How Do People at FDA Read Documents On-Screen?

With the substantial move to submitting electronic documents versus paper documents to FDA, it is useful to pause and consider how a regulatory reviewer actually reads a large complex technical document on screen.

Cuppan, Gregory P. Brainery.net (2009). Articles>Scientific Communication>Regulatory Writing>Biomedical

Markers That Help Measure Communication Quality

In our consultancy, we have developed a set of terms that represent what we consider to be an effective set of descriptive markers. Markers that help to measure how well a document is communicating. We characterize our set of markers as “Document Standards” for all forms of technical and scientific writing.

Cuppan, Gregory P. Brainery.net (2009). Articles>Documentation>Quality>Standards

How Do You Measure Communication Quality?

Most people involved with authoring and reviewing process do not have good markers to inform them of the overall communication quality of a document. So without good markers they are left to utilize really poor markers to help them measure document quality.

Cuppan, Gregory P. Brainery.net (2009). Articles>Documentation>Quality>Standards

Musings: What do you Mean Knowledge Management and Negotiating Meaning in Technical and Scientific Reports

"Meaning must be negotiated and confirmed." This is an important concept not just for developing a working definition for a term like knowledge management, but it is also an approach critical to the conveyance of knowledge in scientific and technical report.

Cuppan, Gregory P. Brainery.net (2009). Articles>Knowledge Management>Scientific Communication

Improving the Practice of Document Review

Document reviews should be used as a tool to build quality into research and technical reports. In most handbooks for professional writers, review is recommended for clear and simple reasons: it is intended to identify problems and suggest improvements that enable an organization to produce documents that accomplish its goals and meet readers’ needs.

Cuppan, Gregory P. Brainery.net (2009). Articles>Documentation>Quality>Assessment

What You Need to Know to Create High Quality Electronic Documents

Submitting regulatory documents electronically to the FDA is beneficial for sponsors and regulatory reviewers, but the use of electronic submissions brings with it a set of problems associated with how these documents are read by reviewers.

Cuppan, Gregory P. Brainery.net (2009). Articles>Usability>Regulatory Writing>Biomedical

What’s Wrong with PowerPoint as a Document Authoring Tool?

It is our position that use of PowerPoint for document planning negatively impacts all potential collaborative authoring and review outcomes. Though PowerPoint is commonly used because it is a familiar tool, it is not the most effective tool for managing knowledge either intellectually or financially.

Cuppan, Gregory P. Brainery.net (2009). Articles>Project Management>Technical Writing>Microsoft PowerPoint

What Reviewers Need to Know About the Regulatory Reader, Continued

One of the big problems in document review is that reviewers often fail to recognize that their principal job as a reviewer is to act as a surrogate for the document end-user, in this case the regulatory reader. In this article, we offer a characterization of the reading style of the regulatory reader which is useful to keep in mind when reviewing any document or group of documents to be submitted to pharmaceutical and medical device regulatory agencies.

Cuppan, Gregory P. Brainery.net (2009). Articles>Scientific Communication>Regulatory Writing

Why Is It That Teams Do A Poor Job of Post-Writing-Project Analysis?

Project teams may recognize that reviews are not working well, though the may not understand why. A valuable solution is to conduct ”lessons learned” analysis following the end of the project. Too often, though, post-writing-project analysis receives little commitment or meaningful effort, but why?

Cuppan, Gregory P. Brainery.net (2009). Articles>Documentation>Collaboration>Assessment