start time infusion
Item
Actual time of start of infusion
datetime
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Time Relative to start of infusion
integer
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Code List
Time Relative to start of infusion
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C0200345 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
start of infusion
Item
Actual time of start of infusion
datetime
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Item
Time relative to start of infusion
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Time relative to start of infusion
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C0200345 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Date/time
Item
Date/time
datetime
C1264639 (UMLS CUI [1])
Did the volunteer complete the study?
Item
Did the volunteer complete the study?
boolean
C2348577 (UMLS CUI [1])
Item
If no, please complete the following
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
If no, please complete the following
CL Item
Significant adverse events (adverse events form must be completed) (3)
CL Item
Lack of subject compliance (4)
CL Item
Subject lost to follow-up (5)
CL Item
Protocol violation (specify below) (6)
CL Item
Concurrent disease (specify below) (7)
CL Item
Other reason (specify below) (8)
Reason for withdrawal
Item
Reason for withdrawal-Details
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
When did the volunteer last take any study medication
Item
When did the volunteer last take any study medication?
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
all Adverse Event forms are up to date and complete
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Concominant Medication form is up to date
Item
Check that the Concominant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
all pages are signed (thus indicating completion) and dated
Item
Check that all pages are signed (thus indicating completion) and dated
boolean
C1283174 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
laboratory results are included
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Recorder's initials
Item
Recorder's initials
text
C2986440 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Study director
Item
Study director
text
C0025081 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Investigator-take full responsibility
Item
I.........(the investigator) take full responsibility for the pages completed in this book.
text
C0678341 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
Study Director
Item
Study Director
text
C0025081 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Freq/day
Item
Freq/day
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date and Time
Item
Start Date and Time
datetime
C0808070 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Date and Time
Item
End Date and Time
datetime
C0806020 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Continuing at the end of the study
Item
Continuing at the end of the study
boolean
C1553904 (UMLS CUI [1])
undefined item
Item
If no concominant medication is taken during the study, please select
boolean
C2347852 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])