourage our project teams, as well as our internal staff, to use strategic review practices whenever possible, to ensure an effective, efficient review. We have trained internal and external reviewers accordingly, both with excellent results.

In this post, we’ll share the keys for an effective strategic review of regulatory documents. Please consider following these tips during your next review and let us know how it goes!

What is a strategic review?

First things first, what do we mean by strategic review? Call it what you want (and we’ve heard many names for it – content review, SME [subject matter expert] review, or, as I prefer, strategic review), but it is essentially a review of a document to ensure the accurate interpretation of the data being presented and the effective communication of messages based on those data.

A QC review is for data accuracy, style, etc. A strategic review is NOT a QC review, nor is it wordsmithing/copy-editing. Wait – that’s worth repeating (and in bold red font).

A strategic review is NOT wordsmithing/copy-editing.

Rather, the ultimate goal of a strategic review is to make sure the document you are reviewing meets its goal within your development program. If reviewing a CSR, do the conclusions address the objectives that the study was conducted to meet? If reviewing a submission document, does it support the key messages in the label?

Make sense?

The figure below illustrates some key elements to an effective strategic review.

Who conducts a strategic review?

This is an easy one. Everyone who reviews a regulatory document! For most regulatory documents – let’s use CSRs and submission documents again as examples – there are multiple reviewers from various disciplines (eg, stats, clinical, safety, clin pharm) on a review team.

Each of those reviewers should conduct his/her own strategic review of the document. The important point here is that each reviewer should “stay in their lane.”

What does this mean? It means each reviewer should provide their primary review based on their area of subject matter expertise (eg, safety or clin pharm).

This approach relies on trust in all team members, not only that they stay in their lane, but also that they provide a meaningful and thorough review of their subject matter and allow the other subject matter experts to do the same.

Why should I conduct a strategic review?

This is an easy one too. Removing the need for any given reviewer to edit, QC, or review areas of expertise outside of their own provides for a much more efficient and effective review. Every single time.

Try it, I promise it will work more effectively than all team members reviewing and wordsmithing the whole document.

How do I conduct a strategic review?

Ok, now we’re getting down to the nitty gritty. Hopefully I’ve already convinced you that strategic reviews are effective. Now, I’ll provide some handy tips for how to conduct one:

1. Focus on your area of expertise.

Ok, ok, I know that’s the same as “stay in your lane,” but it bears repeating. The success of strategic review relies on each reviewer focusing on his/her area of expertise, and trusting his/her teammates to focus on theirs.

Specifically – focus on whether the data related to your field are interpreted correctly and the messages about those data are communicated accurately, articulately, and effectively.

Importantly, the use of a strategic review system needs to be agreed to BEFORE review begins so that all reviewers understand their review remit.

2. Do not wordsmith, copy edit, or QC.

Again, I’m repeating myself, but it’s worth repeating. Everyone writes differently, so unless something is grammatically incorrect or wording is so unclear that data interpretation is obscured, try to avoid changing a writer’s style. Instead, make “value added” review comments and ensure that the document is “fit for purpose,” rather than that it is written in your preferred style.

3. Provide specific comments and propose preferred wording.

When you find an area of messaging that you want to comment on, don’t leave an open-ended comment (eg, “this doesn’t make sense”). Instead, provide specific information (eg, “this may not make sense to a non-statistician. I propose that we revise as XYZ”.) Can you see how the latter comment would be much more helpful and efficient for a writer?

In addition to being helpful to the writer, this approach also provides assurance to the reviewer that their preferred wording/message will be presented.

4. Always review with the key messages in mind.

It’s important that every member of the team know the purpose of this document in the drug development program, and review it accordingly.

For example, all clinical studies begin with the intent of ultimately being included in a marketing application – so when reviewing a CSR or other study-related document, remind yourself of the role of your study in the program, the objectives you set out to meet, and review with those key messages in mind.

And if you are at the stage of submitting a marketing application, review with the ultimate key messages in mind – the messaging in your product label.

5. Put yourself in the regulatory reviewers’ shoes.

While you’re focusing on your area of expertise and providing specific, value-added comments about key messages, be sure to keep your ultimate reviewer (at the regulatory agency) in mind. Well-written documents are critical for success.

I hope you’ve found these review tips helpful! If you’d like to hear more, or have any questions or feedback on what has or hasn’t worked for you when conducting strategic reviews, don’t hesitate to contact us. We’d love to hear from you!

Category: Medical Writing Services
Keywords: strategic review, regulatory medical writing, CSR, submission documents

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