Document templates and dot files: medical writing improvements for study-related documents

Richard Watson

By Richard Watson - Snr. Director Medical Writing

One characteristic shared by most medical writers is their ability to adapt to different sponsor requirements.  Unfortunately, that adaptability is sometimes stretched to the limit and things can turn rather ugly when document formatting falls apart.  The writer then focuses so much attention on the formatting of a document that the scientific reporting of results suffers.  A solution is the development of document templates that not only comply with current guidelines but which are also stable and easy to work with.  The document templates can be paired with a unique Microsoft Word dot file, which provides everything the medical writer needs to compile high quality study documents.

Sponsor templates and dot files

Sponsor templates vary significantly in their design and level of sophistication and some of these templates are provided by third-party vendors.  Although sponsor templates are generally well designed and present medical writers with few problems, there is one major limitation in their use.  Due to copyright laws and other legislation, sponsors are unable to provide clinical research organisations (CROs) with the actual dot file.  This prevents writers from using the functionality that the template is designed to provide.  These commercially available templates were primarily designed for pharmaceutical companies who perform their medical writing in-house.  You may ask why CROs do not use the same dot files.  The problem is that some sponsors customise their dot files by using different styles or fonts.  Because there may not be two different copies of the same dot file in the same folder, if one sponsor has, for example, changed the default font from Times New Roman to Arial, it is not possible to use the same dot file for any other sponsor.  It is possible to move the dot file to a different folder but this is not ideal.  It is also not always possible to exactly match sponsor customisations, which may alter the sponsor’s preferred styles and formatting.
A number of sponsors have developed in-house dot files to accompany their document templates. These vary in sophistication and the majority are easy to work with.  Unfortunately, not all of these sponsors provide the CRO with a copy of the dot file, which creates the potential for formatting errors and major document issues.  These formatting errors may lead to process inefficiencies, unnecessary increased cost to the sponsor and delayed document delivery.
The majority of sponsors do not have in-house dot files but do provide document templates.  These document templates range in quality from very good to extremely difficult to work with.  One of the reasons for this is the fact that some sponsors may not have the technical know-how/IT skills or knowledgeable resources to develop stable document templates and dot files.  It is this group of sponsor templates that creates the most problems, some of which are only discovered during the publishing process, which can cause major delays at a critical time, for example when aiming to meet submission deadlines.
CRO templates
The most obvious solution to the potential problems associated with sponsor templates may be to use CRO templates, as the majority of CROs have in-house document templates.  However, there are several pitfalls with this approach:
  • As with sponsor templates, some CROs may also not have the technical know-how/IT skills or knowledgeable resources to develop stable document templates and dot files, which might result in document templates that are not ideal to work with and that might introduce additional unforeseen issues.
  • CRO document templates are often reviewed by sponsors when a decision is made as to whose templates to use for a project.
    • In order to protect their intellectual property, CROs will often provide sponsors with an incomplete template, and may choose to provide a PDF version, consisting of mainly section headings etc.  This decision could count against the CRO as it does not provide the sponsor with enough information to make an informed decision.  For example, sponsors may be unaware of the CRO’s toolbar or dot file capabilities, or their ability to effortlessly customise the template to meet the sponsor’s requirements.  The functionality included in the dot file may be the key component that reduces writing time, increases accuracy and ultimately delivers a quality document.
    • Sponsors may prefer to use their own template after this review and the decision may be based on several factors, such as overall layout and design, or styles and formatting.  As explained earlier, this does not always result in a good quality document and may not be advantageous to the medical writer.
Advanced stable document templates
An advanced and somewhat unique solution offered by ICON is the introduction of a template design service, which ensures that documents are stable, easy to work with, and empowers writers and reviewers with the knowledge that the styles they are using will not cause any serious formatting issues.  The level of assistance can be adapted to suit the sponsor’s needs and can range from a basic document template with proper style formatting to improve stability, using the sponsor’s boilerplate text, to something as complex as a fully functional Microsoft® Word dot file.  The dot file can also be customised to meet sponsor needs, starting with a basic toolbar (Word 2003) or custom ribbon (Word 2007/2010), providing access to the appropriate styles or simpler ways to insert tables and figures with consistent formatting and design.  With this approach, the sponsor will receive not only the quality documents that they expect, but they can also be provided with a set of document templates, all formatted to their specifications and 100% compliant with their in-house style guides, as well as a bespoke dot file that brings everything together.  With this approach, everyone at the sponsor and the CRO will have access to the exact same templates and dot files, which will improve document quality significantly.  This will allow faster production times, reduce review cycles, lead to fewer issues during the publishing process, increase the likelihood of meeting submission deadlines, reduce costs and improve synergy (such as reducing the costs of developing documents of a similar kind).


  • Medical Writing