2. Developing and writing protocols
How to write and publish a study protocol: overview
➔ Understand different meanings of the term “protocol”
➔ Communicate the value of planned research
➔ Appreciate the characteristics of a good research question
➔ Match research questions to appropriate study designs
➔ Identify strengths and weaknesses of published protocols.
Clinical trial protocols: how to write and publish them
➔ Understand the importance and limitations of trial registration
➔ Choose the correct guideline for writing a protocol paper
➔ Understand the key features of ICH GCP E6 and SPIRIT guidelines for reporting clinical trial protocols
➔ Prepare a real clinical trial protocol for publication in a journal.
How to write a research protocol for a grant application
➔ Understand when a research grant is needed
➔ Know how to prepare a grant application
➔ Understand the principles of grant review
➔ Appreciate why a research plan for funding must be based on a high quality study protocol
➔ Use simple language when writing the research plan.
Good medical writing
➔ How to tell the story of the study using IMRaD format
➔ How to use structure, style, and language to write well
➔ Writing in an evidence based style
➔ “House style” at journals
➔ Templates to facilitate writing and submission
➔ When and how to use medical writing and translation services.
Choosing and citing references
➔ Search published literature for appropriate references
➔ Pick and read relevant references to support key statements
➔ Cite accurately and fully, avoiding plagiarism
➔ Beware of web references
➔ Ignore or contest journal requests for “self-citation”
➔ Follow journal advice, using Vancouver or Harvard style.