Local Laboratory - haematology
day month year
date
00:00-23:59
time
Haematology test
integer
If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).
text
Local Laboratory - clinical chemistry
day month year
date
00:00-23:59
time
Note: FSH and LH are for females subjects only. FSH and LH are only for screening and unscheduled.
integer
If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.
text
Urine dipstick test
day month year
date
00:00-23:59
time
Result of dipstick
text
Urinalysis - local
day month year
date
00:00-23:59
time
Urinalysis Test
integer
If the laboratory results are not available to report or if a lab error occurred, enter "NR" (the abbreviation for ’No Result’). If the laboratory test(s) need to be repeated, record results in the unscheduled form.
text
Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.
text
Urinalysis (Microscopy) Test
integer
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
text