Tier Assessment Employee name: Click or tap here to enter text.
Site & Study Management: Managing Risk Date: Click or tap here to enter text.

Candidate testing level: F ☐ S ☐ A ☐

Mode: QA Review

Competency / Fundamental / Skilled / Advanced
Ensure that study 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

1.  Has the research protocol been registered on www.clinicaltrials.gov?

☐ Yes

☐ No

☐ N/A

2.  Is the approved RDSP current?

☐ Yes

☐ No

☐ N/A

3.  Are Duke University Financial Services Guidance Documents related to participant payment and/or expense reimbursement being used?

☐ Yes

☐ No

☐ N/A

4.  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

5.  If team is collecting social security numbers, is the protocol registered in eGRC?

☐ Yes

☐ No

☐ N/A

6.  Are all Key personnel in the electronic IRB submission system up-to-date?

☐ Yes

☐ No

☐ N/A

7.  Is the Delegation of Authority/Signature log complete and up to date?

☐ Yes

☐ No

☐ N/A

8.  Is all required documentation of human subjects research training and certifications accurate and complete?

☐ Yes

☐ No

☐ N/A

Other comments relevant to candidate’s competency to manage risk: Click or tap here to enter text.

Evaluation Level

This documentation demonstrates:

☐ Fundamental Competency

☐ Skilled Competency

☐ Advanced Competency

Reviewer/Manager comments about candidate’s competency level:
Click or tap here to enter text.

Reviewer Name (Print):

Reviewer Title (Print):

Reviewer Signature: Date:

Assessment – SM: Managing Risk - Page 3