Writing and Publishing the Trial Protocol


January 27, 2016

We’re working on this section. For now, have a look at: There is a tool to help with writing trial protocols but it is now old. Vanderbilt (which wasn’t involved in its development) have a version online.

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Top 5 Writing and Publishing the Trial Protocol Tips


It is good practice (and a good discipline) to make your protocol publicly available, preferably before the trial report comes out.


The SPIRIT 2013 guidance lists the items that should be in a trial protocol.


More to come: keep checking the site…


More to come: keep checking the site…


More to come: keep checking the site…

More About Writing and Publishing the Trial Protocol

All trials require a protocol; once the trial begins staff can use it as a sort of manual, which should contain the key information for the trial to be completed. There are multiple guidelines for writing a trial protocol although the end results are similar: you basically need to say what you are going to do, why, when, where, how and with whom.  Publishing protocols is mandatory to all intents and purposes so it’s important to check specific details with journals for their preferred format. In some cases journals will require a protocol to be published before they consider publishing future work resulting from trial completion. Whether the protocol is for proposed or on going trials, the publication of protocols helps to improve the standard of medical research; avoiding duplication and research waste.

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