Reviewing, requiring modifications necessary) and approving proposed CAP associated with minor non-compliance and where the CAP represents no more than a minor change in research Ensuring the CAP is implemented for minor IRB non-compliance Reviewing (directly or through assignment to an IRB Administrator) RNI involving incidental incarceration of a subject, premature study suspension or termination, information that indicates a new or increased risk or safety issue (or decrease in study benefits), and any Data and Safety Monitoring Board (DSMB) or other study monitoring reports Coordinating (directly or through assignment to an IRB Administrator) IRB review of any RNI involving incidental incarceration of a subject, premature study suspension or termination, information that indicates a new or increased risk or safety issue (or decrease in study benefits), or DSMB or other study monitoring reports IRB committee is responsible for: Reviewing, requiring modifications (where necessary), and approving any proposed CAP associated with research RNI determined to be an unanticipated problem, unanticipated adverse device effect, serious non-compliance, continuing or where the proposed CAP represents more than a minor change in research Reviewing RNI involving incidental incarceration of a subject, premature study suspension or termination, information that indicates a new or increased risk or safety issue (or decrease in study benefits), and any Data and Safety Monitoring Board (DSMB) or other study monitoring reports HSD Management is responsible for: Reviewing, requiring modifications (where necessary), and approving any proposed CAP associated with IRB-related RNI determined to be serious and/or continuing and ensuring the CAP is implemented Institutional Official is responsible for: Reviewing, requiring modifications (where necessary), and approving any proposed CAP associated with IRB-related RNI determined to be serious and/or continuing PROCEDURE: HSD Assessment and Determination Initial intake of RNI. The completed is received by email at: . The email account is checked daily for new submissions. Any submitted to HSD in physical paper format is date stamped and routed to the HSD Compliance Administrators for intake (See and the for details on the intake process).
Reviewing, requiring modifications necessary) and approving proposed CAP associated with minor non-compliance and where the CAP represents no more than a minor change in research Ensuring the CAP is implemented for minor IRB non-compliance Reviewing (directly or through assignment to an IRB Administrator) RNI involving incidental incarceration of a subject, premature study suspension or termination, information that indicates a new or increased risk or safety issue (or decrease in study benefits), and any Data and Safety Monitoring Board (DSMB) or other study monitoring reports Coordinating (directly or through assignment to an IRB Administrator) IRB review of any RNI involving incidental incarceration of a subject, premature study suspension or termination, information that indicates a new or increased risk or safety issue (or decrease in study benefits), or DSMB or other study monitoring reports IRB committee is responsible for: Reviewing, requiring modifications (where necessary), and approving any proposed CAP associated with research RNI determined to be an unanticipated problem, unanticipated adverse device effect, serious non-compliance, continuing or where the proposed CAP represents more than a minor change in research Reviewing RNI involving incidental incarceration of a subject, premature study suspension or termination, information that indicates a new or increased risk or safety issue (or decrease in study benefits), and any Data and Safety Monitoring Board (DSMB) or other study monitoring reports HSD Management is responsible for: Reviewing, requiring modifications (where necessary), and approving any proposed CAP associated with IRB-related RNI determined to be serious and/or continuing and ensuring the CAP is implemented Institutional Official is responsible for: Reviewing, requiring modifications (where necessary), and approving any proposed CAP associated with IRB-related RNI determined to be serious and/or continuing PROCEDURE: HSD Assessment and Determination Initial intake of RNI. The completed is received by email at: . The email account is checked daily for new submissions. Any submitted to HSD in physical paper format is date stamped and routed to the HSD Compliance Administrators for intake (See and the for details on the intake process).
PAPER-SOP-HSD-Management-of-Reports-of-New-Information.docx