Informed Consent
Item
Has informed consent been obtained for PGx research?
boolean
C4084975 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Date of informed consent
Item
Date of informed consent
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If no informed consent specified pick a reason
integer
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If no informed consent specified pick a reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
Reason other specified
Item
Please specify the reason "other"
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Sample Collection
Item
Has a sample been collected for PGx research?
boolean
C0200345 (UMLS CUI [1,1])
C4084975 (UMLS CUI [1,2])
Date sample collected
Item
Date sample collected
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Withdrawal of consent
Item
Has subject withdrawn consent for PGx research?
boolean
C4084975 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Date consent withdrawn
Item
Date consent withdrawn
date
C4084975 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Sample Destruction
Item
Has a request been made for sample destruction?
boolean
C0686900 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
Item
Request for sample destruction reason
integer
C0686900 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Code List
Request for sample destruction reason
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Other reason specified
Item
Specify reason "other"
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Did the subject become pregnant during the study?
integer
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item
Did a female partner of the male subject become pregnant during the study?
integer
C0086287 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (3)
Treatment Status Blind Broken
Item
Was the treatment blind broken during the study?
boolean
C0150108 (UMLS CUI [1,1])
C0749659 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
Date and time blind broken
Item
Date and time blind broken
datetime
C0011008 (UMLS CUI [1,1])
C0150108 (UMLS CUI [1,2])
C0749659 (UMLS CUI [1,3])
C0443289 (UMLS CUI [1,4])
C0040223 (UMLS CUI [2,1])
C0150108 (UMLS CUI [2,2])
C0749659 (UMLS CUI [2,3])
C0443289 (UMLS CUI [2,4])
Item
Reason blind broken
integer
C0566251 (UMLS CUI [1,1])
C0150108 (UMLS CUI [1,2])
C0749659 (UMLS CUI [1,3])
C0443289 (UMLS CUI [1,4])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
Other reason specified
Item
Specify reason "other"
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C2348577 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Withdrawn
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate (2)
CL Item
Lost to follow-up (3)
CL Item
Protocol violation (4)
CL Item
Subject decided to withdraw from the study (5)
CL Item
Sponsor terminated study (6)
Reason other specified
Item
Reason other specified
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])