Changelog

Source: NEWS.md

sdtm.oak V0.2.0

• DM Domain: New functions calc_min_max_date() and oak_calc_ref_dates() to support DM domain programming.
• Supplementary Qualifier SUPP Domains - New functiongenerate_sdtm_supp() to facilitate the programming of supplemental qualifier domains.
• Bug Fixes:
  • Resolved an issue in mapping algorithms to prevent overwriting results.
  • Fixed the problems() function to ensure blank values are excluded from warning messages when converting dates to ISO8601 format.
  • Corrected controlled terminology functions to alert users when a value cannot be mapped according to the controlled terms in assign_ct() and hardcode_ct() functions.

With this release, users can now efficiently create the DM domain as well as various SDTM domains across Findings, Events, Findings About, Supplemental qualifiers and Intervention classes, significantly broadening the range of supported domains.

sdtm.oak V0.1.1

CRAN release: 2024-11-12

Fixed the bug that was causing test cases to fail. Updated derive_blfl() function to account for baseline_timepoints. Typo updates in the documentation.

sdtm.oak V0.1.0

CRAN release: 2024-09-03

The V0.1.0 release of {sdtm.oak} users can create the majority of the SDTM domains. Domains that are NOT in scope for the V0.1.0 release are DM, Trial Design Domains, SV, SE, RELREC, Associated Person domains, and EPOCH Variable across all domains.

• Functions for commonly used SDTM mapping Algorithms
  • assign_no_ct() to process assign_no_ct algorithm
  • assign_ct() to process assign_ct algorithm
  • hardcode_no_ct() to process hardcode_no_ct algorithm
  • hardcode_ct() to process hardcode_ct algorithm
  • assign_datetime() to process assign_datetime algorithm
  • condition_add() to process condition_add algorithm (if/else conditions)
• Functions for SDTM derived variables
  • derive_blfl() to Derive Baseline Flag or Last Observation Before Exposure Flag
  • derive_seq() to Derive the sequence number (–SEQ) variable
  • derive_study_day() to Derive study day
  • create_iso8601() for ISO8601 date, datetime conversion.
• Functions to support {sdtm.oak}
  • generate_oak_id_vars() to derive oak id variables
  • read_ct_spec() to read the controlled terminology spec
  • Functions to create conditioned dataframes to support if then else conditions in SDTM mappings
• Articles
  • Algorithms
  • Creating an interventions SDTM domain
  • Creating a Findings SDTM domain
  • Conditioned Data Frames
  • Converting dates, times or date-times to ISO 8601
  • Path to Automation

Further details on this Release

• New function for creating conditioned data frames: condition_add().
• New pipe operator: %.>% for explicit dot placeholder placement.
• oak_id_vars() is now an exported function.
• New function: derive_seq() for deriving a sequence number variable.
• New function: assign_datetime() for deriving an ISO8601 date-time variable.
• New function: derive_study_day() for study day calculation.
• New functions for basic SDTM derivations: assign_no_ct(), assign_ct(), hardcode_no_ct() and hardcode_ct().
• New functions for handling controlled terminologies: read_ct_spec(), read_ct_spec_example(), ct_spec_example() and ct_map().
• New function create_iso8601() for conversion of vectors of dates, times or date-times to ISO8601 format.