Last Updated: 9/18/17

Non-Compliance with the Protocol, Board Requirements or Regulations Report Form

The UnityPoint Health Des Moines IRB requires all non-compliance issues related to research activity approved by the UPHDM IRB to be reported in writing to the IRB Office within 7 days of event notification/discovery of the event.

UPHDM IRB considers the following to be a non-compliance issue:

·  issues that have an adverse effect on the safety or welfare of study subject(s)

·  issues that have an adverse effect on the scientific integrity of the data collected or are related to a breach of confidentiality

·  deviations from the protocol

·  deviations from the board requirements

·  failure to adhere to federal, state, or local regulations.

The Principal Investigator (PI) must use his/her clinical judgment in determining which issues and or events rise to the level of non-compliance with the protocol, board requirements or regulations.

Non-Compliance with the Protocol (Previously Protocol Deviation/Violation)

Non-Compliance with the protocol is any variation from the approved study protocol, whether by omission or error, and also includes deviations for which the sponsor has provided a written waiver. Non-Compliance with the protocol is considered to have adverse effects on the safety or welfare of the study subjects(s), on the value of the data collected, or related to a breach of confidentiality, when it compromises the safety or confidentiality of the study subject or the scientific integrity of the study. Examples include but are not limited to:

·  Deviations from the inclusion/exclusion criteria that affect subject safety;

·  Omission of or delay in conducting safety monitoring procedures;

·  Incorrect administration of study products or errors in adherence to study procedures

·  Errors in obtaining informed consent.

Non-Compliance with Board Requirements

Non-Compliance with board requirements is any variation from requirements as listed in the approval letter, amendment letters, re-approval letters, or other IRB communications. Examples included but are not limited to:

·  Failure of team members to complete required IRB training regarding ethical principles in the protection of human subject research.

·  Failure to submit amendments for changes in the study information as presented in application (recruitment strategies, change in financial disclosures, published safety/benefit information, etc.).

·  Failure to submit required documents in the timeline requested.

Non-Compliance with Regulations

Non-Compliance with regulations is any variation from the federal, state, or local regulations regarding clinical research. It is the PI’s responsibility to know and follow all pertinent regulations. Examples include but are not limited to:

·  A failure of a physician to obtain the informed consent for administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner in PA. (45CFR46.116),

·  Failure to include all elements required in a research informed consent [(45CFR46.116(a); 21CFR50.25(a)]

·  Failure to comply with the regulations of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. A written authorization (“HIPAA Authorization”) is required from each study participant who will have PHI divulged to any third party.

Unanticipated Problems

Unanticipated problems involving risks to participants or others as problems that:

·  are unforeseen/unexpected

·  are related to the research

·  puts participants or others at increased risk of harm.

Potential Serious Non-Compliance

Serious noncompliance is noncompliance that adversely affects the rights and welfare of study participants or results in any untoward medical occurrence that meets the criteria of “serious” or significantly impacts the integrity of study data.

Serious is defined as side effects that may require hospitalization or may be irreversible, long-term, life-threatening, or fatal.

Continuing Non-Compliance

The definition of continuing noncompliance is a pattern that, if unaddressed, could jeopardize the rights and welfare of research participants or the integrity of the study data due to noncompliance with the protocol, Federal regulations, and/or the requirements of the IRB.

Any event that is not compliant with the protocol, board requirements, or the regulations, that is unexpected, related to the research and puts research subjects or others at greater risk of harm should be reported to the IRB. The IRB also requests that you report all research subject deaths, even if the death is unrelated to the research.

If the PI determines the event has substantial adverse effect on the safety or welfare of the study subject(s) or have substantial adverse effect on the value of the data collected, the report must be submitted within 7 days of the site becoming aware of the event.

Please Note: All reports will be reviewed by the full convened IRB.

Potential Unanticipated Problem or Serious or Continuing Non-Compliance Form

PLEASE PROVIDE ALL REQUESTED INFORMATION

Reports should be submitted to the IRB within 7 days of event notification/discovery of the event.

1. Study/Site Information

Today’s Date:
IRB ID Number: (IM#/CW#/CIRB#)
Complete Study Title:
Site:
Sponsor:
PI Name:
Contact Name:
Treating Physician/Investigator Name:
CRA/Study Coordinator Name:
Study Contact Phone #:
Study Contact E-Mail:
Research involved the use of a: / Drug Device Procedure Other

2. Subject Information

Subject ID Number:
Is the study still open to enrollment? / Yes No N/A – study does not enroll subjects
Is the subject still on active treatment? / Yes No N/A – study does not enroll subjects

3. Event Information (report all events that are unexpected, related to the research and puts the subject or others at increased risk of harm)

Date of event:
Date site became aware of event:
Date submitted to sponsor:
If the event was discovered longer than 7 days ago, please explain why this report is being submitted late:
Initial or follow-up report: / Initial Report Follow-Up Report #

Event Description and Reason (check all that apply)

Hospitalization (initial or prolonged) / Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Life Threatening / Death
Disability or Permanent Damage / Subject Withdrawal from Trial
Congenital Anomaly/Birth Defect / Other:
Briefly describe the adverse event.

Resolution and Corrective Action/Management Plan

Please describe the corrective measures that have been put into place to prevent similar non-compliance issues from occurring in the future. You may attach pages if additional space is needed.

4. Investigator Opinion – Please include a detailed explanation for each answer given below.

A. / Does the incident place the subject(s) or others at greater risk of harm (economic or social) than previously known or recognized?
Please explain: / Yes No
B. / Does the incident fit the definition of potential serious noncompliance?
Please explain: / Yes No
C. / Does the incident fit the definition of continuing non-compliance?
Please explain: / Yes No
D. / Does this incident have substantial effect on the safety or welfare of the study subject?
Please explain: / Yes No
E. / Were changes or actions taken to eliminate apparent immediate harm to subjects, prior to obtaining IRB approval?
Please explain: / Yes No
F. / Does this incident have substantial adverse effect on the value of the data collected?
Please explain: / Yes No
G. / Should any immediate action be taken to protect the safety and welfare of subjects already enrolled on this protocol or other persons associated with the research?
Please explain: / Yes No
H. / Do you recommend notifying locally enrolled participants about this incident?
Please explain: / Yes No

K. Based on your review of the information, what is the relationship of the event to the research?

Related – clearly related / Probably Not – unlikely to be related
Probably – likely related / Possibly Not – may not be related
Possibly – may be related / Undetermined – PI has not yet determined
Unknown – relation not known

Person Completing Form Date

Primary Investigator Signature Date

Potential Unanticipated Problem or Serious or Continuing Non-Compliance Form

PLEASE PROVIDE ALL REQUESTED INFORMATION

This section to be completed by IRB Chair, Vice-Chair or designated reviewer.

IRB Review:

Date Reviewed by Full Board: / Date:
A. / Is the incident unexpected in terms of nature, severity or frequency? / Yes No Possibly
Explanation:
B. / Is the incident related or possibly related to participation in the research study? / Yes No Possibly
Explanation:
C. / Does the incident place the subject(s) or others at greater risk of harm (economic or social) than previously known or recognized? / Yes No Possibly
Explanation:
D. / Does the incident fit the definition of potential serious noncompliance? / Yes No Possibly
Explanation:
E. / Does the incident fit the definition of continuing non-compliance? / Yes No Possibly
Explanation:
F. / Does this incident have substantial effect on the safety or welfare of the study subject? / Yes No Possibly
Explanation:
G. / Were changes or actions taken to eliminate apparent immediate hazard to subjects, prior to obtaining IRB approval? If not, should they have been? / Yes No N/A
Explanation:
H. / Does this incident have substantial adverse effect on the value of the data collected? / Yes No Possibly
Explanation:
I. / Should any immediate action be taken to protect the safety and welfare of subjects already enrolled on this protocol or other persons associated with the research? / Yes No N/A
Explanation:
J. / Should the study be temporarily suspended or terminated? / Suspended Yes No Terminated Yes No
Explanation:
K. / Is the proposed management plan sufficient to manage this event?
(i.e. audit study file every 6 months/special education to study team/etc.) / Yes No N/A
Explanation:
L. / Is further investigation required by HRPP Coordinator? / Yes No
Explanation:
IRB Event Determination
A. / This event does not meet the criteria for serious non-compliance or continuing non-compliance. / Acknowledged by IRB Chair/Vice Chair (initials): ______
B. / This event potentially meets the criteria for serious non-compliance or continuing non-compliance. / Acknowledged by IRB Chair/Vice Chair (initials): ______
Explanation:
C. / Event is reportable to FDA and OHRP? / Yes No
Explanation:
D. / Date reported to FDA, copy: PI/Study Team:
E. / Date reported to OHRP, copy: PI/Study Team:
F. / Date event added to IRB database:

I do not have a personal, scientific or financial interest in this study.

IRB Chair or Vice Chair Date

HRPP Coordinator Date

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