2. Developing and writing protocols

Important elements of study protocols

Learning outcomes:
➔ Understand the reasons for writing a study protocol
➔ Match research questions to appropriate research designs
➔ Identify the core elements of the study protocol
➔ Understand the information that needs to be included in each section of the study protocol

Publishing study protocols

Learning outcomes:
➔ Understand the reasons for publishing study protocols
➔ Identify the difference between study protocols and published protocols
➔ Understand some of the publishers’ requirements for publishing protocols

Clinical trial protocols: how to write and publish them

Learning outcomes:
➔ Understand the importance and limitations of trial registration
➔ Choose the correct guideline for writing a study protocol for a clinical trial
➔ 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

Learning outcomes:
➔ 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
➔ Understand the principles of writing plain English summaries for research funding applications

Good medical writing

Learning outcomes:
➔ Know how to tell the story of the study using IMRaD format
➔ Understand how to use structure, style, and language to write well
➔ Understand writing in an evidence-based style
➔ Know what is meant by “house style” at journals
➔ Know how to use templates to facilitate writing and submission
➔ Understand the guidelines regarding the use of artificial intelligence in academic writing, and the use of professional medical writing services and translation services

Choosing and citing references

Learning outcomes:
➔ Know how to search published literature for appropriate references
➔ Know how to pick and read relevant references to support key statements
➔ Be able to cite accurately and fully, avoiding plagiarism
➔ Know to beware of web references
➔ Know how to ignore or contest journal requests for “self citation”
➔ Be able to follow journal advice, using Vancouver or Harvard style

Those who successfully complete this course can receive a 75% discount on article processing charges for protocols submitted to BMJ Open.