1 / 5

Study Days

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.

vernon-wiggins
Download Presentation

Study Days

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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.

  2. 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: 08-Jan-08 @ 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.

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

  4. 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: 08-Jan-08 @ 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

  5. Study Day 2 = 09/Jan/2008 You collect data from 08/Jan/08 @ 07:00 until 09/Jan/08 @ 06:59 Study Day 3 = 10/Jan/2008 You collect data from 09/Jan/08 @ 07:00 until 10/Jan/08 @ 06:59 Study Day 4 = 11/Jan/2008 You collect data from 10/Jan/08 @ 07:00 until 11/Jan/08 @ 06:59

More Related