Described below are cases of minor protocol non-compliance (committed by the study team) that generally do not need to be reported to the IRB to the extent that the event does not adversely affect subject safety, rights, or welfare, decrease potential benefits, or compromise data integrity.

This guidance is specific to unintended events that have already occurred and NOT to intended exceptions or deviations from the protocol, such as exceptions made to eligibility criteria for a single patient. Intended exceptions or deviations must be submitted to and reviewed by the IRB as a change of protocol prior to implementation unless necessary to eliminate an apparent immediate hazard to subjects (see corresponding section). See the Reportable Events examples table for examples of common deviations that do not require report to the IRB.

In order to be considered protocol non-compliance that does not require reporting to the IRB, the event must meet ALL of the following criteria:

• The event did not affect nor did it have the potential to affect the subject’s rights, safety or welfare*;
• The event did not result in a change to the participant’s clinical or emotional condition or status;
• The event did not affect the integrity, accuracy and/or reliability of the research data; and
• The event did not result from willful or knowing misconduct on the part of the study team.

*All study drug dosing errors (under- or over-dosing) and any events related to failure to obtain valid informed consent require reporting to the IRB.

A study team member not listed on the IRB application or whose role is not accurately reflected on the Study Team Roles page does not require reporting if ALL of the following are true:

• The study team member is internal to the UW (e.g. a UW-Madison/UWHC employee);
• The study team member has completed all required human subjects/GCP/HIPAA trainings and none are expired;
• The study team member has no financial conflicts of interest related to the study;
• The study team member has the appropriate expertise and training to conduct study
  procedures.

If the event meets the criteria above, the event does not require reporting to the IRB, but should still be documented in the study records.

If the study team has multiple (i.e., two or more) occurrences of the same kind of protocol non-compliance that is not otherwise reportable to the IRB (e.g., missed questionnaire, sample collection), please consult with the IRB Office to determine whether reporting is required.