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Outstanding Issues 

  • The standard SDTM uses the term study treatment for several variables ( AEREL, AEACN. Should this be changes to study product (or another term).  

This is an example of a CRF used to collect all adverse experiences that occurred after informed consent is obtained. Adverse experiences were collect using free-text.  This CRF was designed to allow the sponsor to use either AEENRF or AEENRTPT to represent an event that was ongoing. This SDTM dataset used MHENRTPT. More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables


Indicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF.Were any adverse events experienced?
AEYN Not Submitted
<NY codelist>
AECAT
Hidden/pre-populated
Sponsor Defined
AESCAT
Hidden/pre-populated
Sponsor Defined
If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.
AESPID
_______
Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom.
AETERM
_________________
Record the start date of the AE using this format (DD-MON-YYYY).
AESTDAT AESTDTC
_ _ / _ _ _ / _ _ _ _
Indicate if the adverse event has not resolved at the time of data collection; leave the End Date blank.Is the adverse event ongoing?
AEONGO AEENRTPT/ AEENRF
<NY codelist>
Record the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.
AEENDAT AEENDTC
_ _ / _ _ _ / _ _ _ _
The reporting physician/healthcare professional will assess the severity of the event using sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported AE to similar type events observed in clinical practice. Severity is not equivalent to seriousness.Severity
AESEV
<AESEV codelist>
Assess if an adverse event should be classified as serious based on the criteria defined in the protocol.Was the adverse event serious?
AESER
<NY codelist>
Record whether the serious adverse event resulted in death.Did the adverse event result in death?
AESDTH
<NY codelist>
Record the date of death.
DTHDAT DM.DTHDTC
_ _ / _ _ _ / _ _ _ _
Record whether the serious adverse event is life-threatening.Life Threatening
AESLIFE
<NY codelist>
Record whether the serious adverse event resulted in an initial or prolonged hospitalization.Hospitalization (initial or prolonged)
AESHOSP
<NY codelist>
Record whether the serious adverse event resulted in a persistent or significant disability or incapacity.Disability or Permanent Damage
AESDISAB
<NY codelist>
Record whether the serious adverse event was associated with congenital anomaly or birth defect.Congenital Anomaly or Birth Defect
AESCONG
<NY codelist>
Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.Needs Intervention to Prevent Impairment
AESINTV SUPPAE.QVAL
<NY codelist>
Record whether the serious adverse event is an important medical event, which may be defined in the protocol or in the investigator brochure.Other Serious (Important Medical Events)
AESMIE
<NY codelist>
Indicate if the cause of the adverse event was related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).Relationship to Study Treatment
AEREL
Record changes made to the study treatment resulting from the adverse event.Action Taken with Study Treatment
AEACN
<ACN codelist>
Record the appropriate outcome of the event in relation to the subject's status.Outcome
AEOUT
<OUT codelist>
Record any action taken with a device as the result of the adverse event. The device may or may not be a device under study.Action Taken with Device
AEACNDEV
<DEACNDEV codelist>
Relationship of Event to DeviceRelationship of Event to Device
AERLDEV
OrderQuestion TextPromptCRF Completion InstructionsTypeCDASH VariableSDTMIG Target VariableSDTMIG Target MappingControlled Terminology CodeList NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1Were any adverse events experienced?Any Adverse EventsIndicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF.TextAEYNN/A
(NY)Yes; No



2What is the category of the adverse event?Adverse Event CategoryRecord the adverse event category, if not pre-printed on the CRF.TextAECATAECAT


Sponsor Defined

Yes
3What is the subcategory of the adverse event?Adverse Event SubcategoryRecord the adverse event subcategory, if not pre-printed on the CRF.TextAESCATAESCAT


Sponsor Defined

Yes
4What is the adverse event identifier?AE NumberIf collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.IntegerAESPIDAESPID



prompt

5What is the adverse event term?Adverse EventRecord only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom.TextAETERMAETERM






6What is the adverse event start date?Start DateRecord the start date of the AE using this format (DD-MON-YYYY).DateAESTDATAESTDTC



prompt

7Is the adverse event ongoing?OngoingIndicate if the adverse event has not resolved at the time of data collection; leave the End Date blank.TextAEONGOAEENRTPT; AEENRFAEENRTPT/ AEENRF(NY)Yes

checkbox
8What was the adverse event end date?End DateRecord the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.dateAEENDATAEENDTC



prompt

9What is the severity of the adverse event?SeverityThe reporting physician/healthcare professional will assess the severity of the event using sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported AE to similar type events observed in clinical practice. Severity is not equivalent to seriousness.TextAESEVAESEV
(AESEV)MILD; MODERATE; SEVERE
prompt

10Was the adverse event serious?SeriousAssess if an adverse event should be classified as serious based on the criteria defined in the protocol.TextAESERAESER
(NY)Yes; No



11Did the adverse event result in death?DeathRecord whether the serious adverse event resulted in death.TextAESDTHAESDTH
(NY)Yes; No



12What [is/was] the subject’s date of death?Death DateRecord the date of death.dateDTHDATDM.DTHDTC



prompt

13Was the adverse event life-threatening?Life ThreateningRecord whether the serious adverse event is life-threatening.TextAESLIFEAESLIFE
(NY)Yes; No
prompt

14Did the adverse event result in initial or prolonged hospitalization for the subject?Hospitalization (initial or prolonged)Record whether the serious adverse event resulted in an initial or prolonged hospitalization.TextAESHOSPAESHOSP
(NY)Yes; No
prompt

15Did the adverse event result in disability or permanent damage?Disability or Permanent DamageRecord whether the serious adverse event resulted in a persistent or significant disability or incapacity.TextAESDISABAESDISAB
(NY)Yes; No
prompt

16Was the adverse event associated with a congenital anomaly or birth defect?Congenital Anomaly or Birth DefectRecord whether the serious adverse event was associated with congenital anomaly or birth defect.TextAESCONGAESCONG
(NY)Yes; No
prompt

17Did the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product?Needs Intervention to Prevent ImpairmentRecord whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.TextAESINTVSUPPAE.QVAL
(NY)Yes; No
prompt

18Was the adverse event a medically important event not covered by other "serious" criteria?Other Serious (Important Medical Events)Record whether the serious adverse event is an important medical event, which may be defined in the protocol or in the investigator brochure.TextAESMIEAESMIE
(NY)Yes; No
prompt

19Was this adverse event related to study treatment?Relationship to Study TreatmentIndicate if the cause of the adverse event was related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).TextAERELAEREL

NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED
prompt

20What action was taken with the study treatment?Action Taken with Study TreatmentRecord changes made to the study treatment resulting from the adverse event.TextAEACNAEACN
(ACN)DRUG WITHDRAWN; DOSE REDUCED; DOSE INCREASED; DOSE NOT CHANGED; UNKNOWN; NOT APPLICABLE
prompt

21What is the outcome of this adverse event?OutcomeRecord the appropriate outcome of the event in relation to the subject's status.TextAEOUTAEOUT
(OUT)RECOVERING / RESOLVING; NOT RECOVERED / NOT RESOLVED; RECOVERED / RESOLVED; RECOVERED / RESOLVED WITH SEQUELAE; FATAL  
prompt

22What is the action taken with a device?Action Taken with DeviceRecord any action taken with a device as the result of the adverse event. The device may or may not be a device under study.TextAEACNDEVAEACNDEV
(DEACNDEV)CALIBRATION;REMOVAL; REPROGRAMMING 


prompt

23Was this adverse event related to a device? Relationship of Event to DeviceRelationship of Event to DeviceTextAERLDEVAERLDEV

Not Related; Unlikely; Possible; Probable; 
Prompt

This SDTM dataset illustrates data collected on the example AE CRF above,  AEs were coded using MedDRA, and the sponsor’s procedures include the possibility of modifying the reported term to aid in coding. The CRF was structured so that seriousness category variables (e.g., AESDTH, AESHOSP) were checked only when AESER is answered “Y.” In this study, the study reference period started at the start of study treatment. Three AEs were reported for this subject. This SDTM dataset used AEENRF to represent Ongoing events. . More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables

Rows 1-2:Show examples of modifying the reported term for coding purposes, with the modified term in AEMODIFY. These adverse events were not serious, so the seriousness criteria variables are null. Note that for the event in row 2, AESTDY = "1". Day 1 was the day treatment started; the AE start and end times, as well as dates, were collected to allow comparison of the AE timing to the start of treatment.
Row 3:Shows an example of the overall seriousness question AESER answered with "Y" and the relevant corresponding seriousness category variables (AESHOSP and AESLIFE) answered "Y". The other seriousness category variables are left blank. This row also shows AEENRF being populated because the AE was marked as “Continuing” as of the end of the study reference period for the subject (see Section 4.4.7, Relative Timing Variables).

ae.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDAESEQAETERMAEMODIFYAEDECODAEBODSYSAESEVAESERAEACNAERELAEOUTAESCONGAESDISABAESDTHAESHOSPAESLIFEAESMIEEPOCHAESTDTCAEENDTCAESTDYAEENDYAEENRF
1ABC123AE1231011POUNDING HEADACHEHEADACHEHeadacheNervous system disordersSEVERENNOT APPLICABLEDEFINITELY NOT RELATEDRECOVERED/RESOLVED





SCREENING2005-10-122005-10-12-1-1
2ABC123AE1231012BACK PAIN FOR 6 HOURSBACK PAINBack painMusculoskeletal and connective tissue disordersMODERATENDOSE REDUCEDPROBABLY RELATEDRECOVERED/RESOLVED





TREATMENT2005-10-13T13:052005-10-13T19:0011
3ABC123AE1231013PULMONARY EMBOLISM
Pulmonary embolismVascular disordersMODERATEYDOSE REDUCEDPROBABLY NOT RELATEDRECOVERING/RESOLVING


YY
TREATMENT2005-10-21
9
AFTER
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