Document templates for medical

writers
Correspondence to:

Raquel Billiones Raquel Billiones

Clinipace Worldwide
Clinipace Worldwide, Volketswil (Zurich), Switzerland Volketswil (Zurich)
Switzerland
[email protected]

Abstract
A document template is defined as ‘a file that serves many different forms. The most common examples
as a starting point for a new document’. This article are listed below.
looks at the specialised templates used by medical
writers in their trade with a focus on the commer- Built-in word templates
cially available products. Templates allow a Ready-made templates for Word are available from
medical writer to prepare standardised documents office.com. These range from templates for blog
that comply with the regulatory format require- posts to project proposals to party invitations
ments, and they increase productivity and allow (Figure 1). These are especially handy for the
rapid troubleshooting and document repair. The average Word user. Unfortunately, they are not
advantages and the disadvantages of using tem- necessary suited to medical writing needs.
plates and some criteria of what makes an effective
template are discussed. Templates available com- Self-made templates
mercially are briefly presented. For the more technically inclined who aims for indi-
viduality, one can create a template in Word by defin-
Keywords: Templates, Regulatory, Documents, ing different styles. The template can be saved as a
Commercial ‘.dot’ file. These files can even be shared with the
Word user community on office.com.

Introduction Old documents as templates

In the medical writing world, we are frequently
The etymology (1670s) of the word ‘template’ is
asked to use old documents as ‘templates’ by delet-
rooted in craftsmanship, with definitions ranging
ing the existing text but retaining the headings and
from a ‘weaver’s stretcher’ to a ‘plank or rafter’
the subheadings that are usually standard for that
that provides support or serves as guide for a
specific document. Unfortunately, these old docu-
piece of work.1 Centuries later, templates in many
ments may come with a lot of baggage, including
different forms still play an important role in pro-
unruly headings and rogue styles and are therefore
fessional life. For medical writers, templates are a
not the ideal foundation for a new document.
part and parcel of the job and the advent of eCTD
reinforced their importance. This article looks at
Guidance templates
the templates used by medical writers in their
Publishers and journals usually provide templates
trade, with a focus on the commercial templates
as part of their Instructions to authors. For
used in regulatory medical writing.
example, MEW has one available for feature articles.
Regulatory bodies provide templates for certain
Different types of document
regulatory documents that can be downloaded for
templates
free. These templates contain standardised headings
In Microsoft Word®, a document template is ‘a file and subheadings as well as instructional texts but
that serves as a starting point for a new document’.2 the styles may or may not be defined.
This file contains pre-specified formats and styles
and has the file extension ‘.dot’. When you create a Commercial templates
new Word document, by default, it is formatted These are ready-made templates designed by techni-
based on the normal.dot template. However, tem- cal professionals and must be purchased. Although
plates can actually mean many things and come in most of these are Word-based templates, they come

© The European Medical Writers Association 2014

DOI: 10.1179/2047480613Z.000000000189 Medical Writing 2014 VOL. 23 NO. 1 17
Billiones – Document templates for medical writers

Figure 1: Office.com templates available in MS Word.

with extra plugins and macros that facilitate the In medical regulatory writing, templates give
writing and development of long and complex different documents a uniform look. Whether they
documents. These usually come as part of a set of are used by multiple writers working on a single
content templates included in a document manage- document or by a whole global team working on a
ment package tool. Word classifies these as set of documents for a dossier, templates (and the
‘installed’ templates. standard headings, and boiler plate and instruc-
tional texts therein) ensure that the documents are
Why use templates? Why not? standardised in terms of formats and styles as
There are pros and cons associated with using tem- required by the guidelines and company standard
plates, and they are discussed here with a focus on operating procedures.
the commercial templates in regulatory writing.
Pro: Regulatory compliance
Pro: Standardised documents In the pharmaceutical industry, templates have a
Companies, regardless of industry, require the use more specific and crucial function – guidance com-
of templates in their documentation mainly to main- pliance. Regulatory templates are supposed to be
tain a degree of consistency in the many documents designed to comply with the eCTD format require-
that their employees write every day, from internal ments and to facilitate electronic submissions by
office email memos to full project proposals. providing correct section numbering and headings.
Templates help maintain corporate identity by For those who are not familiar with regulatory
using standard headers and prespecified texts. medical writing, the investigational medicinal

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 Billiones – Document templates for medical writers

Figure 2: A part of the table of contents of an IMPD.

product dossier (IMPD) is a good example illustrat- template I am currently using, it can be accomplished
ing the complexity of regulatory documents. The in two mouse clicks (Figure 3), without having to
headings and the subheadings in an IMPD (see worry about header and footer alignments. Another
Figure 2) can be challenging for a writer not familiar useful feature is the pharmacokinetics symbols
with Word numbering functions. available in a pulldown menu (Figure 4).
Another issue is the font type and size. The regulat-
ory writers are aware that most regulatory agencies Pro: Rapid troubleshooting and repair
prefer Times New Roman, Arial, and Courier New Many medical writers have experienced how docu-
with a minimum size of 9 point.3 The newest Word ments that have changed hands during the writing
versions include Calibri as the default font for the and review process can come back with bizarre
body text in a new document. This can easily be mis- formats and styles. Some of these changes may
taken for Arial, but it is not the same. In addition, have been inadvertent, having been ‘infected’ by
Word offers many fonts that unfortunately have no styles defined in other normal.dot files. Copying
place in a regulatory document. and pasting formatted text can also introduce
Beyond the writing itself, the templates should rogue styles into documents. However, there are
also work seamlessly with electronic publishing, also users who just cannot resist changing or even
which compiles different documents into a single creating new styles. A document may end up suffer-
electronic dossier. ing from the so called ‘snowflake syndrome’, which
is where almost no two paragraphs are formatted
Pro: Increased productivity alike.4
By pre-defining headings, styles, and formats, the
templates allow the writer to concentrate on generat-
ing content rather than (re)formatting. Template
plugins and macros, which appear as icons in the
Word ribbon, enable the writer to carry out compli-
cated commands with a single mouse click. For
example, inserting a landscape page in a document
that is in standard portrait layout takes at least nine Figure 3: Icon in MS Word ribbon for inserting and
steps to accomplish in Word 2007. With the ‘installed’ removing a landscape section in a portrait document.

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Billiones – Document templates for medical writers

What makes a good template?

Not all that glitters is gold. Some templates and
document management tools may not actually live
up to their claims. In shopping for templates, here
are a few suggested criteria to consider.

Ease of use
The template and its accompanying plugins should
be easy to use, otherwise it will decrease rather than
increase productivity. A user with a moderate level
of Word skills should be able to use the template
with minimal training.

Effect on word functionality

Macros and plugins should not interfere with the
standard Word functionality or drastically slow
down any standard software. In addition, the docu-
ment should still be readable and write enabled by
other users who do not have the template installed
in their computer.

Stability
The template should be acceptably stable and not
lead to too many ‘crashes’. Ask the vendor for
their stability testing procedure.

Technical support
Figure 4: PK symbols from a pull-down menu in MS
Word ribbon. A minimum degree of technical support should come
with the template package. User’s manuals and online
resources are useful, but a hotline can be crucial when
Templates solve this problem by including for-
a template crashes while chasing a deadline.
matting styles that are protected and not easily
altered or renamed no matter how many times the
Adaptability
document changed hands.
The drug regulatory process is continuously evol-
Word has other quirks and instabilities, like the
ving and so are the documents that go with it. The
nightmare of disappearing cross-links and out-of-
template should therefore be adaptable to changes
control autonumbering. Commercial templates
in regulations or region specific requirements. The
have (theoretically) been tested for stability, and
simplest example is changing a document from US
they have builtin repair systems that help fix format-
Letter to A4 size. Does your template allow this
ting issues. The snowflake syndrome, for example,
without breaking your document apart?
can easily be repaired with a few mouse clicks. In
addition, for dire cases, there is usually technical Price
support that can be contacted. Finally, the price of the template is, of course, of
prime importance. Normally, to justify the cost of
Cons of using templates buying a set of templates, a certain critical mass of
The main disadvantage of the commercial writers and regulatory documents is needed. Over
templates is the financial aspect, which can the years, my experience is that big pharma compa-
range from a one time licence fee ( plus extra for nies with an extensive product pipeline can afford
updates) or an annual subscription fee. Another (and should have) these templates, whereas startups
objection to the templates is their rigidity, which cannot necessarily afford them. In a 2010
may ‘cramp’ the style of some writers. Commercial Europharm survey, only 44% of small- and
templates also make the writer dependent on the medium-sized pharmaceutical enterprises in
macros and plugins, causing them to forget the Europe had an eCTD management tool. The rest
standard Word functions in a template-free were, at the time, still checking out vendors or
environment. opting to outsource the eCTD publishing process.5

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 Billiones – Document templates for medical writers

Commercial templates: What’s Templates are an important part of medical

available? writing. However, take note that I never used the
term ‘quality documents’ in this article, a buzz
Many software companies offer regulatory tem-
word that template vendors like to use. Templates
plates. Unfortunately, almost no data are freely
enable medical writers to efficiently prepare stan-
available comparing the functionality, the price,
dardised, regulatory format-compliant documents.
and the market share of these software packages.
However, at the end of the day, templates do not
Two of the most popular template sets are
guarantee quality documents. Like the weaver and
ISIWriter™ and Liquent SmartDesk™.
the builder, we, medical writers, are still fully
ISIWriter by CSC prides itself for having been
responsible for the content.
created by ‘expert medical writers’, so it can cater
in a better manner to a medical writer’s needs.
This template set covers the full documentation Disclaimers
workflow from authoring to repairing and publish-
The views and the opinions written here are purely
ing, and promises a ‘submission ready’ end product.
those of the author and do not necessarily reflect
ISIWriter™ boasts of more than 200 content tem-
those of Clinipace Worldwide.
plates for regulatory submissions, including the
different modules of CTD.6 This is the template I
am most familiar with. References
SmartDesk for Authoring™ by Liquent is 1. Online Etymology Dictionary. [accessed 2013 Nov 25].
another document template and authoring system Available from: http://www.etymonline.com/index.
for regulatory writing. It too covers the dossier prep- php?term=template.
2. The Tech Terms Computer Dictionary. [accessed 2013
aration process, including writing, rendering, pub-
Nov 25]. Available from: http://www.techterms.com/.
lishing, and preparing the eCTD. In addition, it 3. ICH M2 EWG Electronic Common Technical
offers a Regulatory and Clinical Services Authoring Document Specification V3.2.2 16 Jul 2008.
Style Manual that facilitates consistency in author- 4. Taming unruly formatting in your Word documents.
ing.7 I have never used Smartdesk™, but I have [accessed 2013 Nov 25]. Available from: http://office.
microsoft.com/en-us/word-help/taming-unruly-for
heard positive feedback from colleagues who have. matting-in-your-word-documents-HA001034921.aspx?
Other template systems include the DART by CTT=1.
Yeldell Scientific and TRS Writer by CSC. 5. Europharm smc. Europharm-smc position paper on
eCTD implementation in Europe May 2010 [accessed
2013 Nov 25]. Available from: http://www.euro
Conclusions pharmsmc.org/default.asp?SHORTCUT=143.
We have come a long way from the weaver’s 6. ISIWriter. Available from: http://www.imagesolutions.
com/isiwriter/. [accessed 2013 Nov 25].
stretcher or the builder’s rafter as templates of crafts- 7. SmartDesk for Authoring. Available from: http://www.
manship. In the digital era, our templates reside in liquent.com/technology/smartdesk-authoring. [accessed
our computers. 2013 Nov 25].

Author information
Raquel Billiones is a life scientist (BSc, MSc, PhD in
Biology) and medical writer with more than 20 years
experience in scientific research, teaching, and writing.
She switched from academia to medical writing in 2006
and never looked back. She is currently working as a
senior medical writer for the digital CRO Clinipace
Worldwide EU HQ in Zurich, Switzerland.

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