Man pages for sdtmchecks
Data Quality Checks for Study Data Tabulation Model (SDTM) Datasets
| check_ae_aeacn_ds_disctx_covid | Check for COVID-19 AE with DRUG WITHDRAWN action without... |
| check_ae_aeacnoth | Check for null AEACNOT1/2 when AEACNOTH = 'MULTIPLE' |
| check_ae_aeacnoth_ds_disctx | Check if, whenever a patient experiences an AE leading to... |
| check_ae_aeacnoth_ds_stddisc_covid | Check for COVID-19 AE leading to Study Discon without DS... |
| check_ae_aedecod | Check for missing AEDECOD values |
| check_ae_aedthdtc_aesdth | Check AEs with AEDTHDTC value but AESDTH not "Y" |
| check_ae_aedthdtc_ds_death | Check for missing AEDTHDTC where DS indicates death due to AE |
| check_ae_aelat | Check if AESOC has Eye, and Affected Eye is missing |
| check_ae_aeout | Check for inconsistency between AE outcome (AEOUT) and death... |
| check_ae_aeout_aeendtc_aedthdtc | Check for AE outcome (AEOUT) of 'FATAL' with non-missing... |
| check_ae_aeout_aeendtc_nonfatal | Check for non-fatal AEs with inconsistent AEOUT and AEENDTC |
| check_ae_aerel | Check for AEREL1 - AERELN when AEREL is missing and when... |
| check_ae_aesdth_aedthdtc | Check AEs with AESDTH of "Y" but No AEDTHDTC Value |
| check_ae_aestdtc_after_aeendtc | Check that all AE start dates are on or before AE end dates |
| check_ae_aestdtc_after_dd | Check for AE dates occurring after death date |
| check_ae_aetoxgr | Check for missing AETOXGR and/or AESEV values |
| check_ae_death | Check for Grade 5 AE death variable consistency |
| check_ae_death_ds_discon | Check if death in AE then there should be a study discon form |
| check_ae_ds_partial_death_dates | Check for partial death dates in AE and DS |
| check_ae_dup | Check for duplicate AE entries |
| check_ae_fatal | Check for death variable consistency when AEOUT=="FATAL" |
| check_ae_withdr_ds_discon | Check if an AE leading to drug being withdrawn is reflected... |
| check_ce_missing_month | Check for clinical events dates with year and day known but... |
| check_cm_cmdecod | Check for missing CMDECOD values |
| check_cm_cmindc | Check for concomitant medication indication with text string... |
| check_cm_cmlat | Check if ocular concomitant medication has laterality missing... |
| check_cm_cmlat_prior_ocular | Check if ocular concomitant medication has laterality missing... |
| check_cm_missing_month | Check for conmed dates with year and day known but month... |
| check_dd_ae_aedthdtc_ds_dsstdtc | Check if death date is the same in AE and DS domains |
| check_dd_ae_aeout_aedthdtc | Check if there is a death date and AEOUT='FATAL' agreement |
| check_dd_death_date | Check if patient with Death due to AE also has Death record... |
| check_dm_actarm_arm | Check DM where ARM is not equal to ACTARM |
| check_dm_ae_ds_death | Check if death reported in DM then death indicator also... |
| check_dm_age_missing | Check for patients with suspicious age values |
| check_dm_armcd | Check for missing ARM or ARMCD values in DM |
| check_dm_dthfl_dthdtc | Check that when DM.DTHFL is Y, DM.DTHDTC does not have a... |
| check_dm_usubjid_ae_usubjid | Check patients in the DM dataset who do not have records in... |
| check_dm_usubjid_dup | Check duplicate patient records in DM based on USUBJID |
| check_ds_ae_discon | Check for treatment discontinuation consistency between DS... |
| check_ds_dsdecod_death | Check for study discontinuation record if death indicated |
| check_ds_dsdecod_dsstdtc | Check DS with death record but no death date |
| check_ds_dsscat | Check for patients with more than one study discontinuation... |
| check_ds_dsterm_death_due_to | Check missing cause of death information in DS |
| check_ds_duplicate_randomization | Check for duplicate randomization records for a patient |
| check_ds_ex_after_discon | Check for patients who had Start/End date of treatment after... |
| check_ds_multdeath_dsstdtc | Check DS with multiple death records with death dates, where... |
| check_ds_sc_strat | Check if randomized patients are missing stratification... |
| check_dv_ae_aedecod_covid | Check for consistency between DV and AE for COVID-19 events |
| check_dv_covid | Check for consistency in COVID-19 DV variables, DVREAS and... |
| check_ec_sc_lat | Check if Study Drug is not administered in the Study Eye |
| check_eg_egdtc_visit_ordinal_error | Check that all ECG datetimes are earlier than last visit's... |
| check_ex_dup | Check for duplicate EX records |
| check_ex_exdose_exoccur | Check for Missing EXDOSE. |
| check_ex_exdose_pos_exoccur_no | Check for EXDOSE>0 When EXOCCUR is not "Y" |
| check_ex_exdosu | Check for missing EXDOSU records |
| check_ex_exoccur_exdose_exstdtc | Check for Invalid EXDOSE (Dose per Administration) and... |
| check_ex_exoccur_mis_exdose_nonmis | Check for missing EXOCCUR but EXDOSE not missing |
| check_ex_exstdtc_after_dd | Check for EX dates occurring after death date |
| check_ex_exstdtc_after_exendtc | Check that all exposure start dates are on or before exposure... |
| check_ex_exstdtc_visit_ordinal_error | Check that all EX start dates are earlier than last visit's... |
| check_ex_extrt_exoccur | Check for EX records where EXTRT is missing |
| check_ex_infusion_exstdtc_exendtc | Check that an infusion drug has same start/end exposure... |
| check_ex_visit | Check for missing EX.VISIT |
| check_lb_lbdtc_after_dd | Check for LB dates occurring after death date |
| check_lb_lbdtc_visit_ordinal_error | Check that all LB dates are duplicated or earlier than last... |
| check_lb_lbstnrlo_lbstnrhi | Check for missing lab reference ranges (LBSTNRLO, LBSTNRHI) |
| check_lb_lbstresc_char | Check LBORRES/LBSTRESC populated with number beginning with... |
| check_lb_lbstresn_missing | Check missing standard lab values (LBSTRESN/LBSTRESC) |
| check_lb_lbstresu | Check for missing lab units (LBSTRESU) |
| check_lb_missing_month | Check for lab dates with year and day known but month unknown |
| check_mh_missing_month | Check for MH dates with year and day known but month unknown |
| check_mi_mispec | Check for missing values in the MISPEC variable |
| check_oe_bcva_1m_late_early_tot | Check if 1m BCVA test stops too late, too early and has... |
| check_oe_bcva_4m_late_early_tot | Check if 4m BCVA test stops too late, too early and has... |
| check_oe_bcva_4m_vs_1m_req | Check if 1m BCVA test is completed per BCVA 4m result |
| check_oe_bcva_tot_mismatch | Check mismatch between Derived BCVA Total Score & Total BCVA... |
| check_oe_sc_lat_count_fingers | Check if Post Treatment Count Fingers in Study Eye laterality... |
| check_pr_missing_month | Check for procedure dates with year and day known but month... |
| check_pr_prlat | Check if ocular procedures/surgeries has laterality missing... |
| check_qs_dup | Check for multiple dates at the same visit in QS |
| check_qs_qsdtc_after_dd | Check for QS dates occurring after death date |
| check_qs_qsdtc_visit_ordinal_error | Check that all QS dates are duplicated or earlier than last... |
| check_qs_qsstat_qsreasnd | Check to confirm that there is a reason for a questionnaire... |
| check_qs_qsstat_qsstresc | Check for non-missing QSSTRESC if QSSTAT is NOT DONE |
| check_rs_rscat_rsscat | Check for patients with populated RSSCAT but missing RSCAT. |
| check_rs_rsdtc_across_visit | Check RS records where the same date occurs across multiple... |
| check_rs_rsdtc_visit | Check missing RSDTC and VISIT |
| check_rs_rsdtc_visit_ordinal_error | Check that all RS dates for INV Overall Response are... |
| check_sc_dm_eligcrit | Check SC Eye Meeting Eligibility Criteria assignments among... |
| check_sc_dm_seyeselc | Check SC Study Eye Selection assignments among DM patients |
| check_ss_ssdtc_alive_dm | Check non-missing last ALIVE status date in SS is before than... |
| check_ss_ssdtc_dead_ds | Check non-missing DEAD status date in SS and non-missing... |
| check_ss_ssdtc_dead_dthdtc | Check non-missing DEAD status date in SS and an according DM... |
| check_ss_ssstat_ssorres | Check for non-missing SSORRES if SSSTAT is NOT DONE |
| check_tr_dup | Check for duplicate TR records |
| check_tr_trdtc_across_visit | Check TR Longest Diameter Records where the same date occurs... |
| check_tr_trdtc_visit_ordinal_error | Check that all TR dates by INV are duplicated or earlier than... |
| check_tr_trstresn_ldiam | Check for TR records with missing TRSTRESN for Longest... |
| check_ts_aedict | Check for missing MedDRA version in TS |
| check_ts_cmdict | Check for missing WHODrug version in TS |
| check_ts_sstdtc_ds_consent | Check for missing SSTDTC (Study Start Date) in TS |
| check_tu_rs_new_lesions | Check for consistency between new lesions and overall PD... |
| check_tu_tudtc | Check for missing TUDTC values |
| check_tu_tudtc_across_visit | Check TU Records where the same date occurs across multiple... |
| check_tu_tudtc_visit_ordinal_error | Check that all TU dates are duplicated or earlier than last... |
| check_tu_tuloc_missing | Check for missing TULOC values |
| check_vs_height | Check for missing height values |
| check_vs_sbp_lt_dbp | Check that DBP is not higher than SBP in VS |
| check_vs_vsdtc_after_dd | Check for VS dates occurring after death date |
| convert_var_to_ascii | Remove non-ASCII characters from reported term in order for... |
| create_R_script | Create .R file with sdtmchecks function calls |
| diff_reports | Create a sdtmchecks list object with column indicating... |
| dtc_dupl_early | Check if start dates are duplicated or earlier than prior... |
| fail | Fail object |
| grapes-has_all-grapes | Check if data frame has all specified variables |
| grapes-has_any-grapes | Check if data frame has at least one of the specified... |
| grapes-lacks_all-grapes | Check if data frame is missing any of the specified variables |
| grapes-lacks_any-grapes | Check if data frame has at least one variable from a set of... |
| impute_day01 | Add day of "01" to dates that are in the format of "yyyy-mm" |
| is_sas_na | Check if the elements could be of any SAS missing data... |
| lacks_msg | Check data frame for mandatory variables and specify which... |
| missing_month | Function to check if month is missing while year and day are... |
| nickname | Nickname for package version |
| pass | Pass object |
| report_to_xlsx | Save report as an xlsx file |
| roche_derive_rave_row | Utility function to obtain Rave form name and row number |
| run_all_checks | Run all data checks in sdtmchecks package using parallel... |
| run_check | Run a single check in sdtmchecks package |
| sdtmchecksmeta | Metadata for sdtmchecks |
| sdtmchecks-package | sdtmchecks: Data Quality Checks for Study Data Tabulation... |
| truncate_var_strings | Utility function to truncate data in var_name |
