| Check for COVID-19 AE with DRUG WITHDRAWN action without "ADVERSE EVENT" for DS Trt Discon | check_ae_aeacn_ds_disctx_covid |
| Check for null AEACNOT1/2 when AEACNOTH = 'MULTIPLE' | check_ae_aeacnoth |
| Check if, whenever a patient experiences an AE leading to study discontinuation, they also have a DS record indicating this. | check_ae_aeacnoth_ds_disctx |
| Check for COVID-19 AE leading to Study Discon without DS Study Discon | check_ae_aeacnoth_ds_stddisc_covid |
| Check for missing AEDECOD values | check_ae_aedecod |
| Check AEs with AEDTHDTC value but AESDTH not "Y" | check_ae_aedthdtc_aesdth |
| Check for missing AEDTHDTC where DS indicates death due to AE | check_ae_aedthdtc_ds_death |
| Check if AESOC has Eye, and Affected Eye is missing | check_ae_aelat |
| Check for inconsistency between AE outcome (AEOUT) and death date (AEDTHDTC) | check_ae_aeout |
| Check for AE outcome (AEOUT) of 'FATAL' with non-missing resolution date that is not equal to the death date | check_ae_aeout_aeendtc_aedthdtc |
| Check for non-fatal AEs with inconsistent AEOUT and AEENDTC | check_ae_aeout_aeendtc_nonfatal |
| Check for AEREL1 - AERELN when AEREL is missing and when AEREL is unexpected | check_ae_aerel |
| Check AEs with AESDTH of "Y" but No AEDTHDTC Value | check_ae_aesdth_aedthdtc |
| Check that all AE start dates are on or before AE end dates | check_ae_aestdtc_after_aeendtc |
| Check for AE dates occurring after death date | check_ae_aestdtc_after_dd |
| Check for missing AETOXGR and/or AESEV values | check_ae_aetoxgr |
| Check for Grade 5 AE death variable consistency | check_ae_death |
| Check if death in AE then there should be a study discon form | check_ae_death_ds_discon |
| Check for partial death dates in AE and DS | check_ae_ds_partial_death_dates |
| Check for duplicate AE entries | check_ae_dup |
| Check for death variable consistency when AEOUT=="FATAL" | check_ae_fatal |
| Check if an AE leading to drug being withdrawn is reflected in DS | check_ae_withdr_ds_discon |
| Check for clinical events dates with year and day known but month unknown | check_ce_missing_month |
| Check for missing CMDECOD values | check_cm_cmdecod |
| Check for concomitant medication indication with text string "PROPHYL" when not given for prophylaxis | check_cm_cmindc |
| Check if ocular concomitant medication has laterality missing or laterality field is populated but route is not eye-related. | check_cm_cmlat |
| Check if ocular concomitant medication has laterality missing for specific "PRIOR OCULAR THERAPIES AND TREATMENTS" (or similar names) CRF page. | check_cm_cmlat_prior_ocular |
| Check for conmed dates with year and day known but month unknown | check_cm_missing_month |
| Check if death date is the same in AE and DS domains | check_dd_ae_aedthdtc_ds_dsstdtc |
| Check if there is a death date and AEOUT='FATAL' agreement | check_dd_ae_aeout_aedthdtc |
| Check if patient with Death due to AE also has Death record in DS | check_dd_death_date |
| Check DM where ARM is not equal to ACTARM | check_dm_actarm_arm |
| Check if death reported in DM then death indicator also present in DS or AE | check_dm_ae_ds_death |
| Check for patients with suspicious age values | check_dm_age_missing |
| Check for missing ARM or ARMCD values in DM | check_dm_armcd |
| Check that when DM.DTHFL is Y, DM.DTHDTC does not have a missing value, and vice versa | check_dm_dthfl_dthdtc |
| Check patients in the DM dataset who do not have records in the AE dataset | check_dm_usubjid_ae_usubjid |
| Check duplicate patient records in DM based on USUBJID | check_dm_usubjid_dup |
| Check for treatment discontinuation consistency between DS and AE | check_ds_ae_discon |
| Check for study discontinuation record if death indicated | check_ds_dsdecod_death |
| Check DS with death record but no death date | check_ds_dsdecod_dsstdtc |
| Check for patients with more than one study discontinuation records | check_ds_dsscat |
| Check missing cause of death information in DS | check_ds_dsterm_death_due_to |
| Check for duplicate randomization records for a patient | check_ds_duplicate_randomization |
| Check for patients who had Start/End date of treatment after study discontinuation date | check_ds_ex_after_discon |
| Check DS with multiple death records with death dates, where death dates do not match | check_ds_multdeath_dsstdtc |
| Check if randomized patients are missing stratification factor data | check_ds_sc_strat |
| Check for consistency between DV and AE for COVID-19 events | check_dv_ae_aedecod_covid |
| Check for consistency in COVID-19 DV variables, DVREAS and DVEPRELI | check_dv_covid |
| Check if Study Drug is not administered in the Study Eye | check_ec_sc_lat |
| Check that all ECG datetimes are earlier than last visit's (possible datetime data entry error) | check_eg_egdtc_visit_ordinal_error |
| Check for duplicate EX records | check_ex_dup |
| Check for Missing EXDOSE. | check_ex_exdose_exoccur |
| Check for EXDOSE>0 When EXOCCUR is not "Y" | check_ex_exdose_pos_exoccur_no |
| Check for missing EXDOSU records | check_ex_exdosu |
| Check for Invalid EXDOSE (Dose per Administration) and Missing/Incomplete EXSTDTC (Start Date) Values for valid exposures | check_ex_exoccur_exdose_exstdtc |
| Check for missing EXOCCUR but EXDOSE not missing | check_ex_exoccur_mis_exdose_nonmis |
| Check for EX dates occurring after death date | check_ex_exstdtc_after_dd |
| Check that all exposure start dates are on or before exposure end dates | check_ex_exstdtc_after_exendtc |
| Check that all EX start dates are earlier than last visit's (possible datetime data entry error) | check_ex_exstdtc_visit_ordinal_error |
| Check for EX records where EXTRT is missing | check_ex_extrt_exoccur |
| Check that an infusion drug has same start/end exposure dates, also including missing start/end dates | check_ex_infusion_exstdtc_exendtc |
| Check for missing EX.VISIT | check_ex_visit |
| Check for LB dates occurring after death date | check_lb_lbdtc_after_dd |
| Check that all LB dates are duplicated or earlier than last visit's (possible datetime data entry error) | check_lb_lbdtc_visit_ordinal_error |
| Check for missing lab reference ranges (LBSTNRLO, LBSTNRHI) | check_lb_lbstnrlo_lbstnrhi |
| Check LBORRES/LBSTRESC populated with number beginning with character '>' or '<', which will yield missing AVAL in ADaM and records will be omitted in analyses such as Hy's Law | check_lb_lbstresc_char |
| Check missing standard lab values (LBSTRESN/LBSTRESC) | check_lb_lbstresn_missing |
| Check for missing lab units (LBSTRESU) | check_lb_lbstresu |
| Check for lab dates with year and day known but month unknown | check_lb_missing_month |
| Check for MH dates with year and day known but month unknown | check_mh_missing_month |
| Check for missing values in the MISPEC variable | check_mi_mispec |
| Check if 1m BCVA test stops too late, too early and has correct total | check_oe_bcva_1m_late_early_tot |
| Check if 4m BCVA test stops too late, too early and has correct total | check_oe_bcva_4m_late_early_tot |
| Check if 1m BCVA test is completed per BCVA 4m result | check_oe_bcva_4m_vs_1m_req |
| Check mismatch between Derived BCVA Total Score & Total BCVA Score from Data | check_oe_bcva_tot_mismatch |
| Check if Post Treatment Count Fingers in Study Eye laterality does not match with Subject Characteristics Study Eye laterality | check_oe_sc_lat_count_fingers |
| Check for procedure dates with year and day known but month unknown | check_pr_missing_month |
| Check if ocular procedures/surgeries has laterality missing for CRF pages which contain the word "OCULAR" (and not "NON-OCULAR"). | check_pr_prlat |
| Check for multiple dates at the same visit in QS | check_qs_dup |
| Check for QS dates occurring after death date | check_qs_qsdtc_after_dd |
| Check that all QS dates are duplicated or earlier than last visit's (possible datetime data entry error) | check_qs_qsdtc_visit_ordinal_error |
| Check to confirm that there is a reason for a questionnaire being marked as not done | check_qs_qsstat_qsreasnd |
| Check for non-missing QSSTRESC if QSSTAT is NOT DONE | check_qs_qsstat_qsstresc |
| Check for patients with populated RSSCAT but missing RSCAT. | check_rs_rscat_rsscat |
| Check RS records where the same date occurs across multiple visits | check_rs_rsdtc_across_visit |
| Check missing RSDTC and VISIT | check_rs_rsdtc_visit |
| Check that all RS dates for INV Overall Response are duplicated or earlier than last visit's (possible date entry error) | check_rs_rsdtc_visit_ordinal_error |
| Check SC Eye Meeting Eligibility Criteria assignments among DM patients | check_sc_dm_eligcrit |
| Check SC Study Eye Selection assignments among DM patients | check_sc_dm_seyeselc |
| Check non-missing last ALIVE status date in SS is before than death date in DM | check_ss_ssdtc_alive_dm |
| Check non-missing DEAD status date in SS and non-missing according DS record with death date where status date is greater or equal to death date | check_ss_ssdtc_dead_ds |
| Check non-missing DEAD status date in SS and an according DM record with death date where status date is greater or equal to death date | check_ss_ssdtc_dead_dthdtc |
| Check for non-missing SSORRES if SSSTAT is NOT DONE | check_ss_ssstat_ssorres |
| Check for duplicate TR records | check_tr_dup |
| Check TR Longest Diameter Records where the same date occurs across multiple visits | check_tr_trdtc_across_visit |
| Check that all TR dates by INV are duplicated or earlier than last visit's (possible date entry error) | check_tr_trdtc_visit_ordinal_error |
| Check for TR records with missing TRSTRESN for Longest Diameter (LDIAM) | check_tr_trstresn_ldiam |
| Check for missing MedDRA version in TS | check_ts_aedict |
| Check for missing WHODrug version in TS | check_ts_cmdict |
| Check for missing SSTDTC (Study Start Date) in TS | check_ts_sstdtc_ds_consent |
| Check for consistency between new lesions and overall PD response | check_tu_rs_new_lesions |
| Check for missing TUDTC values | check_tu_tudtc |
| Check TU Records where the same date occurs across multiple visits | check_tu_tudtc_across_visit |
| Check that all TU dates are duplicated or earlier than last visit's (possible datetime data entry error) | check_tu_tudtc_visit_ordinal_error |
| Check for missing TULOC values | check_tu_tuloc_missing |
| Check for missing height values | check_vs_height |
| Check that DBP is not higher than SBP in VS | check_vs_sbp_lt_dbp |
| Check for VS dates occurring after death date | check_vs_vsdtc_after_dd |
| Create .R file with sdtmchecks function calls | create_R_script |
| Create a sdtmchecks list object with column indicating whether the issue was previously seen | diff_reports |
| Run all data checks in sdtmchecks package using parallel processing | run_all_checks |
| Run a single check in sdtmchecks package | run_check |
| Metadata for sdtmchecks | sdtmchecksmeta |
