Project Management: the Investigator's Brochure as a Case Study

Because medical writers do their work at the end of a long chain of team responsibilities, they must learn project management skills if they are to succeed and meet their deadlines. Here we will use the preparation of a typical "complex" document, the Investigator's Brochure, as a case study in how to manage a project as a medical writer. In the first part, participants will learn the "theory" of IB writing, i.e. what the ICH and regulatory guidelines say, as well as tools to be used in successful IB writing gleaned from the extensive experience of the workshop leader. In the second part, participants will work in groups to prepare an IB outline based on actual data and compare their results to those of other groups.


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