SS P08 Outliers/Shifts White Paper

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White Paper Title and Lead

Title = Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal – With a Focus on Vitals, ECGs, and Labs in Phase 2-4 Clinical Trials and Integrated Summary Documents
Lead = Wei Wang


Draft 3 of the white paper is out for broad review. Link to Draft White Paper. Comments are due 01 December 2014. We encourage anyone to participate in this review, including statisticians, medical, medical writing. There are three ways in which you can provide your comments:

  1. Enter your comments in Agilewords (If you do not have an account with Agilewords, you need to apply for one - it is free). Link to Agilewords Version of the White Paper
  2. Enter your comments in the Discussion tab on this wiki page
  3. Provide comments to Wei Wang via email (

Reusable code for several tables and figures from the draft white paper is available in the Script Repository.

04 December 2014 Note: The review perod has been extended to 16 January 2015. Thank you to those who have already provided comments. Receiving comments before 01 December 2014 was helpful so that we can start working on the update! While we are working on the update, we are open to receiving additional comments before 16 January 2015.


Target February 2015 for a final white paper.


The draft paper OLD Outliers and Shifts Draft was available for review by 28 February 2014. Old Agilewords link: Agilewords

Several topics were discussed during the PhUSE CSS March 2014 Meeting: See SS P08 18March2014 Standard Scripts Project 08 Meeting for meeting minutes.

Version 2 Considerations

  • Mention that hepatic has its own white paper
  • Develop recommendations for shift to high and shift to low when a reference limit changes within an individual patient over time (eg, jumps to a new age group). It's possible that a patient has the exact value at baseline and postbaseline but show up as shifting to high or low. Could also miss a shift if the programming logic first takes min or max and then determines low/normal/high. Option 1-Use the limit from when the patient enters for analysis purposes. Option 2- Underlying logic should look for high or low during postbaseline, not first take min/max.

Category Identification

Last revised by MaryNilsson,04/4/2018