Template for Clinical Trial Protocol

Contains an R Markdown template for a clinical trial protocol adhering to the SPIRIT statement. The SPIRIT (Standard Protocol Items for Interventional Trials) statement outlines recommendations for a minimum set of elements to be addressed in a clinical trial protocol. Also contains functions to create a xml document from the template and upload it to clinicaltrials.gov< https://www.clinicaltrials.gov/> for trial registration.

spiritR

This package contains an Rmarkdown template for a clinical trial protocol adhering to the SPIRIT checklist. This package was inspired by the Spirit Electronic Protocol Tool & Resource SEPTRE software program.

Contained within the template is a section for each of the elements that should be adressed in a clinical trial protocol. Links to the SPIRIT statement guidance about what should be addressed in each element are provided.

Functions in this package provide the functionality to upload information from the protocol developed in your Rmardown file to a new record in the clinicaltrials.gov registry.

Installing the package

install.packages("spiritR")

# For devel version
devtools::install_github("awconway/spiritR")

Once installed, the template will be available within the RStudio IDE by selecing 'New File' > 'R Markdown' > 'From Template'.