Document templates for medical writers
A document template provides a reusable starting point for a new document. It can supply formatting, structure, reusable text and automation, while the writer remains responsible for the content.
Template files and starting documents
A template is a file used as the starting point for a new document. The adoption of the electronic common technical document reinforced the importance of templates in medical writing.
An ordinary Word document used as a starting document has a .doc or .docx extension and can be edited freely; a Word template file has a .dot, .dotx or .dotm extension and supplies predefined formats and styles. Word 2007 introduced the XML-based .dotx and .dotm formats: .dotx does not store macros, whereas .dotm can. Before Word 2007, templates used .dot.
A default blank Word document is based on the Normal template, which supplies basic styles and automation; the file was Normal.dot before Word 2007 and Normal.dotm from Word 2007 onwards. Creating a document from a template does not modify the template itself. Custom templates are usually saved in the version’s template folder, whose location varies by version and platform.
Examples of template-file locations for older Word versions were listed in 2012.
| Word version | Template-file location |
|---|---|
| 2003, Windows | C:\Documents and Settings\[user name]\Application Data\Microsoft\Templates |
| 2007, Windows | C:\Users\[user name]\AppData\Roaming\Microsoft\Templates |
| 2008, Mac | Macintosh HD:Applications:Microsoft Office 2008:Office:Media:Templates |
| 2010, Windows | C:\Users\[user name]\AppData\Roaming\Microsoft\Templates |
| 2011, Mac | Macintosh HD:Applications:Microsoft Office 2011:Office:Media:Templates |
The username placeholder denotes the computer user’s name. In Windows Vista or Windows 7, searching the Start menu for %appdata%\Microsoft\Templates located the template folder.
Kinds of template
Several different starting points are called templates.
| Kind | What it provides |
|---|---|
| Built-in or vendor-supplied | Ready-made formats supplied with the word processor or through its online gallery, from letters and fax cover sheets to blog posts, proposals and invitations; these may not suit medical writing. |
| Self-made | Styles defined by the writer and saved as a template file, which can be shared with others. |
| Guidance | Publisher, journal or regulator templates with standard headings, subheadings and instructions; styles may or may not be defined. Publishers and journals usually include them in author instructions, while regulators make some available free. |
| Commercial | Purchased templates designed by technical specialists, commonly Word-based with plugins and macros for long, complex documents, often supplied as content-template sets within document-management packages. In 2014, Word classified these as installed templates. |
| Reused old document | A previous document with its text deleted but headings retained; unwanted headings and rogue styles may be inherited, making it a poor foundation. |
A regulatory guideline can supply outline and content for constructing a template without itself being a template file. By 2012, most large pharmaceutical companies had developed their own templates or adopted vendor sets, with or without customisation.
Content and automation
A basic regulatory template should define page orientation, margins, headers, footers, styles and fonts. Document-specific templates can add outline headings, boilerplate and reusable table formats. Preset heading styles, contents-list field codes, and table and figure captions support automatic tables of contents and consistent document structure. More sophisticated templates add custom toolbars for multi-step operations such as creating a particular table format.
The extent of reusable content depends on the document and development phase. Repeated pharmacokinetic parameter descriptions can become phase 1 protocol boilerplate; separate templates can cover bioavailability, food-effect and drug-interaction studies, or one template can include optional text for different designs. A regulatory-agency meeting package varies with the meeting’s purpose and is less suited to extensive boilerplate, but can still use company margins, headers, pagination and fonts.
Benefits and limits
Templates maintain consistent formats and styles across documents, multiple authors and global dossier teams, supporting guideline and company standard-operating-procedure requirements. Standard headers and reusable text also support corporate identity across ordinary business documents. Consistent structure helps reviewers find the same subject in the same place across documents.
Regulatory templates should support eCTD formatting requirements, correct section numbering and headings, appropriate fonts, and electronic publishing that combines documents into a dossier. Deep heading structures, such as those of an investigational medicinal product dossier, can be difficult to manage without familiarity with Word numbering.
Predefined headings, styles and formats let writers concentrate on content, while plugins and macros can shorten repetitive operations. A Word 2007 example compared at least nine steps for adding a landscape page to a portrait document with two clicks using an installed template, without header or footer alignment problems; a pharmacokinetic-symbol menu offered another shortcut.
Documents can acquire inconsistent formatting through other users’ defaults, pasted formatted text or newly created styles, sometimes leaving almost every paragraph formatted differently. Commercial templates can protect styles against alteration or renaming and provide repair tools and technical support for formatting damage, lost cross-links and unstable autonumbering. A template nevertheless cannot guarantee that unwanted styles will never enter a document.
Commercial-template costs can include a one-off licence plus paid updates or an annual subscription. Rigidity may constrain a writer, and reliance on macros or plugins can erode familiarity with standard word-processor functions that are needed in an environment without the template. Large companies with extensive pipelines may be able to afford packages that remain out of reach for startups.
Templates can efficiently produce standardised, regulatory-format-compliant documents, but do not guarantee content quality; responsibility remains with the writer.
Vendor assessment
Vendor claims should be checked against practical selection criteria.
- Ease of use: A moderately skilled word-processor user should need minimal training; otherwise the package may reduce productivity.
- Effect on Word: Macros and plugins should preserve standard functionality and avoid drastic slowdowns; people without the template should still be able to read and edit its documents.
- Stability: The package should be acceptably stable; the vendor should explain its stability-testing procedure.
- Technical support: A minimum support service should accompany the package. Manuals and online resources help, but a hotline can be crucial during a deadline-related failure.
- Adaptability: The template should accommodate regulatory and regional changes, including switching between US Letter and A4 without damaging the document.
- Price: Cost should be proportionate to the number of writers and regulatory documents served.
In 2014, freely available comparisons of regulatory-template functionality, price and market share were scarce.