Writing Effective Development Reports - How to Document a Scientific Process - BioPharm International


Writing Effective Development Reports
How to Document a Scientific Process

BioPharm International

Tool #1: The Outline

Table 2. Outline template for development report
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.

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. Types of templates for reports
Table 3 lists templates that are often used for development 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.

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