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Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.
Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.
Many scientists are expected to write and review development reports, but do not understand their purpose, and give these tasks low priority. Reports are necessary to:
Writing reports can also provide added perspective, stimulate new interpretations, and help an employee achieve a promotion or other career goal.
Quick Recap
Many activities compete for time and attention in the typical biopharmaceutical firm. You can encourage interest in writing by making sure scientists:
The single most important action you can take to facilitate writing is to assemble the team of authors (and reviewers) and talk about challenges, problems, and potential solutions. Ask the following questions:
Often, a simple list of ground rules can be generated and agreed upon, such as establishing deadlines and managing expectations
Writers and reviewers should be trained and provided the tools of the trade. Training can be done individually or in groups.
Table 1. Typical gripes about reports
Your English teacher was correct: outlines help when writing a report. Table 2 shows an example of a template that can help an author begin to draft a new report. Many writers have said that the template has helped them to begin and to identify gaps or questions. The template also provides, at the start, a documented agreement with reviewers. One author commented that it was a big step forward simply to know who would be doing the review before the writing began.
Table 2. Outline template for development report
Do your scientists prefer templates, which they use in every report, or new structures for each different document? Often, scientists want both. A template is fine if it works for the author and is not overly restrictive.
Anyone who has pasted together a document from parts contributed by several authors understands the frustration and time involved in reformatting. Templates can help to minimize unnecessary confusion. The template not only looks more professional, it assists in the review process. All stakeholders become accustomed to the template and know where to look for particular information. It may be a good idea to start with a very simple template, and offer more complex templates later on. The authors should have input into template design.
If your firm does not have templates, you could use an existing report as an example and ask authors to follow its style, length, and formatting. As more reports are created, the example can be updated.
Table 3 lists templates that are often used for development reports.
Table 3. Types of templates for reports
Boilerplate text is generic information that can be pasted into any document and used repeatedly. These texts, which do not need to be re-edited each time they are used, promote consistency and uniformity and provide the author with ready-to-use material. Boilerplate text can be preloaded into templates and used or deleted, as appropriate.
Although biopharmaceutical companies sometimes offer writing instruction, they rarely offer instruction for reviewers. Omitting training for reviewers places a heavier burden on the author, who must reconcile conflicting feedback and finish the report on time. Training can be conducted in individual or group settings, for a specific report, or a group of papers. Different types of articles require different types of reviews. For example:
Most reviewers begin to copy edit the article from the start but this may result in well-worded descriptions of experiments that should not be included in the report. Copy editing is the one type of review that can most easily outsourced. Copy editors are much less costly than scientists, and can greatly improve the quality of written output without slowing it down. Scientists who publish in journals will be familiar with this step, which occurs after their manuscript is reviewed and accepted for publication.
Defining the steps, ground rules, and roles and responsibilities of report-writing helps to achieve high-quality documents. Try to minimize the number of times a report is sent back to the author for rewriting. Also be sure to reduce surprises by discussing reports at the outline stage. This will ease the frustration writers and reviewers frequently feel and will help get reports out on time, and of high enough quality to show the US Food and Drug Administration—or your joint venture partner.
PAULA J. SHADLE, PhD, is principal consultant with Shadle Consulting, 501 McBride Drive, Lafayette, CA 94549; 925.878.5130; SHAD1357@AOL.COM