Tier Assessment Employee name: Site & Study Management: Managing Risk Date: Candidate testing level: F S A Mode: QA Review Competency Fundamental Skilled Advanced Ensure that is conducted in Has some Independently Ensure that multiple studies are compliance with institutional responsibility for responsible for conducted in compliance with requirements and other policies. compliance with compliance with institutional requirements and other Oversee maintenance of institutional institutional policies. Demonstrates application Delegation of Authority Logs requirements for at requirements and of knowledge of risk management and training of KP on study least one study. other policies for at outside of individual job or assigned specific duties. least one study. studies. Protocol selected for review (reviewer’s choice): Pro: _________________ Reviewer, randomly select 3 participant files that are the responsibility of the candidate, handled within the past 3 months. ______________ ______________ ___________ REVIEWER CHECKLIST Has the research protocol been registered on ? Yes No N/A Is the approved RDSP current? Yes No N/A Are Duke University Financial Services Guidance Documents related to participant payment and/or expense reimbursement being used? Yes No N/A Is an IRB Personal Data Disclosure Form completed for each subject who is entitled to receive compensation for participation in an IRB-approved research study conducted within the School of Medicine, School of Nursing, or DUHS? Yes No N/A If team is collecting social security numbers, is the protocol registered in eGRC? Yes No N/A
Tier Assessment Employee name: Site & Study Management: Managing Risk Date: Candidate testing level: F S A Mode: QA Review Competency Fundamental Skilled Advanced Ensure that is conducted in compliance with institutional requirements and other policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties. Has some responsibility for compliance with institutional requirements for at least one study. Independently responsible for compliance with institutional requirements and other policies for at least one study. Ensure that multiple studies are conducted in compliance with institutional requirements and other policies. Demonstrates application of knowledge of risk management outside of individual job or assigned studies. Protocol selected for review (reviewer’s choice): Pro: _________________ Reviewer, randomly select 3 participant files that are the responsibility of the candidate, handled within the past 3 months. ______________ ______________ ___________ REVIEWER CHECKLIST Has the research protocol been registered on ? Yes No N/A Is the approved RDSP current? Yes No N/A Are Duke University Financial Services Guidance Documents related to participant payment and/or expense reimbursement being used? Yes No N/A Is an IRB Personal Data Disclosure Form completed for each subject who is entitled to receive compensation for participation in an IRB-approved research study conducted within the School of Medicine, School of Nursing, or DUHS? Yes No N/A If team is collecting social security numbers, is the protocol registered in eGRC? Yes No N/A
sm_-_managing_risk-_assessment_-_qa_0.docx