Once again I welcome back one of my favorite members of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems, Writer and Regulatory Operations Consultant. He just keeps coming back for more writing!
It’s all you Jake!!
Do you ever feel like all you ever produce is … documents? You might be right!
I’ve written before (https://mccormicklifescience.com/2014/01/) about the importance of having quality (small-q!) documentation. Document management systems, whether electronic or not, however, are only part of the picture. These manage the inter-document control; what about intra-document control? For this, we turn to the humble, hard-working template.
You might think that writing about templates for drug development is a bit off-topic; they’re as mundane and ubiquitous as the coffee we fuel our writing with. In fact, they’re so common, it’s hard to find anything about them beyond how to use them!
But, like coffee, they can be what we make them, and they can have surprising depth and complexity.
What is a template, anyway? At the root, anything that you reuse you can call a template. That last report you dragged up and re-wrote for something else, or a paragraph you cut and paste, even the signature line in your email are templates. But consider that we want to use templates as document control, which means we need to be more thoughtful about it.
There are three types I want to call your attention to: shells, content-rich templates, and tool templates. (To keep things simple, I’m only going to talk about document templates that we use to write, well, documents. Most of our systems and instruments rely on templates to output data or reports, but generally, end users don’t interact with those as much.)
- Shells are the simplest kind of template. They typically have headers and footers, a set of styles, maybe a few section headings, but not much else. Most documents will be written in shell templates, because their content is unique, even if their structure is the same, such as SOPs and eCTD sections.
- Content-rich templates are a major step up in the amount of pre-written text. With these, writing a new document can be as simple as replacing a few numbers and names here and there. Legal contracts are a perfect example of a content-rich template, since the majority of the text is boilerplate that has been thoroughly vetted and approved. Using these templates can save a significant amount of time when writing and reviewing very similar documents.
- Tool templates (my favorite) give you control over a potentially huge array of authoring, formatting, and publishing shortcuts. They can be completely blank or have some degree of shell content, but their magic is all under the hood, typically accessed by buttons added to the program interface.
All of these ultimately have one purpose: to maintain control of your content the same way your documentation system helps to maintain control of your documents. Put another way, templates can grease many of the wheels of the documentation system, from discovery through post-marketing, to facilitate the production of quality documentation.
Consistency in appearance and structure enhances readability, which encourages readers and reviewers to focus on the content rather than spending energy coming to terms with yet another funky looking report. Templates are also the best friend of those who manage the documentation systems of the company, since they provide a consistent foundation for all the documents in their charge.
BUT, just like any system, they’re only as valuable as how they’re used and maintained.
So how do you use and maintain your templates? The same as with your documentation system:
- Consult with your users to determine their needs before designing or purchasing templates. Not every group has the same needs, and the best way to maintain everyone’s sanity (ie, maintain compliance) is to ensure that the templates are fit for purpose.
- Provide training to make sure that everyone understands how to use them. Especially with simpler templates, the burden is on the author to stay within the lines. And with complex tools, such as commercial eCTD template suites, training can unlock their full power.
- Continuously monitor template use for compliance, and be prepared to make periodic updates. After all, the purpose of templates is to enable consistent, quality documentation. If templates aren’t being adhered to, either more training is needed, or they are due for another round of consultation with the end users.
At its best, a well-designed set of templates can save hours of work per document, since a lot of the technical heavy lifting has been done ahead of time. And with some of the advanced functionality available in more sophisticated templates, even more time can be saved at the point of publication. I, for one, am always grateful to have them!
- Do treat your templates with care – if made well, they will be with you for a long time
- Do work closely with your end users throughout the lifespan of your templates
- Use your templates, and stick to them!