
308 ◾ Appendix D: Clinical Trial Process Specification
Table D.2 Clinical Trial Process Measurement
Time Number of
days waiting
for study to
be approved
Number of
patients being
recruited for
each day
Enrollment
rate per
site per
month
Average time
spent on site per
visit
Average
time spent
per test
Average
time spent
on audited
report
Time of
waiting for
trial to be
approved
Quality Number of
not approved
studies or
number of
change
protocols
Number of
disqualified
recruited
patients
Percent of
patients
failed to
register
Number of
patient withdraws
and number of
data collected
outside of cycle
time
Number of
failure tests
Number of
failure
reports
Number ...