Chapter 55

Definition of Screen Failures and Withdrawals

Report the number of screen failures and withdrawals on the Site Continuing Review Reports according to the following definitions. WCG IRB acknowledges that the definitions for these terms vary across the industry, but please apply the following definitions when reporting to WCG IRB: 

  • Screen failure: Participant(s) removed from the study during the screening process because they did not meet all inclusion and exclusion criteria, or other requirements that must be met for research participation. Participant(s) who leave the study after randomization or assignment to study treatment should be counted as withdrawals rather than screen failures, even if the participant did not start the study treatment.
  • Withdrawal: Participant(s) are considered to have been withdrawn/discontinued from the research when the participant(s) either stopped participation or the research team stopped the participant’s participation early for reasons other than reaching a study endpoint. Do not count screen failures when reporting withdrawals.
  • Participant deaths: Because some protocols anticipate that a participant may pass away during the research / during long term follow-up, and include death as a possible endpoint, a participant who passes away may be counted among the completed participants on the report. If the protocol does not have death as a study endpoint, a participant who passes away would be considered a withdrawal (enter in the field for “How many subjects decided on their own to stop taking part in the research?”) 
    Therefore, there are two possible fields on the form where deceased participants may be part of the participant count:
    • “How many participants decided on their own to stop taking part in the research?” and
    • “How many participants did you remove from the research before reaching a study endpoint?”  

As long as the numbers are reported consistently from one form to the next, either category is acceptable to WCG IRB. (Note that the CRRF prompts the submitter to enter a reason whenever a number is entered for participants who stopped taking part in the research.)