ds CRFs

Example Case Report Forms for DS domain

Form: Consent Withdrawls

Question	Response
Type of Consent	Study Informed Consent
Date of Consent Withdrawal	DS.DSSTDTC

Form: Screen Fail Status

Question	Response
Is the subject a screen fa	NO YES
Primary Screen Failure Rea	ADVERSE EVENT LOST TO FOLLOW-UP WITHDRAWAL BY SUBJECT OTHER "DS.EPOCH=""SCREENING"" DS.DSSCAT=""SCREEN FAILURE"" DS.DSCAT=""DISPOSITION EVENT"" DS.DSDECOD DS.DSTERM when response is not 'OTHER'"
If Primary Screen Failure	DS.DSTERM when DS.DSDECOD='OTHER'

Form: Enrollment

Question	Response
Date Consent Form Signed	"DM.RFICDTC\|DS.DSSTDTC when DS.DSDECOD=""INFORMED CONSENT OBTAINED"""
Consent Version Number	"SUPPDS.QNAM.ICVERS when DS.DSDECOD=""INFORMED CONSENT OBTAINED"""
Protocol Version	"SUPPDS.QNAM.PRTVERS when DS.DSDECOD=""INFORMED CONSENT OBTAINED"""
Date of Enrollment	"DS.DSSTDTC when DS.DSDECOD=""ENROLLED"""
Date of Randomization	"DS.DSSTDTC when DS.DSDECOD=""RANDOMIZED"""
Randomization number	"DS.DSREFID when DS.DSDECOD=""RANDOMIZED"""

Form: End of Treatment

Question	Response
Did the subject complete t	Yes Not submitted
Did the subject complete t	No
Date of completion/discont	DS.DSSTDTC
Primary reason for ending	Completed Decision by Sponsor Lost to follow-up Death Adverse event Subject Request DS.DSTERM

Form: End of Study

Question	Response
Did the subject complete t	Yes No Not submitted
Date of completion/discont	DS.DSSTDTC
Primary reason for ending	Completed Decision by Sponsor Lost to follow-up Death Adverse event Subject Request Other "DS.DSCAT=""DISPOSITION EVENT"" DS.DSSCAT=""END OF STUDY"" DS.DSTERM DS.DSDECOD"
If other, specify