Templates: the basics of document automation.
There is no right or wrong regarding what a template should include, but a good basic template for regulatory documents should contain certain rudimentary elements, such as page orientation, margins, headers, footers, styles, and fonts. More sophisticated templates can be document-type specific by including the headings (outline) of the document, boilerplate text, and table formats that are reused to generate similar documents. Such customized content could still be a basic Word document that can be modified at will by the writer, with the file extension of ".doc," or the content could be a programmed set of styles that can be attached to any new Word document, to help ensure that preferred styles are maintained per regulatory specifications. The latter is likely to have a ".dot" file extension and, as a true programmed template, it must be housed in a specific location on your hard drive, where it will be available to you whenever you need it. A sophisticated template will also include its own custom toolbar nestled in the Microsoft toolbar, with custom tools that reduce the time required to perform specific functions (ie, create a specific table format with only a couple of clicks).
Before WordPerfect and Microsoft Word became available in the early 1980s, creating documents electronically was accomplished either through text editing programs used primarily for computer programming or dedicated word processors such as those put out by Wang Laboratories, Inc. (2) or IBM. (3) The default output formatting depended on the printer available to the text-editing system (eg, an IBM Selectric typewriter hooked into a mainframe computer) or word processor. Once word processing software was developed that was not dependent on a particular computer brand, the initial formats of documents could be specified so that the resulting documents have the same basic format without requiring the document authors to specify these defaults each time a new document was created. Successive updates of these software packages introduced "styles," which were combinations of formats of fonts, line spacing, and other character or paragraph attributes grouped under a single name that could be invoked from a styles menu. Toolbars with groups of commands clustered together by function could be invoked by single mouse clicks, and macros-custom mini-programs made available to the user through the template. Today, writers are able to design styles that are limited only by their imagination. However, because we are writing global regulatory documents, we need to save our stylistic imaginations for the party invitations we'll send after we have successfully submitted documents created in accordance with regulatory style specifications.
The properties of Word templates underwent a radical change between the Word 2003 and 2007 versions. When Word 2007 was released, the templates and styles were created to include XML capabilities, allowing users to "tag" bits of information for storage, similar to a database for content. As such, where older versions of Word used a single type of template with the extension ".dot" to create documents that had the extension ".doc," the newer versions now had two different types of document templates, identified by the following file extensions:
.dotx indicates that the template is XML compliant but does not have macros enabled and creates documents with a .docx extension.
.dotm indicates that the template has macros enabled in addition to all the other properties found in a .dotx template and creates documents with a .docm extension
Of note, many companies are still using versions of Word that create ".doc" and ".dot" files, sometimes because they think that the learning curve associated with upgrading to a more current version of Word is not worth the time it takes staff to adjust or the economic impact on other in-house legacy systems. Although Microsoft has been proactive in enabling some XML capabilities, few regulatory writers use the XML features on an individual document level. So, if you use one of the more advanced Word versions, consider yourself ahead of the curve, but if you still use some other version, availability and usability trump having the cutting-edge software.
All Word documents are based on at least one template, known as the "Normal" template (also called the global template). This template contains the basic style set and automation for all documents that may be created with the installed version of Word. When Word is started and a blank document appears on the screen, it is based on this Normal template. This template is named "Normal.dot" in pre-2007 versions of Word and "Normal.dotm" in versions 2007 and later.
In addition to the Normal template, all versions of Word after 1995 have come with a variety of templates for creating various documents, such as letters and fax cover sheets, but the real power for users is the ability to create custom templates designed for their specific needs. These will usually be saved to the template folder of the version of Word in which they are created. The location of the user template files varies with the version of Word (Table 1). If you use the Windows Vista or Windows 7 operating systems, you can search for the template folder location by going to the "Start" menu and using the search term %appdata%\Microsoft\Templates.
Using more sophisticated templates to create regulatory documents empowers the regulatory writer with company approved styles, field codes, boilerplate text (ie, either headings or reusable statements), and additional toolbar icons to reduce the number of keystrokes for formatting (eg, headings, superscript and subscript, bulleted or numbered lists, in-text tables). Styles contain format commands, but also contain codes that can be picked up by other functions in Word. For example, when a heading style is used in text, the table of contents (TOC) can be automatically generated with the applicable TOC level heading. The text of the standard headings, pre-set field codes for TOCs, table and figure captions, etc, are ready for use in any document based on the template. Unlike the documents that are created from the template, the template itself is not modified in any way when it is invoked in creating a new document. That is not to say that a template can ensure that no unwanted styles are introduced; regulatory writers must learn the tricks of the trade to prevent this. (You can find tips in the online version of the June issue of the Journal.)
Most large pharmaceutical companies have developed their own templates or have adopted (with or without customization) a set of templates that are offered by a number of vendors. Regardless of the originator, many regulatory documents start with the International Conference on Harmonisation (ICH) guidelines, which provide the basic outline and content. These guidelines are not templates, per se (ie, they are not ".dot" documents), but they do give enough information to facilitate the creation of templates for protocols and investigator brochures (E6 guideline (4)), clinical study reports (E3 guideline (5)), and the summaries that make up Module 2 of the Common Technical Document (M4 guideline (6)). Templates created for these complex documents ensure built-in consistency and global structural familiarity that make it easier for the reviewer (be it the statistician down the hall or the medical officer at the FDA) to find subject matter in consistent locations across documents.
The extent of the template may also vary with the phase of the drug development. For instance, you could incorporate the descriptions of many of the pharmacokinetic parameters used in protocols for Phase 1 studies into a template as boilerplate text. You could even create a protocol template for each specific type of Phase 1 study you repeatedly run (eg, bioavailability, food effect, drug interaction). Alternatively, you could create one protocol template that would cover all Phase 1 protocols and include optional text depending on the specific design of the study. Other documents may not be appropriate for extensive templates: background packages being prepared for meetings with a regulatory agency, for example, will contain content that is dependent on the reason for the meeting. However, even documents that don't lend themselves to common headings and boilerplate text could start from a template consisting of company-specified margins, headers, pagination style, font, etc.
In conclusion, knowledge of templates, their properties, and the ability to customize them can help the medical writer streamline document creation and facilitate review by presetting formats and automating routine tasks.
Author disclosure: The authors note that they have no commercial associations that may pose a conflict of interest in relation to this article.
Author contact: d.benau@Usciences.edu.
(1.) Definition of template. http://www.merriam-webster.com/ dictionary/template. Accessed March 12, 2012.
(2.) Benson R. Wang Laboratories: from custom systems to computers. September 2011. www.oldcalculatormuseum. com/d-wangcustom.html. Accessed May 18, 2012.
(3.) IBM 5520 Administrative System. www-03.ibm.com/ibm/ history/exhibits/pc/pc_5.html. Accessed May 18, 2012.
(4.) E6: Good clinical practice. http://ichgcp.net/ 6-clinical-trial-protocol-and-protocol-amendments. Accessed March 12, 2012.
(5.) E3: Structure and content of clinical study reports. www.ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/ Efficacy/E3/Step4/E3_Guideline.pdf. Accessed March 12, 2012.
(6.) M4: The common technical document. http://www.ich.org/ products/ctd.html. Accessed March 12, 2012.
By Danny A. Benau, MSOD, PhD; [a] Barbara Snyder, MA; [b] and Peggy Boe, RN [c]
[a] Director of Biomedical Writing Programs, Associate Professor of Biomedical Writing, Mayes College of Healthcare Business and Policy, University of the Sciences, Philadelphia, PA; [b] Director of Medical Writing, Warner Chilcott (US), LLC, Rockaway, NJ; [c] Medical Writer, Research Pharmaceutical Services Inc., Wilmington, NC
Table 1. Common Locations of Template Files in Versions of Microsoft Word Word Version File location 2003 (PC) c:\Documents and Settings\[your user name] Application Data\Microsoft\Templates 2007 (PC) c:\users\[your user name]\AppData\Roaming Microsoft\Templates 2008 (Mac) Macintosh[R] HD: Applications: Microsoft office 2008: office: Media: Templates 2010 (PC) c:\users\[your user name]\AppData\Roaming Microsoft\Templates 2011 (Mac) Macintosh HD: Applications: Microsoft office 2011: office: Media: Templates Note: (PC) is the MS Windows Operating System; (Mac) is the Apple Macintosh Operating System; [your user name] is the user name that you use on your own computer
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|Title Annotation:||Regulatory Insights|
|Author:||Benau, Danny A.; Snyder, Barbara; Boe, Peggy|
|Publication:||American Medical Writers Association Journal|
|Date:||Jun 1, 2012|
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