GUTHRIE Institutional Review Board

Return this form to:
Elaine Wall, IRB Coordinator, Guthrie Foundation

570-887-4885;

4 Feb 2013

Page 1 of 3

Potentially Serious or Continuing Noncompliance Report Form

Study Information
IRB #
Submission Date
Protocol #
Protocol Title
Sponsor
Principal Investigator
Person completing form
Date of event
Date site became aware
Date sponsor notified

Noncompliance refers to any actions that deviate from the approved protocol, deviates from the IRB requirements, or fail to adhere to federal, state or local regulations governing human subjects research.

Individual events of noncompliance are not reportable to the Guthrie IRB unless they are:

·  potentially serious noncompliance OR

·  potentially continuing noncompliance

1.)  Serious noncompliance means an action or activity that adversely affects the safety, rights or welfare of participants, compromises the confidentiality of participants, or compromises the scientific integrity or validity of the research.

Does the event meet the above definition of serious noncompliance? / Yes No
Has this event adversely affected the safety, rights or welfare or compromised the confidentiality of participants? / Yes No
Has this event compromised the scientific integrity or validity of the research? / Yes No

Potentially Serious Noncompliance Description and Reason:

If yes, to any of the questions above, provide a description of the event and include a description of actions that were taken to resolve the event. You may attach pages if additional space is needed.

2.)  Continuing noncompliance means a series of actions or activities that are at variance with the Guthrie Health Program for Protection of Human Research Participants and the relevant federal and state laws and regulations on which they are based, or that compromise the integrity or validity of the research. In determining whether noncompliance is continuing, the frequency of noncompliance is assessed mainly by the number of incidents, and would also take account whether the same noncompliant action was repeated or many different noncompliant events occurred.

Does the event meet the above definition of continuing noncompliance? / Yes No
Has this event occurred more than once? / Yes No
Is this event likely to occur again? / Yes No

Potentially Continuing Noncompliance Description and Reason:

If yes, to any of the questions above, provide a description of the event and include a description of actions

that were taken to resolve the event. You may attach pages if additional space is needed.

3.) Does the event affect the study participant’s continued participation in the study? Yes No

Provide subject information and Explain

Subject Initials
Subject Study #
Is the subject on active treatment? / Yes No N/A

4.)  Resolution and Corrective Action:

Describe the corrective measures that have been put into place to prevent similar noncompliance issues from occurring in the future. You may attach pages if additional space is needed.

If the noncompliance suggests that the research places subjects or others at a greater risk of harm then also report this event as an unanticipated problem involving risks to subjects or others (UPIRSOs) per policy 322-052.

Investigator Signature

______

Signature Date


IRB Review:

Further investigation required. Requested information
______
______
The above event does not meet the criteria of serious noncompliance or continuing noncompliance. / Acknowledged:
No action required by investigator.
The above event potentially meets the criteria of serious or continuing noncompliance. / Referred for a Review at a Convened Meeting

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

______

IRB Chair/ Designated Reviewer Date

Potentially Serious or Continuing Noncompliance

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