Check name | Description | Details | Domain(s) | Category | Priority | |
---|---|---|---|---|---|---|
|
|
|
|
|
| |
1 | check_ae_aeacn_ds_disctx_covid | Check patient(s) with COVID-related AEs leading to Treatment Discon, but no Treatment Discon due to AE in DS | * This check identifies COVID AE records with AEACN[n] indicated as leading to Drug Withdrawn without a Treatment Discon record due to AE in DS * Check can only run on studies with DS.DSSPID to identify entries on the DISCTX form * NOTE: COVID-19 AEs identified based on preferred terms from MedDRA v27.0 COVID-19 SMQ (Narrow) or earlier identified version based on TS | AE, DS | Covid-19 | Low |
2 | check_ae_aeacnoth | Check for null AEACNOT[1/2] when AEACNOTH = 'MULTIPLE' | * This check looks for null AEACNOT[1/2] when AEACNOTH = 'MULTIPLE', which indicates a possible SDTMv mapping issue * NOTE: not all ongoing studies are adopting this approach for AE resolution and this may not be appropriate to query | AE | Cross TA | Low |
3 | check_ae_aeacnoth_ds_disctx | Check for DS record indicating study discon when AE.AEACNOTx indicates study discon | * This code checks that when a patient has an AE with AEACNOTx = "SUBJECT DISCONTINUED FROM STUDY" (x = "H", "1", "2", ...) then there should also be a record in DS where DS.DSSCAT = "STUDY COMPLETION/EARLY DISCONTINUATION" and DS.DSDECOD != "COMPLETED". | AE, DS | Cross TA | Low |
4 | check_ae_aeacnoth_ds_stddisc_covid | Check patient(s) with COVID-related AEs leading to Study Discon, but no corresponding Study Discon recs in DS | * This check identifies COVID AE records with AEACNOT[H/n] indicated as leading to Study Discontinuation without a Study Discon record in DS * NOTE: COVID-19 AEs identified based on preferred terms from MedDRA v27.0 COVID-19 SMQ (Narrow) or earlier identified version based on TS | AE, DS | Covid-19 | Low |
5 | check_ae_aedecod | Check for AEs with missing Dictionary Derived Term | * This check looks for AEs with missing Dictionary Derived Term (AEDECOD) | AE | Cross TA | High |
6 | check_ae_aedthdtc_aesdth | Check for AEs with death date but AE death indicator not equal to 'Y' | * This check looks for AEs with death date (AEDTHDTC) populated but AE death indicator (AESDTH) != "Y" | AE | Cross TA | High |
7 | check_ae_aedthdtc_ds_death | Check patient(s) with "DEATH" in DSDECOD and string "ADVERSE EVENT" in DSTERM also with death date in AE | * This check identifies DS records with DSDECOD including the string "DEATH" and DSTERM including the string "ADVERSE EVENT" * who do not have an AE record with non-missing AEDTHDTC * This check logic is applicable to older, legacy studies that mapped DSTERM = 'DEATH DUE TO ADVERSE EVENT' rather than newer studies * using DSTERM = 'DEATH DUE TO [adverse event]' (e.g., "DEATH DUE TO INFLUENZA") | AE, DS | Cross TA | High |
8 | check_ae_aelat | OPHTHALMOLOGY: Check for missing laterality of eye-related AE | * This check identifies AE records where AELAT is missing but AESOC contains the string "EYE" * Laterality for eye-related AEs is expected to be reported | AE | Ophthalmology | High |
9 | check_ae_aeout | Check for AE consistency between death date and AE outcome | * This check looks for AEs with Death date(AEDTHDTC) but outcome (AEOUT) is not FATAL and conversely AEs with no death date (AEDTHDTC) but outcome (AEOUT) is fatal | AE | Cross TA | High |
10 | check_ae_aeout_aeendtc_aedthdtc | Check for fatal AEs with inconsistent or missing AE resolution date | * This check looks for AEs with fatal outcome (AEOUT = 'FATAL') and resolution date not populated or not equal to AE death date * NOTE: not all ongoing studies are adopting this approach for AE resolution and this may not be appropriate to query | AE | Cross TA | High |
11 | check_ae_aeout_aeendtc_nonfatal | Check for non-fatal AEs with inconsistent or missing AE resolution date | * This check looks for AEs with non-fatal outcome and flags when resolution date (AEENDTC) populated but AEOUT includes * "UNKNOWN", "NOT RECOVERED/NOT RESOLVED", or "RECOVERING/RESOLVING" * --or-- when resolution date not populated but AEOUT includes "RECOVERED/RESOLVED" or "RECOVERED/RESOLVED WITH SEQUELAE" | AE | Cross TA | Medium |
12 | check_ae_aerel | Check for AEREL and corresponding AEREL[n] values | * This check identifies AEREL with null values * If AEREL[n] variables are included, the check assesses SDTMv mapping is as expected | AE | Cross TA | Medium |
13 | check_ae_aesdth_aedthdtc | Check for AEs with AE death indicator equal to 'Y' but no death date | * This check looks for AEs with AE death indicator (AESDTH) = "Y" but death date (AEDTHDTC) not populated | AE | Cross TA | High |
14 | check_ae_aestdtc_after_aeendtc | Check for AEs with start date after end date | * This check looks for AEs with AE start date (AESTDTC) after AE end date (AEENDTC) | AE | Cross TA | High |
15 | check_ae_aestdtc_after_dd | Check for AEs with start date after death date | * This check finds records with AE start date (AESTDTC) after death date * Earliest death date between DS and AE domains is used for comparisons * Queries should be generated to determine which is incorrect of death date or AE date * Incomplete dates with known year and month but unknown day are imputed to the first of the month | AE, DS | Cross TA | High |
16 | check_ae_aetoxgr | Patients with missing AE grade values | * Check for AE records have missing values for either AETOXGR or AESEV. If both variables exist it checks for records where both are missing. | AE | Cross TA | High |
17 | check_ae_death | Grade 5 AEs where other variables do not indicate death | * This check identifies grade 5 AEs that do not also have the following: * Outcome (AEOUT) marked "FATAL", death indicator (AESDTH) marked "Y", or death date (AEDTHDTC) populated | AE | Cross TA | High |
18 | check_ae_death_ds_discon | Check for patients with AE indicating death but no Study Discontinuation form | * This check identifies instances where an AE indicates death (using AEDTHDTC, AESDTH, AEOUT, and/or AETOXGR if it exists) * and makes sure that those patients also have a Study Discontinuation form in the DS domain | AE, DS | Cross TA | High |
19 | check_ae_ds_partial_death_dates | Check for partial death dates | * This check looks for partial death dates in discon forms and in the AE form
* It looks for lengths <10 for DS.DSSTDTC where DS.DSDECOD="DEATH" as well as for AE.AEDTHDTC * Partial death dates should be queried | AE, DS | Cross TA | High |
20 | check_ae_dup | Duplicate AE records | * This check looks for duplicate AEs by the SDTMv variables listed below: * USUBJID, AETERM, AEDECOD, AESTDTC, AEENDTC, AELAT (if applicable), AEMODIFY (if applicable), AETOXGR -or- AESEV | AE | Cross TA | High |
21 | check_ae_fatal | Check for death variable consistency when AEOUT=="FATAL" | * This check looks for consistency in AE death variables AESDTH,AEDTHDTC, and AETOXGR (if applicable)
* when outcome (AEOUT) indicates 'FATAL' | AE | Cross TA | High |
22 | check_ae_withdr_ds_discon | Check for AE drug withdrawn but no DS treatment discontinuation record | * This check identifies patients with AEACN = 'DRUG WITHDRAWN' and missing a DS treatment discontinuation record * This check will run only for single-agent studies based on TS in which there is only one treatment discontinuation form expected in DS * and AEACN would not have the value = 'MULTIPLE' | AE, DS, TS | Cross TA | Medium |
23 | check_ce_missing_month | Check for "---" in clinical events dates | * This check looks for the string "---" in clinical events dates, e.g. 2010---01 * The presence of this string indicates that year and day are known, but month is not * While this is possible, it might be more likely that month was accidentally input as day * These values should be queried | CE | Cross TA | Low |
24 | check_cm_cmdecod | Check for concomitant medications with missing standardized medication names (CMDECOD) | * This check looks for conmeds with missing standardized medication names (CMDECOD) * Only records where CM.CMCAT = "CONCOMITANT MEDICATIONS" are checked | CM | Cross TA | Low |
25 | check_cm_cmindc | Check for CM records with prophylactic indication but prophylaxis checkbox unchecked | * This check identifies possible prophylactic conmeds (CM.CMINDC) that do not have the checkbox ticked (CM.CMPROPH) * This check ensures drugs are correctly coded as prophylactic, as some definitions of systemic drugs exclude prophylactic indications * especially corticosteroids * Teams may consider additional refinements to target records important for analysis | CM | Cross TA | Low |
26 | check_cm_cmlat | OPHTHALMOLOGY: Check for missing laterality of ocular conmed or laterality populated but route is not eye-related | * This check identifies Concomitant Medications (CMCAT = 'CONCOMITANT MEDICATION') where * the medication is eye-related (i.e., CMROUTE = 'INTRAVITREAL', 'OPHTHALMIC', etc.) but CMLAT is not populated --or-- * CMLAT reported as LEFT/RIGHT/BILATERAL but CMROUTE is not eye-related (i.e., not INTRAVITREAL, OPHTHALMIC, TOPICAL, etc.) | CM | Ophthalmology | Low |
27 | check_cm_cmlat_prior_ocular | OPHTHALMOLOGY: Check for missing laterality of ocular conmed reported as prior ocular therapies | * This check identifies Prior Ocular Therapies and Treatment eCRF (CMCAT = "PRIOR OCULAR THERAPIES AND TREATMENTS") * reported with missing/inconsistent laterality (CMLAT) | CM | Ophthalmology | Low |
28 | check_cm_missing_month | Check for "---" in concomitant medication dates | * This check looks for the string "---" in conmed dates, e.g. 2010---01 * The presence of this string indicates that year and day are known, but month is not * While this is possible, it might be more likely that month was accidentally input as day * These values should be queried | CM | Cross TA | Low |
29 | check_dd_ae_aedthdtc_ds_dsstdtc | Check that AE death date matches DS death date | * If a patient has a death date populated in AE they should have a matching death date in DS
* If AE.AEDTHDT exists it should match DS.DSSTDTC for death records | AE, DS | Cross TA | High |
30 | check_dd_ae_aeout_aedthdtc | Check for AEs with 'FATAL' outcome but no AE death date or non-fatal outcome with AE death date | * This check looks for AEs with death date (AEDTHDTC) not populated when AE outcome (AEOUT) marked "FATAL" | AE | Cross TA | High |