sdtmchecks 1.0.0 “CRAN Try”
Refinements of
existing data check functions
Misc package updates
- General updates for CRAN compliance, e.g. to DESCRIPTION file,
Roxygen headers, etc.
- Remove rm(list=ls())from sdtmchecksmeta.R (#375)
- Removed xls2list()function. If working with the
results ofrun_all_checks()it’s recommended to output
results to to .rds instead of parsing .xlsx files.
sdtmchecks 0.1.11.9008 “Light
Ice”
Refinements of
existing data check functions
- check_ae_aeacn_ds_disctx_covidadd more header and unit tests, update header description that the check
specifically looks for DSDECOD = ‘ADVERSE EVENT’ and include a note that
a single DSDECOD = ‘ADVERSE EVENT’ will yield a pass but there may be
multiple records in DS expected with this value #330
- check_ae_aeacnothadd more header and unit tests for NA, minor update to return message #328
- check_ae_aeoutfix logic for the scenario when AEOUT is not populated but there is a
non-missing AEDTHDTC, update return message (#318)
- check_ae_aesdth_aedthdtcinclude AETERM for easier querying, added more header examples, updated
return message. (#323).
Update associated unit test to include AETERM (#324).
- check_ae_aesdthdtc_aesdthbug fix for NA values not detected via original- !(AE[["AESDTH"]]=="Y")logic leading to possible false
negative result #247,
include AETERM for easier querying, added more header examples, updated
return message. (#322).
Update associated unit test to include AETERM (#324).
- check_dd_ae_aeout_aedthdtcfix logic for the scenario when AEOUT is not populated but there is a
non-missing AEDTHDTC, update return message. This check overlaps with- check_ae_aeout,
but both will be retained for now to avoid breaking changes (#310)
Misc package updates
- Update GitHub workflows (#316)
sdtmchecks 0.1.11 “Light Ice”
- Re-create sdtmchecksmeta.RData with MedDRA dictionary version 27.0
listed instead of 26.1 (#312)
Misc package updates
- Unit test accompanying new CE check check_ce_missing_month()previously created by@rymarinelliadded into
tests/testthat subdirectory
- Fix minor typo in README (#299)
- Add cran-comments.md (#305)
sdtmchecks 0.1.10 “Light Ice”
Refinements of
existing data check functions
New data check functions
- check_ce_missing_month()- flags if CE has a suspicious date value with year and day known but
month missing (#148),
with thanks to- @rymarinelli
- check_ae_aeout_aeendtc_nonfatal()- flags AEs with inconsistent AE outcome (AEOUT) and AE resolution date
(AEENDTC) for non-fatal AEs (based on AEOUT) (#113),
with thanks to- @J-Lox
Refinements of
existing report utilities
Misc package updates
- Specify version >= 1.1.1 for dplyr version in DESCRIPTION
- Replace “report_diff” with “Status” in globals.Rto
align with update indiff_reports()(#269)
sdtmchecks 0.1.9 “Bubble and
Squeak”
New report utility functions
- Added diff_reports()reporting function toutils.Rto compare report objects
generated fromrun_all_checks(),
enabling identification of records newly flagged (#264),
with thanks to@harriscw
- Include “report_diff” in globals.R(#265)
Misc package updates
- Automated security update in workflow (#268)
sdtmchecks 0.1.8 “Bubble and
Squeak”
Refinements of
existing data check functions
- check_tu_rs_new_lesionsupdated to include overall response of- PMDas an indicator
of progressive disease. Visit info also added to check result. (#197)
- check_ae_fatalupdated to address bug that was causing warning. Logic was subsequently
streamlined. (#215)
- Checks that expect specific preferred terms identifying Covid-19
related AEs were updated to warn if that metadata was not provided. (#220 &
#223)
- --SEQvariables were removed from checks. (#246)
Documentation updates
- Roxygen2 header updated to include @familyand@keywordfor data check function categories OPHTH and COVID
(#214)
- applied to the following data checks:
- COVID:
- check_ae_aeacn_ds_disctx_covid.R
- check_ae_aeacnoth_ds_stddisc_covid.R
- check_dv_ae_aedecod_covid.R
- check_dv_covid.R
 
- OPHTH:
- check_ae_aelat.R
- check_cm_cmlat.R
- check_cm_cmlat_prior_ocular.R
- check_oe_bcva_1m_late_early_tot.R
- check_oe_bcva_4m_late_early_tot.R
- check_oe_bcva_4m_vs_1m_req.R
- check_oe_bcva_tot_mismatch.R
- check_oe_sc_lat_count_fingers.R
- check_pr_prlat.R
- check_sc_dm_eligcrit.R
- check_sc_dm_seyeselc.R
 
 
sdtmchecks 0.1.6 “Bubble and
Squeak”
Refinements of
existing data check functions
New functions
- Added xls2list()reporting function to create a list from spreadsheet tabs using the
{openxlsx} package (#85)
- sdtmchecksmeta.RDatasaves as version=2 not version=3 for backwards compatibility with R <
3.5.0 when .RData loaded (#84)
Documentation updates
- New vignettes:
- Other minor updates:
- Edited @titleofcheck_ae_aeacn_ds_disctx_covid(),check_ae_aeacnoth_ds_stddisc_covid()to be single line to
address warning during package build
- Edited headers of dtc_dupl_early()andfail()in utils.R
- Commented out template assigned in _pkgdown.yml
file (#104)
- Added clickable version releases as links in News dropdown of
pkgdown site (#121)
- Edited headings in Get
started article (#114)
- Added a few bullet points to Writing
a New Check
- Updated pkgdown
site based on latest version of {Roxygen2} (v7.2.3)
instead of (v7.1.1).
DESCRIPTION reflects version in RoxygenNote, and associated
man/*.Rd files updated.
- Roxygen2 header updates to include @familyand@keywordfor functions inrun_all_checks.R,run_check.R,utils.R(#85)
- Moved sdtmchecks package information from utils.Rtosdtmchecks-package.R(#85)
 
Misc package updates
- Unit tests:
- Added unit testing (copied in from earlier internal Roche package
version) (#126, #112)
- Included more unit tests to expand coverage (#141),
with thanks to @harriscw(#137, #144, #145, #155, #162),@J-Lox(#147, #156),@laywang142(#199, #158, #153, #146),@sarabodach(#150, #151, #159, #160, #183)
- Added GitHub action for test coverage report produced by {covr} and uploaded to codecov (#163)
 
- README:
- Include badges on README:
- README.Rmd added to render README.md (#172)
- Add installation instructions from
“https://pharmaverse.r-universe.dev” (devel branch, default) #195, #226
- Specify recommended installation from main branch:
devtools::install_github("pharmaverse/sdtmchecks", ref = "main")
 
- Updated DESCRIPTION to specify:
- New dependency: {testthat}
- GitHub as Repository for sdtmchecks (#123)
- Config/testthat/edition: 3 (#138)
 
- Implemented {renv} for
package dependency management, adding renvignore, renv.lock, renv
subfolder and including updated .Rprofile (#111)
- Package version 0.1.5.1 used prior to update to 0.1.6
sdtmchecks 0.1.5 “Hunter Pi”
New data check functions
Refinements of
existing data check functions
- Updated existing data checks to list the nfunction
from {dplyr} in the header (#67):
Misc updates
- Clarification added to “Writing a New Check” Vignette
if contributor does not have write access to the repo (#65)
sdtmchecks 0.1.4 “Very Cool
Nickname”
Refinements of
existing data check functions
- Updated existing data checks
- check_lb_lbstresu()- add more text strings (NEGATIVE,
POSITIVE, NOT DONE) allowed for LBORRES to reduce false positives (#27)
- check_tr_trstresn_ldiam()- include a return message
that summarizes total TR records that are missing, NOT DONE, NOT
EVALUABLE to help with interpreting the output (#27)
- check_ae_aeacnoth_ds_disctx()- corrected typo in
return message (#56)
 
New functions
- New helper function utilities added to utils.R
- create_R_script()can use- sdtmchecksmeta.RDataas input to programmatically generate
an R script with function calls (#22)
- report_to_xlsx()to generate the output results from
selected data check functions as an .xlsx file including a tab for each
check with potential discrepancies flagged and a summary page with
conditional formatting to provide an overview of the results (#11)
 
New documentation
Misc updates
- Add CI/CD workflow (#2, #8)
- Add package nickname as nickname.RDataand reference indata.R,globals.R
- Remove repeated occurrence of convert_var_to_ascii()from utils.R (#31)
sdtmchecks 0.1.2
“The one without the nickname”
Misc updates
- Removed package nickname from Description
sdtmchecks 0.1.1 “Open Up”
Initial package deployment
- Initial deployment of open-source sdtmchecks Pharmaverse package, based on
code migrated from the internal Roche sdtmchecks package, which includes
a variety of data checks and utility functions
- All data check functions (check_xx....R) modified from
Roche-specific version to include:
- Updated roxygen2 headers
with generalized examples
- Pre-processing in the function call
(preproc=identity,...) to allow company-specific
pre-processing
 
- Proprietary dataset call-ins removed
- Metadata corresponding to all data check functions sdtmchecksmeta.RDataadded to the data subdirectory; Roche-specific acronyms removed from
descriptive text
- Utility functions added within separate roche_utils.Rfile for Roche-specific processing and to serve as a reference for
implementation of company-specific pre-processing
- globals.Radded with explicit list to pass through- utils::globalVariables()
- Other general utility functions that are invoked within check_xx....Rfunctions consolidated from separate .R scripts intoutils.R:
- README, LICENSE, DESCRIPTION, _pkgdown.yml, vignette files tailored
to github.com/pharmaverse (#1)
- Package logo added to man/figures
- Package site created via pkgdown
New data check
functions (post-migration)
- check_ae_aeacnoth_ds_disctx()flags if an AE record
indicates person discontinued from study but there is no corresponding
DS record indicating study discontinuation
(- where DS.DSSCAT = "STUDY COMPLETION/EARLY DISCONTINUATION" and DS.DSDECOD != "COMPLETED")
(#3)