flowchart TD
gsm["<b>gsm</b><br/><i>deprecated Mar 2025</i>"]:::deprecated
gsm --> core["<b>gsm.core</b><br/>analytics engine"]
gsm --> workr["<b>workr</b><br/>workflow runtime"]
gsm --> mapping["<b>gsm.mapping</b><br/>data transformation"]
gsm --> kri["<b>gsm.kri</b><br/>metrics & visualization"]
gsm --> reporting["<b>gsm.reporting</b><br/>reporting data model"]
classDef deprecated fill:#dc3545,stroke:#a71d2a,color:#fff;
Packages
Overview
The OpenRBQM framework is designed to provide a robust and flexible solution for risk-based quality management. It includes a variety of packages that help streamline processes and ensure compliance with industry standards.
The {gsm} Ecosystem
The {gsm.core} package is a successor to {gsm}, which was deprecated in March 2025. The contents of {gsm} were split into a family of focused packages, each owning one part of the risk-based monitoring workflow.
Package lineage
How the packages fit together
Together the successor packages form a pipeline that turns raw clinical data into monitoring reports. {workr} executes the YAML-defined workflows that drive each step, and {gsm.core} provides the analytics used to construct and evaluate the metrics.
flowchart LR
raw[("Raw / source<br/>datasets")] --> mapping["gsm.mapping<br/><i>map to domains</i>"]
mapping --> kri["gsm.kri<br/><i>generate & visualize metrics</i>"]
kri --> reporting["gsm.reporting<br/><i>reporting data model</i>"]
reporting --> reports[["Reports"]]
core["gsm.core<br/><i>analytics engine</i>"] -. "metric analytics" .-> kri
workr["workr<br/><i>workflow runtime</i>"] -. "executes workflows" .-> mapping
workr -.-> kri
workr -.-> reporting
classDef runtime fill:#0d6efd,stroke:#0a58ca,color:#fff;
class workr,core runtime;
Package roles
| Package | Role |
|---|---|
{gsm.core} |
Analytics functionality used to construct and evaluate metrics. |
{workr} |
Workflow runtime that executes YAML-defined steps and workflows. |
{gsm.mapping} |
Workflows that transform raw/source datasets into the appropriate domains. |
{gsm.kri} |
Workflows to generate metrics, plus functionality to visualize and report on them. |
{gsm.reporting} |
Workflows to build the reporting data model needed to generate reports. |
Packages
Core Packages
gsm.core
Moved to Gilead-Public/gsm.core — this repo only hosts a docs redirect
gsm.mapping
Moved to Gilead-Public/gsm.mapping — this repo only hosts a docs redirect
gsm.mapping
Data mapping framework for {gsm}
gsm.kri
Moved to Gilead-Public/gsm.kri — this repo only hosts a docs redirect
gsm.reporting
Moved to Gilead-Public/gsm.reporting — this repo only hosts a docs redirect
gsm.reporting
Provides workflows to generate the reporting data model needed to generate reports.
Extensions and Data
gsm.datasim
Generates synthetic test data for the RBQM of Clinical Trials based on several parameters.
gsm.studykri
Bootstraps study-level KRI confidence intervals to compare a study’s KRIs against a fixed expectation or against one or more reference studies.
gsm.simaerep
gsm extension to use simaerep
gsm.simaerep.viz
JavaScript visualization library for simaerep clinical trial monitoring data, used as an htmlwidget dependency by gsm.simaerep.