Protocol Deviation Number
Item
Protocol Deviation Number
integer
C1705236 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Please select Study Day
integer
C2826182 (UMLS CUI [1])
Code List
Please select Study Day
CL Item
through Day 14 (10)
CL Item
through Day 28 (11)
CL Item
through Day 33 (12)
CL Item
through Day 56 (13)
CL Item
through Day 84 (14)
CL Item
Early Withdrawl (15)
Item
Protocol deviation
text
C1705236 (UMLS CUI [1])
Code List
Protocol deviation
CL Item
Eligibility Criteria not met (1)
CL Item
Not withdrawn after developing withdrawal critieria (2)
CL Item
Informed consent procedure (7)
CL Item
Prohibited Medication or Device (8)
CL Item
Administer/Dispense Study Medication (9)
CL Item
Failure to report SAE, Pregnancy or liver function abnormalities per protocol (10)
CL Item
Study Treatment Supply Procedures (12)
CL Item
Biological Specimen Sample Procedures (13)
CL Item
Assessment Procedures (14)
CL Item
Equipment Procedures (16)
CL Item
Randomization Procedures (17)
CL Item
Other protocol deviation, specify (OT)
Specify other protocol deviation
Item
Specify other protocol deviation
text
C0205394 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Protocol deviation: Visit window: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Code List
Protocol deviation: Visit window: Please select sub-category
CL Item
Visit not conducted per visit schedule (6a)
CL Item
Visit not within visit window (6b)
CL Item
Missed visit (6c)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Visit
Item
Specify other Protocol Deviation in Visit Window category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item
Protocol Deviation in Administer/Dispense Study Medication category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1705236 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
Code List
Protocol Deviation in Administer/Dispense Study Medication category: Please select sub-category
CL Item
Subject received wrong treatment (9a)
CL Item
Subject received incorrect dose (9b)
CL Item
Treatment not prepared or administered per protocol (9c)
CL Item
Subject received expired treatment (9d)
CL Item
Subject received treatment not stored as per protocol (9e)
CL Item
Subject not compliant (9f)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Administration/Dispensing Study Medication
Item
Specify other Protocol Deviation in Administration/Dispensing Study Medication category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C1880359 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C1521902 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1705236 (UMLS CUI [2,3])
C1533734 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
Item
Protocol Deviation in Study Treatment Supply Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0243163 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Protocol Deviation in Study Treatment Supply Procedures category: Please select sub-category
CL Item
Study treatment accountability not performed as per protocol (12a)
CL Item
Study treatment disposal not performed as per protocol (12b)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Study Treatment Supply
Item
Specify other Protocol Deviation in Study Treatment Supply Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0243163 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
Item
Protocol Deviation in Biological Specimen Sample Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
Code List
Protocol Deviation in Biological Specimen Sample Procedures category: Please select sub-category
CL Item
Biological Specimen Sample Collection not performed per protocol (13a)
CL Item
Biological Specimen Sample Labelling not performed per protocol (13b)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Biological Specimens
Item
Specify other Protocol Deviation in Biological Specimen Sample Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C2347026 (UMLS CUI [1,4])
Item
Protocol Deviation in Equipment Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0014672 (UMLS CUI [1,2])
Code List
Protocol Deviation in Equipment Procedures category: Please select sub-category
CL Item
Calibration or maintenance of equipment not performed as per protocol (16a)
CL Item
Equipment not functioning (16b)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Equipment
Item
Specify other Protocol Deviation in Equipment Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0014672 (UMLS CUI [1,4])
Item
Protocol Deviation in Randomization Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Code List
Protocol Deviation in Randomization Procedures category: Please select sub-category
CL Item
Subject not randomized per protocol (17a)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Randomization
Item
Specify other Protocol Deviation in Randomization Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,4])
Protocol deviation description
Item
Protocol deviation description
text
C1705236 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Date protocol deviation discovered
Item
Date protocol deviation identified
partialDate
C0011008 (UMLS CUI [1,1])
C1880355 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
Actions taken due to Protocol Deviation
Item
Actions taken
text
C1705236 (UMLS CUI [1,1])
C1547656 (UMLS CUI [1,2])
Item
Escalated to GSK Physician for Medical Oversight?
text
C1705236 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C1283169 (UMLS CUI [1,4])
Code List
Escalated to GSK Physician for Medical Oversight?