Author: Katherine Lalicker, Editor: Ashley Self
Managing your figures, tables, references, and so much more on a lengthy, complex regulatory document can seem impossible. Even seasoned medical writers struggle when trying to make changes or add content without breaking a document. Chances are, the tools you need already exist. Read on to find out how some of the simplest Microsoft Word tools can allow for smooth changes to maintain an organized, uniform document.
CER documents need to be clear and uniform, which can make it difficult to pull content from one document to another without disturbing the style of the document. There are multiple paste options that allow you to either match the formatting of your document or paste text without any formatting. All options can be found under the Home tab on the toolbar in the copy and paste section. Two important functions for CER writing are Match Formatting and Keep Text Only.
A well-designed template functions as a formatting blueprint for your document. While some companies may provide their own template, it is important to be able to create and establish a template to ensure uniformity through your work. With a good template, writers just need to insert the information.
Preset styles found in the Styles section of the Home tab help writers focus on content and quality. Found under the Styles Pane, styles can be quickly modified to match the formatting guidelines for your document. Once a style has been added, it will appear on the styles pane where you can select them when needed.
Additional features such as an automatic table of contents and cross-referencing can also be added to a template.
Useful Tip: You can save your formatting as a template by selecting File – Save As Template.
Useful Tip: Formatting is a meticulous aspect of any complex document. To reveal formatting, click on the paragraph mark located on the Home tab and all formatting marks appear. This tool makes it easier to edit the formatting without losing content.
In large, information-dense documents, it is counterproductive to scroll endlessly to find sections of interest. A well-done table of contents in MS Word makes finding specific content simple. This creates a link between corresponding titles in a table of contents instead of requiring a user to manually insert a cross-reference for each section. A table of contents is easy to insert, but users make some common mistakes that can affect the efficiency of the automated tool.
Formatting styles are critical to creating a table of contents. Word provides preset automated table of contents options that require you to pick a style for each of your title types. You will notice that “Heading 1,” “Heading 2,” and “Heading 3” are located where the chapter titles and sections will be. Applying the corresponding styles, located in the Styles section, will determine the format of your table and which titles are linked.
Decide what text you want to be included on the Table of Contents and use either Heading 1, 2, or 3 – Go to References – Table of Contentson the left side of the ribbon – Choose from the Automated Table of Contents options that are previewed
As a good practice, the table of contents must always be updated at the end of the writing process. Updating the entire table will revise heading changes along with page numbers.
You can modify your table of contents by selecting the Custom Table of Contents option. Changes can be made to the table format and what you want to be included on the table in the dialogue box.
Cross-referencing connects items within a document, similar to a hyperlink, for smooth navigation, which is useful in lengthy documents. You want to use this to ensure the reader can access information quickly without needing to manually search for it. The cross-reference tool can be used to link headings, footnotes, captions, figures, and tables to where they are in the text. Did you know that cross-references can be updated just like the table of contents? Updating is crucial because content is constantly moving around the document from page to page.
To insert a cross-reference, go under the Insert or Reference tabs, and choose the type and caption.
Insert tab: Insert – Link – Cross-reference
References tab: References –Cross-reference
An added benefit to using cross-reference is that it will actively change based on the output. If a document is printed, the cross-reference will change to tell the reader where the content is in printed form.
Some writers recommend this book, Microsoft Word for Medical and Technical Writers, as a good read to familiarize yourself with all that MS Word can do for complex medical writing needs.
When pulling tables from PDF documents onto a Word file, a simple copy and paste doesn’t always do the job, requiring the writer to recreate the table. These tables can include important information on instructions, uses of the product, and complex clinical data.
Once you insert a table, use the table Design and Layout tabs to quickly customize a table. The preset styles are a good place to start and can be altered by selecting the menu under Modify Table Style. A modified style can then be saved so it is available anytime you need it.
A split table can cause confusion, especially when a large amount of information is being presented. To resolve this, we can go under the Table Properties and select Repeat as header row at the top of each page to make sure the headings of the table show up if a large table splits across pages. Additionally, by unchecking the box for Allow row to break across pages, you can also prevent a row from splitting up.
It is common for a company to want their logo and additional information included on the top and/or bottom of a document’s pages. Headers and footers are integral to any document for this reason and include features that can make editing them easy.
Once you have opened the header and footer edit option, either by double clicking one or choosing the option to insert one, the Design tab appears. Here you can choose style, formatting, and content you want to be included in your header and footer.
Headers and footers, like page numbers, can be excluded from the first page.
Including page numbers is critical in any long document, but there are other benefits to using them in technical writing. Page numbers can be used in cross-referencing when the text is referring to information found on a specific page. Page numbers can also be modified to fit the needs, and style, of your document.
By default, a number will always appear. However, you can unmark the box that reads Show number on first page when you are first inserting page numbers. This will turn the second page into “page one” of the document, a useful tool for when you have a cover page.
Many people will likely be reviewing your document, which is why the ability to track each user’s activity on a long document is so important. Word provides tools for tracking changes, edits, and comments. These tools are useful when one or more people are reviewing/editing a document. All of this can be done under the Review tab.
Changes can be tracked by clicking the Tracking menu – turn on Track Changes. Comments can be inserted by selecting New Comment.
All changes and comments will appear on the side of the page and indicate what has been changed in the document and comments that have been made.
Useful Tip: The Navigation Pane makes it easy to view changes and comments. In addition, it includes a tab where you can view your table of contents and click through it without needing to scroll back the top of the document. The Navigation Pane can be made visible under the View tab.
Clinical Evaluation Reports (CERs) often include figures and tables that do not always fit on a regular, portrait-oriented page. Page orientations can be found in the Layout tab. If you have a table or figure that is too wide for one page, it is possible to change the orientation of that single page to Landscape.
Adjusting the orientation to fit specific content saves time and ensures you do not need to alter or potentially lose important information.
Author: Ashley Self
I bet when you became a medical writer, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers, you’re not alone.
A 2017 Project Management Institute study found most project management initiatives fail for a handful of reasons: 37% fail due to a lack of clearly defined and/or achievable milestones and objectives to measure progress, 19% break down because of poor communication and, similarly, 18% fail due to lack of communication by senior management. While no project can be made absolutely foolproof, seasoned medical writers have learned to rely on advance planning and adherence to certain basic guidelines to ensure their projects run smoothly.
For your next project, once the project liaison has met with stakeholders to nail down the scope and budget, use these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements.
Tempted to throw your project calendar out the window after a series of missed deadlines? Consider using a comprehensive project scope and calendar matrix. The matrix should be the product of a detailed meeting with the project stakeholders and leads on both sides, and highlight who is in charge of what deliverables, who is responsible for signing off on that material, and clear deadlines for each. Each section of the matrix should call out not just final due dates from the writers, but also how long the principals have to review submitted sections and how long it should take to make final revisions.
It takes quite a bit of work just to build a matrix that will cover the extensive information required for most medical writing projects, and, as you know, things come up during any project that require flexibility and reworking of the matrix: new data is released and has to be worked in, other data is held up in final review, a principal plans a vacation when they were scheduled to review their section, etc. Therefore, in addition to the matrix, you should also have contingency plans in place for when things go awry.
As a lead writer on a large project, you likely manage multiple writers and also interface with a principal contact on the stakeholder side, or, in some cases, the stakeholders themselves. Having the ability to communicate effectively with both is a valued skill.
Communications with stakeholder representatives should be kept to a minimum. Unless there is an urgent issue that will substantially affect sensitive project timelines, batch any news or concerns into periodic updates. Sensitive issues should be handled over the phone.
Within your own team, clear, detailed communication is key for keeping the project running smoothly. Create an internal email group or chat platform for each project so that those writers are privy to all project-related correspondence.
For communications with both stakeholders and internal writing teams, taking the time to generate a file of email templates prepared for various scenarios will streamline your communication process and ensure key questions/points aren’t inadvertently left out in the heat of the moment. Make the email subject lines very clear and don’t be afraid to call out that an RSVP is required urgently. To make the body of the email skimmable, write a short summary of what the email requires and use bullet points and bold text to highlight key points.
Finally, don’t be afraid to pick up the phone. Sometimes a quick call can subvert a lengthy email exchange.
There are two ways to manage changes and updates to large medical regulatory documents: use/update one dedicated document and reconcile changes manually or via the application’s automated tools; or, use a secure, cloud-based application that allows changes from multiple sources in real time. Either way, sufficient time must be spent ensuring all changes were made correctly, and also that the changes did not upset the document’s formatting. When reviewing changes to a section using a tracking feature, be sure and do a final review of the section with all the highlights turned off to make sure the formatting hasn’t shifted, and verify that the sentence structure is in tact.
One of the lead writer’s lesser-known skills is new writer training.Certainly, you don’t have substantial time to sit down with each new writer as they come on board and walk them through basic SOPs. A database of graduated training materials can get new writers up to speed on company processes, style-sheets, use of document templates, and other standard procedures. That leaves more time for you to give new writers valuable feedback and answer specific questions as they are introduced to new projects.
Proofing and fact checking a near 300-page document can be arduous, and, in fact, most lead writers report spending a large percentage of their time on the task. While there’s no real way to speed up a read-through of the entire document, checking the document against a predetermined style sheet can make locating errors in naming conventions, broken formatting, and missed template fields much quicker. Using the “Find” command for red-flagged terms and template <<field>> terms can help you catch many things before you even begin the proofing process. A style sheet can also call out known areas of concern so that writers can review those sections more effectively.
While this process can be time consuming, it reflects well on your company’s reputation to submit documents for stakeholder review with these errors resolved.
The best time to identify holes in your workflow is right after a project is completed. Budget in the time for a sit down (or web conference) with your principal and your writers and download all that went right or wrong with the project. This may seem redundant, but it is a step that will inform the schedules/planning of future projects and also help you build contingencies based on real scenarios while they are still fresh.
Criterion Edge (CE) employs top talent in the regulatory business to deliver high quality medical/regulatory writing and clinical safety services to the pharmaceutical and medical device industries. Members of the CE team enjoy support from our project managers, support staff, and ongoing training programs to keep them up-to-date on the latest regulatory guidelines. Interested in being a part of our team? Check out our current openings.
View Criterion Edge’s President, Laurie Mitchell, and Evidence Partners’ President, Peter O’Blenis, for an xTalks webinar on State of the Art Literature Review: How To Get It Right. (recorded: December 11, 2018, 9 AM PST/12pm EST)
Tune in to learn about key components of an effective state of the art description as well as common points of failure in state of the art literature reviews. Peter and Laurie will expand on sound methods and expert tips for completing an effective literature search. They will be covering the best practices to efficiently produce and maintain a fully compliant and audit-ready clinical background/state of the art description using DistillerSR, and addressing any questions or concerns that may arise.
Join Criterion Edge’s VP of Scientific and Medical Affairs, Kyoko Hattori for an informational webinar on Endpoint Adjudication by the Clinical Endpoints Committee.
Date/Time: September 12th, 2018 at 11 AM PST/2 PM EST
Kyoko brings over 30 years of expertise to share with clinical field scientists and managers, drug safety specialists, medical monitors, and more. Join Kyoko and other senior professionals during the webinar to learn more about familiarization and guidance using endpoint adjudication by the CEC. (more…)
There is no doubt that establishing state of the art is a challenge. It ranges from key information on the medical condition to a neutral, comprehensive analysis of treatment options, and culminates in a succinct yet comprehensive presentation that defines the currently accepted safety and performance standards against which the device is measured. Not surprisingly, common pitfalls include a perspective that is too broad and inclusion of too much detail, or a perspective that is too narrow, omitting relevant indications and alternative therapeutic options. An important critical aspect of the clinical evaluation that relies on state of the art data is also to appropriately define the position of the device within the currently available treatment portfolio.
June 17-21, 2019
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