Study Days THE ISSUE: There is confusion around the definition of STUDY DAY and the date assigned by the computer in the eCRF. WHO DOES THIS IMPACT? Sites who have flow sheets that DO NOT run midnight- to-midnight. The confusion arises when there is an ICU admission time after midnight but before the end of the flow sheet.

Study Day 1 Study Day 1 is the day & time of ICU admission to the END of your site’s flow sheet. EXAMPLE: Flow sheet: 07:00 to 06:59 ICU admit: 05:30 The computer assigns Study Day 1: 08-Jan-08 This means you collect data from 08-Jan-08 at 05:30 UNTIL 08-Jan-08 at 06:59 Note: Study Day 1 is only 1 hr 59 min.

STUDY DAY 1 08-Jan-08 at 05:30 UNTIL 08-Jan-08 at 06:59 ICU admit: 05:30

Study Day 2, etc. Subsequent study days are represented by the 24 hours period according to your flow sheet. The study day date assigned by the computer is the date at the end of your flow sheet EXAMPLE: Flow sheet: 07:00 to 06:59 ICU admit: 05:30 Day 2: 08-Jan-08 at 07:00 UNTIL 09-Jan-08 at 06:59 Day 3: 09-Jan-08 at 07:00 UNTIL 10-Jan-08 at 06:59 Day 4: 10-Jan-08 at 07:00 UNTIL 11-Jan-08 at 06:59 Day 5: 11-Jan-08 at 07:00 UNTIL 12-Jan-08 at 06:59 ……etc

Study Day 2 = 09/Jan/2008 You collect data from 07:00 until 06:59 Study Day 3 = 10/Jan/2008 You collect data from 07:00 until 06:59 Study Day 4 = 11/Jan/2008 You collect data from 07:00 until 06:59