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