Regulatory issues Learning outcomes: ➔ Define regulations that apply to clinical trials ➔ Describe good clinical practice. How to write up industry-sponsored trials Learning outcomes: ➔ The evidence on misreporting of industry trials ➔ Potential pitfalls of using composite end points in trials ➔ Reporting of authorship for industry studies ➔ How to report industry trials transparently ➔ Good publication practice (GPP3) for industry studies.
Submitting research to a journal and achieving publication
Navigating journal and peer review processes Learning outcomes: ➔ Key points to consider when choosing a journal ➔ Tips on choosing between local, and national, and international journals ➔ What the term “indexed journal” means ➔ Measures of impact, particularly journal impact factor
➔ Publishing with open access ➔ Typical peer review process
➔ How journals try to minimise bias in peer review ➔ Research evidence for different kinds of peer review ➔ How to avoid predatory journals.
Compliance with journal and ICMJE requirements Learning outcomes: ➔ Why journals vary widely and have different editorial policies ➔ Core requirements for all medical journals
➔ The Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals from the International Committee of Medical Journal Editors (ICMJE) ➔ Importance of key ICMJE policies (on authorship, conflicts of interest, clinical trial transparency) ➔ Overview of the authorship rules and the role of the corresponding author ➔ The rules on clinical trial registration ➔ Examples of specific journal policies eg The BMJ’s patient review of research.
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