Writing Effective Development Reports

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.

Why Write Development Reports?

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:

• accurately record what was known during development, and when

• document the science behind a patent application and provide technical review; to aid in preparation of the patent application

• prevent reinvention or repeat experimentation by documenting results in a central file

• summarize experiments and provide interpretations in support of patents, regulatory filings, and product claims

• meet regulatory requirements of recording a process history and history of change, with rationale

• ensure that material submitted for external publication is widely available internally, and captured in a filing system

Writing reports can also provide added perspective, stimulate new interpretations, and help an employee achieve a promotion or other career goal.

Quick Recap

How to Make Writing Easier

Many activities compete for time and attention in the typical biopharmaceutical firm. You can encourage interest in writing by making sure scientists:

• recognize writing as part of their job

• understand company expectations for quality, quantity, style, and time frames

• understand deadlines, and know there will be consequences for not meeting them

• receive training

• do not procrastinate, which can lead to decreased standards as deadlines approach

First, Align the Team

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:

• Why are we writing these reports?

• What barriers and obstacles are in the way for authors? For reviewers?

• How can reviewers make it easier for authors?

• How can authors make it easier for reviewers?

Often, a simple list of ground rules can be generated and agreed upon, such as establishing deadlines and managing expectations

Tools of the Trade

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

Tool #1: The Outline

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

Tool #2: Templates and examples of reports

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

Tool #3: Boilerplate text

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.

Tool #4: Differentiate the Types of Reviews

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:

• High-level technical reviews. Reviewers, usually managers or supervisors, check for thoroughness of content and make sure there is enough information to support the conclusions. This type of review is usually left until last, to give the author as much time as possible to write and edit.

• Data review. At some point, all data, calculations, and manipulations should be reviewed by a second person to check for errors. At the same time, the traceability of the data—the ability to trace back from the report to the original raw data in laboratory notebooks, records, or computerized data records—can be checked. A requirement of cGMP, this step is important even for early research data, if important decisions and claims will be based on the data. Once data have been reviewed, they should be placed in a format protected from accidental loss or change, such as a .pdf instead of a spread sheet.

• Technical review. The entire report must be reviewed to ensure that conclusions are supported by the data, appropriate earlier work is cited, and science is sound. The reviewer should also ensure that statistical tools used are appropriate, that all assumptions appear to be scientifically valid, and that experimental controls are complete and adequate. The reviewer should ask, "Did it work? Are the conclusions believable?"

• Copy editing. The reviewer should check grammar, spelling, and punctuation for correctness, and check for clarity and readability. A copy editor asks the author to explain ambiguous passages and may suggest simplifying sentences or changing the order of sentences to facilitate reader comprehension.

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.

• Proofing. In the final step before publishing, spelling, numbering and cross-references are checked for errors. Usually, this step involves the author and a document specialist.

Conclusion

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