pharmaverseraw

Raw data for domains in the pharmaversesdtm package

• Purpose
• Installation
• Data Sources
• Naming Conventions
• How To Update

Purpose {#purpose}

To provide raw datasets which can be used to generate SDTM datsets in the pharmaversesdtm package. The raw dataset does not align with any EDC (Electronic Data Capture) systems, meaning that are EDC agnostic. The raw datasets are also data standards agnostic, meaning some of the raw datasets are in CDASH (Clinical Data Acquisition Standards Harmonization) and some are not in CDASH format. We have created such examples to showcase the edc and standards agnostic features of sdtm.oak. The annotated case report forms corresponding to the raw datasets are also present in the inst\acrf folder.

Installation {#installation}

The package is available from CRAN and can be installed by running install.packages("pharmaverseraw"). To install the latest development version of the package directly from GitHub use the following code:

if (!requireNamespace("remotes", quietly = TRUE)) {
  install.packages("remotes")
}

remotes::install_github("pharmaverse/pharmaverseraw", ref = "main") # This command installs the latest development version directly from GitHub.

Data Sources {#data-sources}

Raw datasets are created based upon the SDTM domains in pharmaversesdtm package.

Naming Conventions {#naming}

Datasets are named following the associated SDTM domain names with a "_raw" appended. For example, the raw data used to create subject disposition DS domain is named as "ds_raw".

How To Update {#how-to-update}

Firstly, make a GitHub issue in {pharmaverseraw} with the planned updates. Then there are two main ways to extend the test data: either by adding new datasets or extending existing datasets with new records/variables. Whichever method you choose, it is worth noting the following:

• Programs that generate raw data are stored in the data-raw/ folder.
• Each of these programs is written as a standalone R script: if any packages need to be loaded for a given program, then call library() at the start of the program (but please do not call library(pharmaverseraw)).
• When you have created a program in the data-raw/ folder, you need to run it as a standalone R script, in order to generate a raw dataset that will become part of the {pharmaverseraw} package, but you do not need to build the package.
• Following best practice, each dataset is stored as a .rda file whose name is consistent with the name of the dataset, e.g., dataset xx_raw is stored as xx_raw.rda. The easiest way to achieve this is to use usethis::use_data(xx_raw)
• The programs in data-raw/ are stored within the {pharmaverseraw} GitHub repository, but they are not part of the {pharmaverseraw} package--the data-raw/ folder is specified in .Rbuildignore.
• When you run a program that is in the data-raw/ folder, you generate a dataset that is written to the data/ folder, which will become part of the {pharmaverseraw} package.
• The names and sources of raw datasets are specified in R/*.R, for the purpose of generating documentation in the man/ folder.
• The generated raw datasets should adhere with the structure and content in the corresponding sdtm domain in pharmaversesdtm package.

Adding New Raw Datasets

• Create a program in the data-raw/ folder, named <name>.R, where <name> should follow the naming convention, to generate the raw data and output <name>.rda to the data/ folder.
  • Note that no personal data should be used as part of this package, even if anonymized.
• Run the program.
• Reflect this update by documenting the dataset in the R/*.R file.
• Run devtools::document() in order to update NAMESPACE and update the .Rd files in man/.
• Add your GitHub handle to .github/CODEOWNERS.
• Update NEWS.md.

Updating Existing SDTM Datasets

• Locate the existing program <name>.R in the data-raw/ folder, update it accordingly.
• Reflect this update by updating the corresponding script in the R/*.R file.
• Run the program, and output updated <name>.rda to the data/ folder.
• Run devtools::document() in order to update NAMESPACE and update the .Rd files in man/.
• Add your GitHub handle to .github/CODEOWNERS.
• Update NEWS.md.