RESEARCH COMPLIANCE ASSESSMENT FORM
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Organization | |
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Person Completing Assessment: | |
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Title of Person Completing Assessment: | |
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Date Assessment Completed: | |
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Notes: |
Area 1: Written policies and procedures
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# |
Description |
Yes |
No |
Evidence of Compliance or action required Include specific references to documents that support and “Yes” response |
Additional Notes |
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1.1 |
Do you have a written policy(s) and procedure(s) that describe compliance expectations for research? |
☐ |
☐ | ||
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1.2 |
Have you implemented the operation of research compliance program? |
☐ |
☐ | ||
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1.3 |
Do you have a written policy and procedure that provides guidance to employees on dealing with potential research compliance issues? |
☐ |
☐ | ||
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1.4 |
Do you have a written policy and procedure that provides guidance on how to communicate research compliance issues to appropriate compliance personnel? |
☐ |
☐ | ||
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1.5 |
Do you have a written policy and procedure that provides guidance on how potential research compliance problems are investigated and resolved? |
☐ |
☐ |
Area 2: Designate an employee vested with responsibility
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# |
Description |
Yes |
No |
Evidence of Compliance or action required Include specific references to documents that support and “Yes” response |
Additional Notes |
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2.1 |
Has a designated employee been vested with responsibility for the day-to-day operation of the research compliance program? |
☐ |
☐ | ||
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2.2 |
Are the designated employee’s duties clearly defined? |
☐ |
☐ | ||
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2.3 |
If the designated employee’s research compliance duties are combined with other duties, are the research compliance responsibilities satisfactorily carried out? |
☐ |
☐ | ||
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2.4 |
Is there a “subject matter expert” outside of the designated employee with oversight of research compliance? |
☐ |
☐ | ||
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2.5 |
Does the “subject matter expert” have qualifications satisfactory to be an “expert”? |
☐ |
☐ | ||
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2.6 |
Does the designated employee periodically report directly to the governing body on the activities of the research compliance program? |
☐ |
☐ |