Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Clinical trial participant
Item
Subject
text
C1997894 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Follow-up, Contact with, Study subject
Item
Subject contacted for follow-up?
boolean
C1522577 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Study End Date, Patient withdrawn from trial, Date in time
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol Deviation (4)
CL Item
Subject reached protocol defined stopping criteria (5)
CL Item
Study closed/terminated (6)
CL Item
Lost to Follow-up (7)
CL Item
Withdrew consent (8)
CL Item
Investigator discretion, specify (9)
Experimental drug, Double-Blind Method, Start Date
Item
Start Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Experimental drug, Double-Blind Method, End Date
Item
Stop Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Pharmacogenetics, Consent Withdrawn
Item
Has subject withdrawn consent for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Pharmacogenetics, Consent Withdrawn, Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetics, Blood Specimen, Destruction, Request
Item
Has a request been made for sample destruction?
boolean
C0031325 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C0031325 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C3146298 (UMLS CUI [1,5])
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Investigator Signature
Item
Is this casebook ready to sign?
boolean
C2346576 (UMLS CUI [1])
Pregnant during the study
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])