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Xformpusher
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target ValueSDTMIG Target MappingControlled Terminology Code List NameCRF Implementation NotesPermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
DSCAT1What was the category of the disposition?Disposition CategoryIf collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.TextDSCATDSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED"(DSCAT)Refer to the SDTMIG for guidelines for assigning DSCAT, DSTERM, and DSDECOD for events considered protocol milestones.
PROTOCOL MILESTONEprompt
Yes
DSSTDAT2What was the informed consent date?Informed Consent DateRecord the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY).DateDSSTDTC




qtext

DSSTTIM3What was the informed consent time?Informed Consent TimeRecord the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions.TimeDSSTDTC




qtext




Xformpusher
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NameCRF Implementation NotesPermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
DSCAT1What was the category of the disposition?Disposition CategoryIf collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.TextDSCAT
(DSCAT)

DISPOSITION EVENTprompt
Yes
DSDECOD2What was the subject's status?StatusDocument the subject's status at study completion. If the subject discontinued prematurely, record the primary reason for discontinuation.TextDSDECOD
(NCOMPLT)The Controlled Terminology (NCOMPLT) is focused on disposition events, and is used when DSCAT is "DISPOSITION EVENT". COMPLETED; ADVERSE EVENT; DEATH; DISEASE RELAPSE; LACK OF EFFICACY; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY DRUG; PHYSICIAN DECISION; PREGNANCY; PROGRESSIVE DISEASE; PROTOCOL DEVIATION; RECOVERY; SITE TERMINATED BY SPONSOR; STUDY TERMINATED BY SPONSOR; TECHNICAL PROBLEMS; WITHDRAWAL BY PARENT/GUARDIAN; WITHDRAWAL BY SUBJECT

radio
DSTERM3If adverse event, specifySpecifyIf Adverse Event is selected from the Status list, provide the verbatim reason.TextDSTERM

If DSTERM was collected as an adverse event, Specify", populate the SDTMIG variable DSTERM with the free text and populate DSDECOD with the standardized text from (NCOMPLT).

prompt

DSSTDAT4What was the study completion/discontinuation date?Study Completion/Discontinuation Date

Record the date that the subject completed the study using this format (DD-MON-YYYY). If the subject did not complete the study, record the date that the subject discontinued.

DateDSSTDTC







DSSTTIM5What was the study completion/discontinuation time?Study Completion/Discontinuation TimeRecord the time (as complete as possible) that the subject completed the study. If the subject did not complete the study, record the time (as complete as possible) that the subject discontinued.TimeDSSTDTC







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