Non-Compliance Form

NON-COMPLIANCE FORM

PI Name: IRB #: Current UCHC Enrollment: Study Drug or Intervention: Title (required only when report is submitted apart form continuation form): Events that may be considered non-compliance that occur within the control of the research team must be reported to the IRB Office within five business days of becoming aware of the event and at the time of continuing review. Non-compliance is defined as any action that is taken or occurs that is not in accordance with an IRB approved study, IRB policies or regulations or failure to follow the requirements and determinations of the IRB. Non-compliance may be minor (e.g. a participant is one day late for visit due to family emergency and there is no impact on the safety of the participant due to the late visit ) or it may be considered serious or continuing. Noncompliance is considered serious when it creates increased risks to subjects, adversely affects the rights and welfare of the subjects, or affects the scientific integrity of a study. Willful violations of IRB policies and /or Federal regulations including those pertaining to obtaining informed consent, reporting of adverse events, and disclosure to subjects of conflicts of interests and risks associated with a study are also considered serious noncompliance. The IRB will make the final determination as to what constitutes serious noncompliance. Noncompliance is considered to be continuing noncompliance when a pattern of non-compliance exists that if allowed to continue is likely to increase the risks to subjects, adversely affect the rights and welfare of subjects, or affect the scientific integrity of the study. It may involve the same mistake being made repeatedly within one study or across studies (e.g. a co-investigator on two of the PI’s approved studies fails to document subject consent) or the same mistake being made after a corrective plan has been issued to the investigator for previous findings of non-compliance. The IRB will make the final determination as to what constitutes continuing non-compliance. Complete the table below, deleting the example information prior to submission to the IRB. For reports that were previously filed with the IRB, indicate whether the determination of the IRB was serious non-compliance, continuing-non compliance, or non-reportable non-compliance (i.e. neither serious or continuing non-compliance). Tabbing out of the cell at the bottom right of the table will insert another row. Add any comments that you think will be helpful to the IRB (attachments are acceptable).

[DELETE THIS SENTENCE AND THE FOLLOWING EXAMPLE TEXT INFORMATION PRIOR TO SUBMITTING TO THE IRB]

Date of Description of Individual Reason Corrective Action Date Previously Comments/Outcomes Occurrence & Protocol Deviations Taken Reported to IRB & Subject ID IRB determinations Example: Subject 2 days late for follow- Subject canceled original None- not within NA – 1/12/04 up appt. scheduled for 1/10/04 appointment due to family control of the #324 emergency research team Example: Wrong dosage of IND Co-Investigator referred to PI held discussion 2/11/2004 Patient was given drug to 2/10/04 administered to subject wrong version of the protocol with investigator, old serious non- counteract overdose and #567 versions clearly compliance responded well without further marked as such and incident. IRB did not require kept apart from most any additional corrective action recent version. PI beyond that implemented by the will discuss all PI. . modifications with study personnel upon IRB approval.