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114
NORIG SOP Part I: Clinical Center Operations
7.9.
•
7. Forms management
Missing data
If a data item is missing and cannot be obtained when the form is completed or reviewed,
write the appropriate code in the first left hand space of the empty data field:
?
=
d
n
m
r
=
=
=
=
data temporarily missing or inconsistent; to be collected or resolved in the near
future; items keyed with a ? will need to be followed up on and resolved
patient does not know the answer
not applicable in this situation
data missing
patient refused
•
When using any of the above codes, the entire data field does not need to be filled with the
code (e.g., a missing height would be completed as m
. ).
•
If data are missing on the form, an explanation for the missing values should be written on
the form and keyed to the database in the General Comments section of the keying.
•
It is very important to keep the number of missing data items at a minimum, especially at
baseline, since many future papers will depend on having a good set of baseline
values. If an item is missing at the time the form is filled out, but is expected to be
collected in the near future, use a ‘?’ rather than the ‘m’ code for the item on the form.
The ‘m’ missing code is for items that are truly missing. Coordinators are discouraged
from using the ‘m’ code as a way to get through the data entry checks and enroll a
patient; the screening windows should be broad enough to allow you to collect all data
within the allotted time window. Also, if the data system will not accept a value
because it is out of range, please contact the DCC, so we can make a determination as
to whether the range checks need to be adjusted. In the meantime, use a ‘?’ rather than
an ‘m’ on the form. If there is a valid reason that a required baseline laboratory value
is missing, please fax the Laboratory Results (LR) form to the DCC along with the
reason for the missing value.
GPCRC/NORIG/NORIG_SOPI\M anall_47
10:39 am Thursday, August 18, 2011/klc
NORIG SOP – Part I
Confidential, not for citation
M issing