| 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 study discontinuation, they also have a DS record indicating this. |
| check_ae_aeacnoth_ds_stddisc_covid |
Check for COVID-19 AE leading to Study Discon without DS Study Discon |
| check_ae_aeacn_ds_disctx_covid |
Check for COVID-19 AE with DRUG WITHDRAWN action without "ADVERSE EVENT" for DS Trt Discon |
| 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 date (AEDTHDTC) |
| check_ae_aeout_aeendtc_aedthdtc |
Check for AE outcome (AEOUT) of 'FATAL' with non-missing resolution date that is not equal to the death date |
| 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 AEREL is unexpected |
| 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Check if an AE leading to drug being withdrawn is reflected in DS |
| check_ce_missing_month |
Check for clinical events dates with year and day known but month unknown |
| check_cm_cmdecod |
Check for missing CMDECOD values |
| check_cm_cmindc |
Check for concomitant medication indication with text string "PROPHYL" when not given for prophylaxis |
| check_cm_cmlat |
Check if ocular concomitant medication has laterality missing or laterality field is populated but route is not eye-related. |
| check_cm_cmlat_prior_ocular |
Check if ocular concomitant medication has laterality missing for specific "PRIOR OCULAR THERAPIES AND TREATMENTS" (or similar names) CRF page. |
| check_cm_missing_month |
Check for conmed dates with year and day known but month unknown |
| 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 in DS |
| 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 present in DS or AE |
| 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 missing value, and vice versa |
| check_dm_usubjid_ae_usubjid |
Check patients in the DM dataset who do not have records in the AE dataset |
| check_dm_usubjid_dup |
Check duplicate patient records in DM based on USUBJID |
| check_ds_ae_discon |
Check for treatment discontinuation consistency between DS and AE |
| 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 records |
| 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 study discontinuation date |
| check_ds_multdeath_dsstdtc |
Check DS with multiple death records with death dates, where death dates do not match |
| check_ds_sc_strat |
Check if randomized patients are missing stratification factor data |
| 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 DVEPRELI |
| 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 (possible datetime data entry error) |
| 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 Missing/Incomplete EXSTDTC (Start Date) Values for valid exposures |
| 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 end dates |
| check_ex_exstdtc_visit_ordinal_error |
Check that all EX start dates are earlier than last visit's (possible datetime data entry error) |
| 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 dates, also including missing start/end dates |
| 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 visit's (possible datetime data entry error) |
| check_lb_lbstnrlo_lbstnrhi |
Check for missing lab reference ranges (LBSTNRLO, LBSTNRHI) |
| check_lb_lbstresc_char |
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_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 correct total |
| check_oe_bcva_4m_late_early_tot |
Check if 4m BCVA test stops too late, too early and has correct total |
| 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 Score from Data |
| check_oe_sc_lat_count_fingers |
Check if Post Treatment Count Fingers in Study Eye laterality does not match with Subject Characteristics Study Eye laterality |
| check_pr_missing_month |
Check for procedure dates with year and day known but month unknown |
| check_pr_prlat |
Check if ocular procedures/surgeries has laterality missing for CRF pages which contain the word "OCULAR" (and not "NON-OCULAR"). |
| 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 visit's (possible datetime data entry error) |
| check_qs_qsstat_qsreasnd |
Check to confirm that there is a reason for a questionnaire being marked as not done |
| 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 visits |
| 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 duplicated or earlier than last visit's (possible date entry error) |
| check_sc_dm_eligcrit |
Check SC Eye Meeting Eligibility Criteria assignments among DM patients |
| 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 death date in DM |
| check_ss_ssdtc_dead_ds |
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_dthdtc |
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_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 across multiple visits |
| check_tr_trdtc_visit_ordinal_error |
Check that all TR dates by INV are duplicated or earlier than last visit's (possible date entry error) |
| check_tr_trstresn_ldiam |
Check for TR records with missing TRSTRESN for Longest Diameter (LDIAM) |
| 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 response |
| check_tu_tudtc |
Check for missing TUDTC values |
| check_tu_tudtc_across_visit |
Check TU Records where the same date occurs across multiple visits |
| check_tu_tudtc_visit_ordinal_error |
Check that all TU dates are duplicated or earlier than last visit's (possible datetime data entry error) |
| 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 |
| create_R_script |
Create .R file with sdtmchecks function calls |
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