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Introduction

Risk-Based Quality Monitoring (RBQM) is a proactive approach to clinical trial monitoring that focuses on identifying and addressing the most critical risks to the integrity of study data and patient safety. This approach aims to ensure that study data are accurate, reliable, and credible while optimizing the use of resources and minimizing the burden on study sites.

The gsm R package supports RBQM by performing risk assessments primarily focused on detecting differences in quality at the site level. This approach is intended to detect potential issues related to critical data or process(es) across the major risk categories of safety, efficacy, disposition, treatment, and general quality. Each category consists of one or more risk assessment(s). Each risk assessment analyzes the data to flag sites with potential outliers and provides a visualization to help the user understand the issue.

Scope

Qualification testing ensures that core functions execute as expected on a system-wide scale. Qualification includes executing various functional, performance, and usability testing. Qualification tests are designed to provide developers with a repeatable process that is easy to update and document. This document summarizes the qualification testing performed on gsm functions essential to the analysis workflow.

Process Overview

Each essential gsm workflow function is independently qualified using specifications and test cases compiled in this report. Details are provided below.

Specifications

Specifications capture the most critical use cases for a given function. Each function must have at least one (1) specification, and each specification must have at least one (1) associated test case. Multiple specifications may exist for a function, and multiple test cases may exist for a specification.

Each specification includes the following components:

  • Description: outlines the use case for the specification

  • Risk Assessment

    • Risk Level: assigned a value of “Low”, “Medium”, or “High”, corresponding to the risk associated with the specification failing

    • Risk Impact: assigned a value of “Low”, “Medium”, or “High”, corresponding to the severity of the impact associated with the specification failing

  • Test Cases: lists measurable test cases associated with the specification

Test Cases

Test cases translate specifications into testable scripts to confirm that the package functions meet the established requirements. Test cases represent how a user may utilize the function to help identify code gaps and support testing automation.

Test cases for gsm are written using the standard testthat workflow. A single test script is saved for each test case and is named following the convention test_qual_{TestID}.R, where TestID is the test case number. Test code within these scripts is written clearly and concisely to facilitate quick execution and interpretability. Note that a single test case may be associated with multiple specifications.

Test Results: Overview

Function Name Number of Tests Number Passed Number Failed Number Skipped
Adverse Event Assessment 52 52 0 0
Analysis workflow 22 21 0 0
Analyze_NormalApprox_PredictBounds 19 19 0 0
Data Change Rate Assessment 19 19 0 0
Data Entry Lag Assessment 19 19 0 0
Disposition Assessment 35 35 0 0
Flag_NormalApprox 7 7 0 0
Labs Assessment 19 19 0 0
Mapping workflow 46 46 0 0
Protocol Deviation Assessment 30 30 0 0
Query Age Assessment 35 35 0 0
Query Rate Assessment 35 35 0 0
Summarize 16 16 0 0

Test Results: Detailed

One Row Per Specification

Spec ID Spec Description Risk Impact Associated Test IDs
S1_1 Given raw participant-level data, all necessary data.frame transformations are made to create input data for all workflows High High T1_1
S2_1 Given raw participant-level data, a properly specified Workflow for a KRI creates summarized and flagged data High High T2_1
S2_2 Given raw participant-level data with missingness, a properly specified Workflow for a KRI creates summarized and flagged data High High T2_2
S3_1 Given pre-processed input data, a properly specified Workflow for a KRI creates summarized and flagged data High High T3_1
S4_1 Given appropriate metadata (i.e. vThresholds), flagged observations are properly marked in summary data High High T4_1
S4_2 Given appropriate metadata (i.e. vThresholds), data.frame of bounds can be created High High T4_2
S5_1 Given appropriate raw participant-level data, flag values can be correctly assigned to records that meet flagging criteria, including custom thresholding. High High T5_1
S5_2 Given appropriate raw participant-level data, flag values are correctly assigned as NA for sites with low enrollment. High High T5_2
S6_1 Given appropriate raw participant-level data, an Adverse Event Assessment can be done using the Normal Approximation method. High High T6_1
S6_2 Adverse Event Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. High High T6_2
S7_1 Given appropriate raw participant-level data, a Protocol Deviation Assessment can be done using the Normal Approximation method. High High T7_1
S7_2 Protocol Deviation Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. High High T7_2
S8_1 Given appropriate raw participant-level data, a Dispositon Assessment can be done using the Normal Approximation method. High High T8_1
S8_2 Disposition Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. High High T8_2
S9_1 Given appropriate raw participant-level data, a Labs Assessment can be done using the Normal Approximation method. High High T9_1
S9_2 Labs Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. High High T9_2
S10_1 Given appropriate raw participant-level data, a Data Change Rate Assessment can be done using the Normal Approximation method. High High T10_1
S10_2 Data Change Rate Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. High High T10_2
S11_1 Given appropriate raw participant-level data, a Data Entry Lag Assessment can be done using the Normal Approximation method. High High T11_1
S11_2 Data Entry Lag Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. High High T11_2
S12_1 Given appropriate raw participant-level data, a Query Age Assessment can be done using the Normal Approximation method. High High T12_1
S12_2 Query Age Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. High High T12_2
S13_1 Given appropriate raw participant-level data, a Query Rate Assessment can be done using the Normal Approximation method. High High T13_1
S13_2 Query Rate Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. High High T13_2

One Row Per Test

Function Spec ID Test ID Test Description Test Result
Mapping workflow S1_1 T1_1 mappings now done by individual domain, test that inputs and outputs of priority 1 mappings are completed as expected Pass
Mapping workflow S1_1 T1_1 mappings now done by individual domain, test that inputs and outputs of priority 2 mappings are completed as expected Pass
Mapping workflow S1_1 T1_1 mappings now done by individual domain, test that inputs and outputs of priority 3 mappings are completed as expected Pass
Analysis workflow S2_1 T2_1 Given raw participant-level data, a properly specified Workflow for a KRI creates summarized and flagged data Pass
Analysis workflow S2_2 T2_2 Given raw participant-level data with missingness, a properly specified Workflow for a KRI creates summarized and flagged data Pass
Analysis workflow S3_1 T3_1 Given pre-processed input data, a properly specified Workflow for a KRI creates summarized and flagged data Pass
Flag_NormalApprox S4_1 T4_1 Given appropriate metadata (i.e. vThresholds), flagged observations are properly marked in summary data Pass
Analyze_NormalApprox_PredictBounds S4_2 T4_2 Given appropriate metadata (i.e. vThresholds), bounds are properly applied to generate flags Pass
Summarize S5_1 T5_1 Given appropriate raw participant-level data, flag values can be correctly assigned to records that meet flagging criteria, including custom thresholding. Pass
Summarize S5_2 T5_2 Given appropriate raw participant-level data, flag values are correctly assigned as NA for sites with low enrollment. Pass
Adverse Event Assessment S6_1 T6_1 Given appropriate raw participant-level data, an Adverse Event Assessment can be done using the Normal Approximation method. Pass
Adverse Event Assessment S6_2 T6_2 Adverse Event Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. Pass
Protocol Deviation Assessment S7_1 T7_1 Given appropriate raw participant-level data, a Protocol Deviation Assessment can be done using the Normal Approximation method. Pass
Protocol Deviation Assessment S7_2 T7_2 Protocol Deviation Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. Pass
Disposition Assessment S8_1 T8_1 Given appropriate raw participant-level data, a Dispositon Assessment can be done using the Normal Approximation method. Pass
Disposition Assessment S8_2 T8_2 Disposition Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. Pass
Labs Assessment S9_1 T9_1 Given appropriate raw participant-level data, a Labs Assessment can be done using the Normal Approximation method. Pass
Labs Assessment S9_2 T9_2 Labs Assessments can be done correctly using a grouping variable, such as Site or Country for KRIs, and Study for QTLs, when applicable. Pass
Data Change Rate Assessment S10_1 T10_1 Given appropriate raw participant-level data, a Data Change Rate Assessment can be done using the Normal Approximation method. Pass
Data Change Rate Assessment S10_2 T10_2 Data Change Rate Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. Pass
Data Entry Lag Assessment S11_1 T11_1 Given appropriate raw participant-level data, a Data Entry Lag Assessment can be done using the Normal Approximation method. Pass
Data Entry Lag Assessment S11_2 T11_2 Data Entry Lag Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. Pass
Query Age Assessment S12_1 T12_1 Given appropriate raw participant-level data, a Query Age Assessment can be done using the Normal Approximation method. Pass
Query Age Assessment S12_2 T12_2 Query Age Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. Pass
Query Rate Assessment S13_1 T13_1 Given appropriate raw participant-level data, a Query Rate Assessment can be done using the Normal Approximation method. Pass
Query Rate Assessment S13_2 T13_2 Query Rate Assessments can be done correctly using a grouping variable, such as Site, Country, or Study, when applicable. Pass

Unit Tests

Unit Testing Overview

Unit testing was performed in addition to qualification testing to help ensure that individual pieces of code within the R package function correctly and produce the expected results. By testing individual units of code in isolation, developers can identify and fix issues early in the development process before more significant and scaled problems arise.

Unit Test Coverage

The table below summarizes unit test coverage of each gsm function. This metric quantifies the extent of unit testing. The closer this measure is to 100%, the more unit testing that function has.

Function File Coverage
R/aaa-shared.R 0.00 %
R/Analyze_Fisher.R 100.00 %
R/Analyze_Identity.R 100.00 %
R/Analyze_NormalApprox_PredictBounds.R 100.00 %
R/Analyze_NormalApprox.R 100.00 %
R/Analyze_Poisson_PredictBounds.R 98.21 %
R/Analyze_Poisson.R 100.00 %
R/data-specs.R 0.00 %
R/Flag.R 100.00 %
R/Input_Rate.R 88.46 %
R/Report_FlagOverTime.R 100.00 %
R/Report_FormatFlag.R 100.00 %
R/Report_KRI.R 0.00 %
R/Report_MetricCharts.R 97.44 %
R/Report_MetricTable.R 100.00 %
R/Report_OverviewText.R 100.00 %
R/Report_Setup.R 84.44 %
R/Report_StudyInfo.R 100.00 %
R/RunQuery.R 86.25 %
R/RunStep.R 81.67 %
R/RunWorkflow.R 95.28 %
R/RunWorkflows.R 100.00 %
R/Summarize.R 100.00 %
R/Transform_Count.R 100.00 %
R/Transform_Rate.R 100.00 %
R/util-ApplySpec.R 74.36 %
R/util-BindResults.R 100.00 %
R/util-CalculatePercentage.R 50.00 %
R/util-checkSpec.R 100.00 %
R/util-cli_logger_wrappers.R 18.75 %
R/util-clindata.R 66.67 %
R/util-CombineSpecs.R 96.30 %
R/util-func-namespace.R 87.50 %
R/util-gt.R 75.00 %
R/util-Ingest.R 100.00 %
R/util-logger.R 0.00 %
R/util-MakeBounds.R 84.91 %
R/util-MakeCharts.R 100.00 %
R/util-MakeLongMeta.R 100.00 %
R/util-MakeMetric.R 100.00 %
R/util-MakeMetricTable.R 100.00 %
R/util-MakeParamLabels.R 100.00 %
R/util-MakeStudyInfo.R 100.00 %
R/util-MakeWideGroups.R 100.00 %
R/util-MakeWorkflowList.R 90.16 %
R/util-ParseThreshold.R 100.00 %
R/util-RenderRmd.R 0.00 %
R/util-Report.R 89.36 %
R/Visualize_Metric.R 82.98 %
R/Visualize_Scatter.R 100.00 %
R/Visualize_Score.R 94.74 %
R/Widget_BarChart.R 78.26 %
R/Widget_FlagOverTime.R 57.78 %
R/Widget_GroupOverview.R 84.44 %
R/Widget_ScatterPlot.R 80.00 %
R/Widget_TimeSeries.R 80.43 %
R/zzz.R 0.00 %
Total Coverage 88.40 %

Qualification Testing Environment

Session Information

R version 4.4.2 (2024-10-31)

Platform: x86_64-pc-linux-gnu

locale: LC_CTYPE=C.UTF-8, LC_NUMERIC=C, LC_TIME=C.UTF-8, LC_COLLATE=C.UTF-8, LC_MONETARY=C.UTF-8, LC_MESSAGES=C.UTF-8, LC_PAPER=C.UTF-8, LC_NAME=C, LC_ADDRESS=C, LC_TELEPHONE=C, LC_MEASUREMENT=C.UTF-8 and LC_IDENTIFICATION=C

attached base packages: tcltk, stats, graphics, grDevices, utils, datasets, methods and base

other attached packages: gsm(v.2.2.1), testthat(v.3.2.2), riskmetric(v.0.2.4), stringr(v.1.5.1), gh(v.1.4.1), pander(v.0.6.5), purrr(v.1.0.2), dplyr(v.1.1.4), knitr(v.1.49) and gt(v.0.11.1)

loaded via a namespace (and not attached): tidyselect(v.1.2.1), urltools(v.1.7.3), fastmap(v.1.2.0), lazyeval(v.0.2.2), duckdb(v.1.1.3-1), promises(v.1.3.2), rex(v.1.2.1), digest(v.0.6.37), mime(v.0.12), lifecycle(v.1.0.4), waldo(v.0.6.1), ellipsis(v.0.3.2), magrittr(v.2.0.3), compiler(v.4.4.2), rlang(v.1.1.4), sass(v.0.4.9), tools(v.4.4.2), yaml(v.2.3.10), htmlwidgets(v.1.6.4), pkgbuild(v.1.4.5), curl(v.6.0.1), here(v.1.0.1), xml2(v.1.3.6), cranlogs(v.2.1.1), pkgload(v.1.4.0), miniUI(v.0.1.1.1), covr(v.3.6.4), withr(v.3.0.2), desc(v.1.4.3), triebeard(v.0.4.1), grid(v.4.4.2), urlchecker(v.1.0.1), profvis(v.0.4.0), xtable(v.1.8-4), colorspace(v.2.1-1), log4r(v.0.4.4), ggplot2(v.3.5.1), scales(v.1.3.0), cli(v.3.6.3), rmarkdown(v.2.29), ragg(v.1.3.3), generics(v.0.1.3), remotes(v.2.5.0), rstudioapi(v.0.17.1), httr(v.1.4.7), sessioninfo(v.1.2.2), DBI(v.1.2.3), cachem(v.1.1.0), BiocManager(v.1.30.25), vctrs(v.0.6.5), devtools(v.2.4.5), jsonlite(v.1.8.9), systemfonts(v.1.1.0), tidyr(v.1.3.1), jquerylib(v.0.1.4), clindata(v.1.0.5), glue(v.1.8.0), pkgdown(v.2.1.1), stringi(v.1.8.4), gtable(v.0.3.6), later(v.1.4.1), munsell(v.0.5.1), tibble(v.3.2.1), pillar(v.1.10.0), htmltools(v.0.5.8.1), brio(v.1.1.5), R6(v.2.5.1), dbplyr(v.2.5.0), textshaping(v.0.4.1), rprojroot(v.2.0.4), evaluate(v.1.0.1), shiny(v.1.10.0), backports(v.1.5.0), memoise(v.2.0.1), broom(v.1.0.7), httpuv(v.1.6.15), bslib(v.0.8.0), Rcpp(v.1.0.13-1), xfun(v.0.49), fs(v.1.6.5), usethis(v.3.1.0) and pkgconfig(v.2.0.3)

Package List

The table below utilizes the riskmetric package, which quantifies the robustness of an R package. The pkg_score column captures the risk involved with using a package. The risk level ranges from 0 (low risk) to 1 (high risk).

package version pkg_score
broom 1.0.7 0.322
cli 3.6.3 0.396
DBI 1.2.3 0.341
dbplyr 2.5.0 0.393
dplyr 1.1.4 0.399
duckdb 1.1.3.1 0.438
ggplot2 3.5.1 0.400
glue 1.8.0 0.278
gt 0.11.1 0.452
htmltools 0.5.8.1 0.409
htmlwidgets 1.6.4 0.316
jsonlite 1.8.9 0.472
lifecycle 1.0.4 0.312
log4r 0.4.4 0.359
magrittr 2.0.3 0.288
purrr 1.0.2 0.369
rlang 1.1.4 0.414
stats 4.4.2 0.704
stringr 1.5.1 0.354
tibble 3.2.1 0.348
tidyr 1.3.1 0.360
tools 4.4.2 0.734
utils 4.4.2 0.687
yaml 2.3.10 0.429

Pull Request History

Pull Request 2009: gsm v2.2.1 release

Merging dev into main

https://github.com/Gilead-BioStats/gsm/pull/2009

Requester Date Requested Reviewers Review Status
lauramaxwell 2025-01-06 20:28:21 APPROVED

Pull Request 2008: gsm v2.2.1 release candidate

Merging gsm-v2.2.1-rc into dev

https://github.com/Gilead-BioStats/gsm/pull/2008

Requester Date Requested Reviewers Review Status
lauramaxwell 2025-01-06 18:37:29 zdz2101 APPROVED

Pull Request 2005: Add docs and tests for lConfig

Merging fix-1984 into dev

https://github.com/Gilead-BioStats/gsm/pull/2005

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-20 19:02:55 APPROVED

Pull Request 2004: add subject disposition

Merging add-disposition into dev

https://github.com/Gilead-BioStats/gsm/pull/2004

Requester Date Requested Reviewers Review Status
samussiah 2024-12-20 18:01:36 Zhongkai-Wang COMMENTED

Pull Request 1999: Fix 1946

Merging fix-1946 into dev

https://github.com/Gilead-BioStats/gsm/pull/1999

Requester Date Requested Reviewers Review Status
samussiah 2024-12-18 15:50:54 APPROVED

Pull Request 1998: Fix #1992- always return function in namespace util

Merging fix-1992 into dev

https://github.com/Gilead-BioStats/gsm/pull/1998

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-17 21:42:00 CHANGES_REQUESTED

Merging fix-1993 into dev

https://github.com/Gilead-BioStats/gsm/pull/1995

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-12 18:25:37 APPROVED

Pull Request 1994: Closes #1976 wrap all our stop-esque calls into the log4r setup

Merging fix-1976 into dev

https://github.com/Gilead-BioStats/gsm/pull/1994

Requester Date Requested Reviewers Review Status
zdz2101 2024-12-12 18:21:13 samussiah COMMENTED

Pull Request 1991: run styler on 2.2

Merging styler-v2.2 into dev

https://github.com/Gilead-BioStats/gsm/pull/1991

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-11 19:32:33 APPROVED

Pull Request 1990: GSM v2.2.0 release

Merging dev into main

https://github.com/Gilead-BioStats/gsm/pull/1990

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-11 19:08:23 APPROVED

Pull Request 1988: add namespacing capability

Merging namespacing-1987 into v2.2.0-rc

https://github.com/Gilead-BioStats/gsm/pull/1988

Requester Date Requested Reviewers Review Status
dpastoor 2024-12-11 14:11:30 COMMENTED

Merging fix-RunQuery into v2.2.0-rc

https://github.com/Gilead-BioStats/gsm/pull/1986

Requester Date Requested Reviewers Review Status
samussiah 2024-12-10 18:06:09 annezheng2 APPROVED

Pull Request 1985: V2.2.0 rc

Merging v2.2.0-rc into dev

https://github.com/Gilead-BioStats/gsm/pull/1985

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-09 20:14:41 jwildfire CHANGES_REQUESTED

Pull Request 1982: fix ldata passthrough, resolves #1981

Merging fix-1981 into dev

https://github.com/Gilead-BioStats/gsm/pull/1982

Requester Date Requested Reviewers Review Status
dpastoor 2024-12-08 15:26:24 APPROVED

Merging fix-1972 into dev

https://github.com/Gilead-BioStats/gsm/pull/1977

Requester Date Requested Reviewers Review Status
zdz2101 2024-12-05 21:48:36 COMMENTED

Pull Request 1975: Add thresholds back into barcharts

Merging fix-1958 into dev

https://github.com/Gilead-BioStats/gsm/pull/1975

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-05 20:13:11 APPROVED

Pull Request 1970: Update vignettes

Merging fix-1954 into dev

https://github.com/Gilead-BioStats/gsm/pull/1970

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-03 21:02:39 APPROVED

Pull Request 1969: Fix typo in STUDY.yaml

Merging fix-1968 into dev

https://github.com/Gilead-BioStats/gsm/pull/1969

Requester Date Requested Reviewers Review Status
jonthegeek 2024-12-03 19:29:28 APPROVED

Pull Request 1965: Closes #1964 update RunQuery to apply data types where applicable

Merging fix-1964 into dev

https://github.com/Gilead-BioStats/gsm/pull/1965

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-12-02 14:58:26 dpastoor annezheng2 COMMENTED

Pull Request 1961: Add hooks to RunWorkflow .

Merging fix-1818 into dev

https://github.com/Gilead-BioStats/gsm/pull/1961

Requester Date Requested Reviewers Review Status
samussiah 2024-11-22 22:46:13 COMMENTED

Pull Request 1960: Update query for treatment discontinuation KRIs

Merging fix-1959 into dev

https://github.com/Gilead-BioStats/gsm/pull/1960

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-22 20:14:31 APPROVED

Pull Request 1957: add fields to STUDY.yaml

Merging fix-1956 into dev

https://github.com/Gilead-BioStats/gsm/pull/1957

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-21 16:25:51 annezheng2 COMMENTED

Pull Request 1953: Closes #1937 Display only results of metrics where data is available in reports

Merging fix-1937 into dev

https://github.com/Gilead-BioStats/gsm/pull/1953

Requester Date Requested Reviewers Review Status
zdz2101 2024-11-19 20:19:46 COMMENTED

Pull Request 1951: Remove required from yamls and associated functions

Merging fix-1936 into dev

https://github.com/Gilead-BioStats/gsm/pull/1951

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-18 15:05:49 COMMENTED

Pull Request 1949: Fix table placement in qual report pdf

Merging fix-qual-report into dev

https://github.com/Gilead-BioStats/gsm/pull/1949

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-14 20:06:11 APPROVED

Pull Request 1947: Release v2.1.2

Merging dev into main

https://github.com/Gilead-BioStats/gsm/pull/1947

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-14 17:21:03 zdz2101 APPROVED

Pull Request 1945: PD > IPD and display site activation / participant enrollment in study info.

Merging fix-1918 into gsm-v2.1.2-rc

https://github.com/Gilead-BioStats/gsm/pull/1945

Requester Date Requested Reviewers Review Status
samussiah 2024-11-14 15:03:08 jwildfire COMMENTED

Pull Request 1943: Fix 1801

Merging fix-1801 into dev

https://github.com/Gilead-BioStats/gsm/pull/1943

Requester Date Requested Reviewers Review Status
annezheng2 2024-11-12 19:09:30 APPROVED

Pull Request 1942: gsm v2.1.2 release candidate

Merging gsm-v2.1.2-rc into dev

https://github.com/Gilead-BioStats/gsm/pull/1942

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-12 18:16:17 samussiah APPROVED

Pull Request 1941: Add act_fpfv and est_fpfv to STUDY.yaml spec

Merging fix-1940 into dev

https://github.com/Gilead-BioStats/gsm/pull/1941

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-12 14:16:17 APPROVED

Pull Request 1939: Closes #1933 introduces logging capabilities to gsm

Merging fix-1933 into dev

https://github.com/Gilead-BioStats/gsm/pull/1939

Requester Date Requested Reviewers Review Status
zdz2101 2024-11-08 22:08:50 samussiah COMMENTED

Pull Request 1932: Closes #1928 swaps out last remnants of kable and kableExtra in favor of gt

Merging fix-1928 into dev

https://github.com/Gilead-BioStats/gsm/pull/1932

Requester Date Requested Reviewers Review Status
zdz2101 2024-11-06 20:18:22 jonthegeek COMMENTED

Pull Request 1931: Closes #1882 adds a toggle to display past year or full data

Merging fix-1882 into dev

https://github.com/Gilead-BioStats/gsm/pull/1931

Requester Date Requested Reviewers Review Status
zdz2101 2024-11-05 18:41:05 jonthegeek COMMENTED

Pull Request 1930: Update Metrics.yaml to not generate lWorkflows within steps

Merging fix-1929 into dev

https://github.com/Gilead-BioStats/gsm/pull/1930

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-11-04 21:09:11 jwildfire COMMENTED

Pull Request 1926: Fix country metadata

Merging fix-country-metadata into dev

https://github.com/Gilead-BioStats/gsm/pull/1926

Requester Date Requested Reviewers Review Status
samussiah 2024-11-04 15:05:39 zdz2101 APPROVED

Pull Request 1923: Fix Ingest return value

Merging Ingest-docs-typo into dev

https://github.com/Gilead-BioStats/gsm/pull/1923

Requester Date Requested Reviewers Review Status
jonthegeek 2024-10-30 13:47:28 lauramaxwell APPROVED

Pull Request 1920: Refactor Flag functions

Merging fix-1911 into dev

https://github.com/Gilead-BioStats/gsm/pull/1920

Requester Date Requested Reviewers Review Status
jwildfire 2024-10-29 00:23:04 COMMENTED

Pull Request 1917: Keep bg color for switch.

Merging fix-1916 into dev

https://github.com/Gilead-BioStats/gsm/pull/1917

Requester Date Requested Reviewers Review Status
jonthegeek 2024-10-28 15:42:51 APPROVED

Pull Request 1915: Add Nickname to report header and fix RunQuery bug

Merging fix-1878 into dev

https://github.com/Gilead-BioStats/gsm/pull/1915

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-28 14:32:07 andersonjake1988 APPROVED

Pull Request 1913: updated class structure

Merging fix-1912 into dev

https://github.com/Gilead-BioStats/gsm/pull/1913

Requester Date Requested Reviewers Review Status
andersonjake1988 2024-10-25 16:34:05 APPROVED

Pull Request 1910: avoid column name conflicts between Groups and Results

Merging lock-down-groups into dev

https://github.com/Gilead-BioStats/gsm/pull/1910

Requester Date Requested Reviewers Review Status
samussiah 2024-10-24 18:00:51 APPROVED

Pull Request 1909: Release v2.1.1

Merging dev into main

https://github.com/Gilead-BioStats/gsm/pull/1909

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-23 21:25:59 APPROVED

Pull Request 1908: Fix country overview text

Merging fix-country-overview-text into dev

https://github.com/Gilead-BioStats/gsm/pull/1908

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-23 20:33:45 APPROVED

Pull Request 1907: Update rbm-viz.

Merging rbm-viz-2.1.0 into dev

https://github.com/Gilead-BioStats/gsm/pull/1907

Requester Date Requested Reviewers Review Status
jonthegeek 2024-10-23 18:47:10 APPROVED

Pull Request 1906: Embed necessary dependencies in Report_StudyInfo().

Merging fix-1905 into dev

https://github.com/Gilead-BioStats/gsm/pull/1906

Requester Date Requested Reviewers Review Status
jonthegeek 2024-10-23 17:15:14 APPROVED

Pull Request 1904: Gsm v2.1.1 release candidate

Merging gsm-v2.1.1-rc into dev

https://github.com/Gilead-BioStats/gsm/pull/1904

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-21 20:20:24 zdz2101 jwildfire APPROVED

Pull Request 1903: Fix overall group select bug.

Merging fix-1902 into dev

https://github.com/Gilead-BioStats/gsm/pull/1903

Requester Date Requested Reviewers Review Status
samussiah 2024-10-18 20:34:37 zdz2101 APPROVED

Pull Request 1901: Closes #1890 and #1900 to properly check for dates and fix other bugs in checkSpec

Merging fix-1890 into dev

https://github.com/Gilead-BioStats/gsm/pull/1901

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-18 18:10:48 zdz2101 COMMENTED

Pull Request 1899: Closes #1880 add site/participant target numbers and labels to STUDY.yaml

Merging fix-1880 into dev

https://github.com/Gilead-BioStats/gsm/pull/1899

Requester Date Requested Reviewers Review Status
zdz2101 2024-10-17 21:01:47 COMMENTED

Pull Request 1898: Flag colors

Merging fix-1896 into dev

https://github.com/Gilead-BioStats/gsm/pull/1898

Requester Date Requested Reviewers Review Status
jonthegeek 2024-10-17 15:48:50 APPROVED

Pull Request 1897: Closes #1894 address bug in Input_Rate() for 0 row dataframe inputs for dfNumerator/dfDenominator

Merging fix-1894 into dev

https://github.com/Gilead-BioStats/gsm/pull/1897

Requester Date Requested Reviewers Review Status
zdz2101 2024-10-17 15:46:12 APPROVED

Merging fix-1877 into dev

https://github.com/Gilead-BioStats/gsm/pull/1892

Requester Date Requested Reviewers Review Status
zdz2101 2024-10-15 21:01:24 samussiah COMMENTED

Pull Request 1891: Only show flag-rows in Report_FlagOverTime()

Merging fix-1879 into dev

https://github.com/Gilead-BioStats/gsm/pull/1891

Requester Date Requested Reviewers Review Status
jonthegeek 2024-10-15 15:50:40

Merging missing-data-fixes into dev

https://github.com/Gilead-BioStats/gsm/pull/1889

Requester Date Requested Reviewers Review Status
samussiah 2024-10-14 22:25:59 zdz2101 lauramaxwell APPROVED

Pull Request 1885: Make Report_StudyInfo() Friendlier to Shiny

Merging fix-1799 into dev

https://github.com/Gilead-BioStats/gsm/pull/1885

Requester Date Requested Reviewers Review Status
jonthegeek 2024-10-14 18:12:12 APPROVED

Pull Request 1884: Closes #1659 and #1660 to use gt() instead of kbl() in our functions and reports

Merging fix-1660 into dev

https://github.com/Gilead-BioStats/gsm/pull/1884

Requester Date Requested Reviewers Review Status
zdz2101 2024-10-14 16:17:13 lauramaxwell samussiah CHANGES_REQUESTED

Pull Request 1876: Fix country report

Merging fix-country-report into dev

https://github.com/Gilead-BioStats/gsm/pull/1876

Requester Date Requested Reviewers Review Status
samussiah 2024-10-10 18:31:08 lauramaxwell APPROVED

Pull Request 1875: Closes #1872 fix miscellaneous aesthetics things and issues

Merging fix-1872 into dev

https://github.com/Gilead-BioStats/gsm/pull/1875

Requester Date Requested Reviewers Review Status
zdz2101 2024-10-10 18:24:25 COMMENTED

Pull Request 1871: yes to true in yamls

Merging yaml-fix-2.1 into dev

https://github.com/Gilead-BioStats/gsm/pull/1871

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-08 19:06:56 APPROVED

Pull Request 1870: Release v2.1.0

Merging dev into main

https://github.com/Gilead-BioStats/gsm/pull/1870

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-08 18:29:43 COMMENTED

Pull Request 1869: Closes #1863 address small bugs in MakeWorkflowList() run as intended

Merging fix-1863 into dev

https://github.com/Gilead-BioStats/gsm/pull/1869

Requester Date Requested Reviewers Review Status
zdz2101 2024-10-07 17:30:17 jwildfire COMMENTED

Pull Request 1867: Gsm v2.1.0 Release Candidate

Merging gsm-v2.1.0-rc into dev

https://github.com/Gilead-BioStats/gsm/pull/1867

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-10-04 14:31:53 jwildfire APPROVED

Pull Request 1865: Workflow updates.

Merging gsm.template-updates into dev

https://github.com/Gilead-BioStats/gsm/pull/1865

Requester Date Requested Reviewers Review Status
samussiah 2024-10-01 15:01:35 lauramaxwell

Pull Request 1864: Load/Save - Take 2

Merging template-refactor-take2 into dev

https://github.com/Gilead-BioStats/gsm/pull/1864

Requester Date Requested Reviewers Review Status
jwildfire 2024-09-30 21:36:28 COMMENTED

Pull Request 1862: Closes #1859 checks and updates qualification tests in test/testqualification to align with new workflows for v2.1.0 release

Merging fix-1859 into dev

https://github.com/Gilead-BioStats/gsm/pull/1862

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-26 19:51:16 andersonjake1988 COMMENTED

Pull Request 1861: Run {gsm} using local data store.

Merging gsm.template-updates into dev

https://github.com/Gilead-BioStats/gsm/pull/1861

Requester Date Requested Reviewers Review Status
samussiah 2024-09-25 17:43:50 jwildfire COMMENTED

Pull Request 1856: Add rbm-viz v2.1.0.

Merging fix-1855 into dev

https://github.com/Gilead-BioStats/gsm/pull/1856

Requester Date Requested Reviewers Review Status
samussiah 2024-09-24 13:11:22 APPROVED

Pull Request 1853: Discuss #1848 sections of package where there’s a difference of usage between gt vs “not”- gt

Merging fix-1848 into dev

https://github.com/Gilead-BioStats/gsm/pull/1853

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-19 20:18:58 COMMENTED

Pull Request 1852: Ingest modular

Merging ingest-modular into ingest

https://github.com/Gilead-BioStats/gsm/pull/1852

Requester Date Requested Reviewers Review Status
jwildfire 2024-09-19 16:31:37 samussiah COMMENTED

Pull Request 1851: Update checkSpec() cli message to handle _all required

Merging fix-1845 into dev

https://github.com/Gilead-BioStats/gsm/pull/1851

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-19 13:31:01 jwildfire samussiah APPROVED

Pull Request 1850: Closes #1653 adds Flag Over Time Widget to Study Overview as a tab

Merging fix-1653-v0.2.1 into dev

https://github.com/Gilead-BioStats/gsm/pull/1850

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-18 17:53:55 jwildfire COMMENTED

Pull Request 1849: MakeStudyInfo() function

Merging fix-1820 into dev

https://github.com/Gilead-BioStats/gsm/pull/1849

Requester Date Requested Reviewers Review Status
jonthegeek 2024-09-17 20:31:37 APPROVED

Pull Request 1847: make analysis workflow work

Merging workflow-tweaks into ingest

https://github.com/Gilead-BioStats/gsm/pull/1847

Requester Date Requested Reviewers Review Status
samussiah 2024-09-17 15:14:12 jonthegeek lauramaxwell APPROVED

Pull Request 1844: Add subjid to EDC domains in mapping workflow.

Merging fix-1761 into ingest

https://github.com/Gilead-BioStats/gsm/pull/1844

Requester Date Requested Reviewers Review Status
samussiah 2024-09-13 16:53:31 lauramaxwell APPROVED

Pull Request 1843: MakeMetricTable()

Merging fix-1835 into dev

https://github.com/Gilead-BioStats/gsm/pull/1843

Requester Date Requested Reviewers Review Status
jonthegeek 2024-09-13 16:11:28 COMMENTED

Pull Request 1841: Refactor Data Ingestion Workflow

Merging ingest into dev

https://github.com/Gilead-BioStats/gsm/pull/1841

Requester Date Requested Reviewers Review Status
jwildfire 2024-09-13 09:16:58 samussiah COMMENTED

Pull Request 1839: skip Analysis_ checks in checkSpec

Merging fix-1837 into dev

https://github.com/Gilead-BioStats/gsm/pull/1839

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-12 21:56:47

Pull Request 1833: Closes #1636 allows Visualize_Metric() to run on just results

Merging fix-1636 into dev

https://github.com/Gilead-BioStats/gsm/pull/1833

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-11 22:39:35 COMMENTED

Pull Request 1831: Closes #1728 Adds footnote to scatterplot widget

Merging fix-1728 into dev

https://github.com/Gilead-BioStats/gsm/pull/1831

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-10 17:54:23 COMMENTED

Pull Request 1829: Closes #1795 add assertions/stopifnot for widget inputs

Merging fix-1795 into dev

https://github.com/Gilead-BioStats/gsm/pull/1829

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-09 19:18:56 COMMENTED

Pull Request 1828: Update sample reporting data

Merging fix-1800 into dev

https://github.com/Gilead-BioStats/gsm/pull/1828

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-09 17:48:52 APPROVED

Pull Request 1827: Add all required spec tables to workflows

Merging fix-1819 into dev

https://github.com/Gilead-BioStats/gsm/pull/1827

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-06 16:00:38 jwildfire CHANGES_REQUESTED

Pull Request 1826: Update PR template

Merging fix-1825 into dev

https://github.com/Gilead-BioStats/gsm/pull/1826

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-05 20:51:10 APPROVED

Pull Request 1824: Closes #1686 Renders a message in KRI_Report() when there are 0 rows in the summary table

Merging fix-1686 into dev

https://github.com/Gilead-BioStats/gsm/pull/1824

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-05 20:30:12 COMMENTED

Pull Request 1817: Cloes #1678 standardize use of cli_inform() and cli_warn()

Merging fix-1678 into dev

https://github.com/Gilead-BioStats/gsm/pull/1817

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-05 16:09:46 jonthegeek COMMENTED

Pull Request 1815: Closes #1779 Enhance CombineSpecs() with deduplication, enforcing required and adding checks for type

Merging fix-1779 into dev

https://github.com/Gilead-BioStats/gsm/pull/1815

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-04 19:36:26 jonthegeek APPROVED

Pull Request 1814: Add type validation to CheckSpec()

Merging fix-1810 into dev

https://github.com/Gilead-BioStats/gsm/pull/1814

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-04 15:44:14 APPROVED

Pull Request 1813: gsm extensions vignette

Merging fix-1805 into dev

https://github.com/Gilead-BioStats/gsm/pull/1813

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-04 14:29:35 COMMENTED

Pull Request 1812: Closes #1722 Study Status Table display bugfix of indiscriminant first five attributes

Merging fix-1722 into dev

https://github.com/Gilead-BioStats/gsm/pull/1812

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-03 19:26:49 COMMENTED

Pull Request 1811: Closes #1760 Updating dropdown menu for articles in website

Merging fix-1760 into dev

https://github.com/Gilead-BioStats/gsm/pull/1811

Requester Date Requested Reviewers Review Status
zdz2101 2024-09-03 16:51:27 APPROVED

Pull Request 1809: Simpler depends

Merging withr-depends into dev

https://github.com/Gilead-BioStats/gsm/pull/1809

Requester Date Requested Reviewers Review Status
jonthegeek 2024-09-03 16:37:13 APPROVED

Pull Request 1808: Add type field and query columns to all spec s

Merging fix-1778 into dev

https://github.com/Gilead-BioStats/gsm/pull/1808

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-09-03 13:11:23 jwildfire dpastoor APPROVED

Pull Request 1803: Report_StudyInfo: Show/Hide

Merging fix-1802 into dev

https://github.com/Gilead-BioStats/gsm/pull/1803

Requester Date Requested Reviewers Review Status
jonthegeek 2024-08-28 13:23:51 APPROVED

Pull Request 1798: Implement filter args in Input_Rate.

Merging fix-1784 into dev

https://github.com/Gilead-BioStats/gsm/pull/1798

Requester Date Requested Reviewers Review Status
jonthegeek 2024-08-22 17:47:16 jwildfire

Pull Request 1791: Add a function to cleanly convert Params to Labels.

Merging fix-1790 into dev

https://github.com/Gilead-BioStats/gsm/pull/1791

Requester Date Requested Reviewers Review Status
jonthegeek 2024-08-19 21:34:15 jwildfire CHANGES_REQUESTED

Pull Request 1789: Add explicit snapshot date subset to Widget_GroupOverview .

Merging fix-1787 into dev

https://github.com/Gilead-BioStats/gsm/pull/1789

Requester Date Requested Reviewers Review Status
samussiah 2024-08-19 17:56:30 jwildfire CHANGES_REQUESTED

Pull Request 1786: Use required param from spec in CheckSpec()

Merging fix-1777 into reporting-workflow

https://github.com/Gilead-BioStats/gsm/pull/1786

Requester Date Requested Reviewers Review Status
lauramaxwell 2024-08-19 13:54:18 APPROVED