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The information below has links to the relevant NIH polices that provide information regarding investigators’ responsibilities for reporting research related events to the IRB in PROTECT. Links to additional resource materials are also provided. Please submit any questions you have about reporting research related events to the IRB to the OHSRP Compliance and Training mailbox at OHSRPCompliance@od.nih.gov.

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Alt	Reporting Research Related Events to the IRB
Filename	templates-and-forms-card.svg
Title	Reporting Research Related Events to the IRB
Page	display/ohsrp/Reporting+Research+Related+Events+to+the+IRB

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Alt	Noncompliance
Filename	templates-and-forms-card.svg
Title	Noncompliance
Page	display/ohsrp/Noncompliance

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Alt	Unanticipated Problems
Filename	policy-archive.svg
Title	Unanticipated Problems
Page	display/ohsrp/Unanticipated+Problems

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Alt	Reporting Events on FDA Regulated Studies
Filename	templates-and-forms-card.svg
Title	Reporting Events on FDA Regulated Studies
Page	display/ohsrp/Reporting+Events+on+FDA+Regulated+Studies

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Alt	Reporting Participant Concerns
Filename	policy-archive.svg
Title	Reporting Participant Concerns
Page	display/ohsrp/Reporting+Participant+Concerns

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Report Table

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Old Version 42

New Version 43

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