SDTM Test Data for the 'Pharmaverse' Family of Packages

A set of Study Data Tabulation Model (SDTM) datasets from the Clinical Data Interchange Standards Consortium (CDISC) pilot project used for testing and developing Analysis Data Model (ADaM) datasets inside the pharmaverse family of packages. SDTM dataset specifications are described in the CDISC SDTM implementation guide, accessible by creating a free account on < https://www.cdisc.org/>.

pharmaversesdtm

^{Interactive data exploration: Preview SDTM vignette}

Test data (SDTM) for the pharmaverse family of packages

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

Purpose {#purpose}

To provide a one-stop-shop for SDTM test data in the pharmaverse family of packages. This includes datasets that are therapeutic area (TA)-agnostic (DM, VS, EG, etc.) as well TA-specific ones (RS, TR, OE, etc.).

Installation {#installation}

The package is available from CRAN and can be installed by running install.packages("pharmaversesdtm"). 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/pharmaversesdtm", ref = "main") # This command installs the latest development version directly from GitHub.

Data {#data}

Data Sources

Some test datasets have been sourced from the CDISC pilot project, while other datasets have been constructed ad-hoc by the {admiral} team. Please check the Reference page for detailed information regarding the source of specific datasets.

Data Formats

Each dataset is provided in both RDA and CSV formats. The .rda files are used within the R package and saved in the data folder, while the .csv files are saved in the inst/extdata/ folder.

Naming Conventions {#naming}

• Datasets that are TA-agnostic: same as SDTM domain name (e.g., dm, rs).
• Datasets that are TA-specific: domain_TA_others, others go from broader categories to more specific ones (e.g., oe_ophtha, rs_onco, rs_onco_irecist).

Note: If an SDTM domain is used by multiple TAs, {pharmaversesdtm} may provide multiple versions of the corresponding test dataset. For instance, the package contains ex and ex_ophtha as the latter contains ophthalmology-specific variables such as EXLAT and EXLOC, and EXROUTE is exchanged for a plausible ophthalmology value.

How To Update {#how-to-update}

Firstly, make a GitHub issue in {pharmaversesdtm} with the planned updates and tag @pharmaverse/admiral so that one of the development core team can sanity check the request. 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 test 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(pharmaversesdtm)).
• 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 test dataset that will become part of the {pharmaversesdtm} 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 is stored as xx.rda. The easiest way to achieve this is to use usethis::use_data(xx)
• The programs in data-raw/ are stored within the {pharmaversesdtm} GitHub repository, but they are not part of the {pharmaversesdtm} 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 {pharmaversesdtm} package.
• The names and sources of test datasets are specified in R/*.R, for the purpose of generating documentation in the man/ folder.

Note: The documentation process in {pharmaversesdtm} is automated for consistency and ease of maintenance.

Centralized Metadata (inst/extdata/sdtms-specs.json)

{pharmaversesdtm} uses a single JSON file to store metadata for all SDTM datasets. This file contains information such as:

• dataset name
• dataset label
• dataset description
• author
• source
• therapeutic area
• any other dataset-specific metadata.

This metadata drives the automated documentation process, and the file is read by data-raw/create_sdtms_data.R to help generate:

• Documentation .R files in R/
• .Rd files in man/
• Test Name/Test Code table inclusion (when present)
• Dataset grouping by Therapeutic Area.

Adding New SDTM Datasets

• Create a program in the data-raw/ folder, named <name>.R, where <name> should follow the naming convention, to generate the test data and output <name>.rda to the data/ folder, and the <name>.csv to the inst/extdata folder.
  • Use CDISC pilot data such as dm as input in this program in order to create realistic synthetic data that remains consistent with other domains (not mandatory).
  • Note that no personal data should be used as part of this package, even if anonymized.
• Run the program.
• Update inst/extdata/sdtms-specs.json with the new dataset metadata, including:
  • Assigning the dataset label, description, author, source, purpose, or structure.
  • Assigning or updating the dataset therapeutic area (used for reference-page grouping).
• Run data-raw/create_sdtms_data.R 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.
• Update the corresponding entry in inst/extdata/sdtms-specs.json to reflect the changes, including:
  • Changing the dataset label, description, author, or source.
  • Modifying the dataset purpose or structure.
  • Updating the dataset therapeutic area.
  • Removing a dataset (delete its entry from the JSON entirely).
• Run the program, and output updated <name>.rda to the data/ folder, and the <name>.csv to the inst/extdata folder.
• Run data-raw/create_sdtms_data.R in order to update NAMESPACE and update the .Rd files in man/.
• Add your GitHub handle to .github/CODEOWNERS.
• Update NEWS.md.

Acknowledgments

Along with the authors and contributors, thanks to the following people for their work on the package:

G Gayatri, Pooja Kumari, Sadchla Mascary, Kangjie Zhang and Zelos Zhu.