Has informed consent been obtained for Pharmacogenetic Research?
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
If informed consent has been obtained for Pharmacogenetic Research, record date
Item
If informed consent has been obtained for Pharmacogenetic Research, record date
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Code List
If informed consent has not been obtained for Pharmacogenetic Research, check one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
Item
If other reason for informed consent has not been obtained for Pharmacogenetic Research, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Has a blood sample been collected for Pharmacogenetic Research?
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
If a blood sample has been collected for Pharmacogenetic Research, record date
Item
If a blood sample has been collected for Pharmacogenetic Research, record date
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has this subject withdrawn consent for Pharmacogenetic Research?
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check one reason
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Code List
If a request has been made for sample destruction, check one reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
If other reason for request for sample destruction, specify
Item
If other reason for request for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C2826257 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
SINGLE Dose/ Unit
Item
SINGLE Dose/ Unit
text
C1960417 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Code List
Medication Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
subcutaneous (SC)
Medication Indication
Item
Medication Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Duration of Therapy
Item
Duration of Therapy
text
C0444917 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing at end of study?
Item
Medication continuing at end of study?
boolean
C1553904 (UMLS CUI [1])
Baseline Sign/ Symptom
Item
Baseline Sign/ Symptom
text
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Signs/ Symptoms Onset Date and Time
Item
Signs/ Symptoms Onset Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Signs/ Symptoms End Date and Time
Item
Signs/ Symptoms End Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Signs/ Symptoms Outcome
integer
C0037088 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Code List
Signs/ Symptoms Outcome
Item
Signs/ Symptoms Event Course
integer
C0037088 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
Code List
Signs/ Symptoms Event Course
If intermittent Course, record number of episodes
Item
If intermittent Course, record number of episodes
integer
C0750729 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Item
Signs/ Symmptoms Intensity
integer
C0518690 (UMLS CUI [1])
Code List
Signs/ Symmptoms Intensity
Item
Relationship to study procedures performed prior to randomisation
integer
C2700391 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Code List
Relationship to study procedures performed prior to randomisation
Signs/ Symptoms Corrective Therapy
Item
Signs/ Symptoms Corrective Therapy
boolean
C0037088 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was subject withdrawn due to this event?
Item
Was subject withdrawn due to this event?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])