rights or welfare of participants, compromises the confidentiality of participants, or compromises the scientific integrity or validity of the research. In the "Describe the problem" section below, please: Explain if the event has substantial adverse effect on the safety or welfare of subjects, if the event is unexpected in terms of nature, severity or frequency, if the event, experience or outcome places the subjects at greater risk of economic or social harm than previously known or recognized, if the event has a substantial adverse effect on the value of the data. Potentially Continuing Noncompliance A series of actions of noncompliance with the protocol, federal regulations, or the requirements of the Guthrie Clinic IRB, that if unaddressed, could jeopardize the safety, rights or welfare of research participants or compromise the integrity or validity of the research. In the "Describe the problem" section below, please answer: What are the number of events? Has the same noncompliant event been repeated, or have many different noncompliant events occurred? Have corrective actions already been implemented to prevent the noncompliance from recurring in the future? Protocol deviation that harmed a subject or placed subject at risk of harm In the "Describe the problem" section below, please explain: Any harm the subject experienced OR how the subject was placed at risk of harm. In the "What actions need to be taken" section below, please explain: The corrective action taken for this event AND your plans to avoid future occurrences. Protocol deviation made without prior IRB approval to eliminate an apparent immediate harm to a subject In the "Describe the problem" section please explain: Describe the subject's situation and why immediate action was required. State if sponsor was notified (attach any correspondence) In the "What actions need to be taken" section below, please explain: Your plans to avoid future occurrences, if applicable. Unanticipated problems involving risks to human subjects or others (UPIRSOs) Unanticipated problems include adverse events other incidents, experiences, and and outcomes that are not adverse events that meet all of the following criteria: 1) (in terms of nature, severity, or frequency) given (a) the research procedures unexpected that are described in the protocol and related documents, such as the investigator’s brochure and the informed consent document; and (b) the characteristics of the subject population being studied;
rights or welfare of participants, compromises the confidentiality of participants, or compromises the scientific integrity or validity of the research. In the "Describe the problem" section below, please: Explain if the event has substantial adverse effect on the safety or welfare of subjects, if the event is unexpected in terms of nature, severity or frequency, if the event, experience or outcome places the subjects at greater risk of economic or social harm than previously known or recognized, if the event has a substantial adverse effect on the value of the data. Potentially Continuing Noncompliance A series of actions of noncompliance with the protocol, federal regulations, or the requirements of the Guthrie Clinic IRB, that if unaddressed, could jeopardize the safety, rights or welfare of research participants or compromise the integrity or validity of the research. In the "Describe the problem" section below, please answer: What are the number of events? Has the same noncompliant event been repeated, or have many different noncompliant events occurred? Have corrective actions already been implemented to prevent the noncompliance from recurring in the future? Protocol deviation that harmed a subject or placed subject at risk of harm In the "Describe the problem" section below, please explain: Any harm the subject experienced OR how the subject was placed at risk of harm. In the "What actions need to be taken" section below, please explain: The corrective action taken for this event AND your plans to avoid future occurrences. Protocol deviation made without prior IRB approval to eliminate an apparent immediate harm to a subject In the "Describe the problem" section please explain: Describe the subject's situation and why immediate action was required. State if sponsor was notified (attach any correspondence) In the "What actions need to be taken" section below, please explain: Your plans to avoid future occurrences, if applicable. Unanticipated problems involving risks to human subjects or others (UPIRSOs) Unanticipated problems include adverse events and other incidents, experiences, and outcomes that are not adverse events that meet all of the following criteria: 1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol and related documents, such as the investigator’s brochure and the informed consent document; and (b) the characteristics of the subject population being studied;
109%20Promptly%20Reportable%20Events%20form%202018%20Jan.docx