Overview
The mission of the Clinical Research Unit (CRU) for the Department of Psychiatry and Behavioral Sciences at Duke University is to support, oversee, and serve as the organizational home for all clinical research conducted within the department.
The CRU is responsible for the scientific integrity, quality, academic productivity, regulatory compliance, and financial solvency of all clinical research conducted in the department.
Clinical Research Unit Charter [1]
Guidelines
Forms
Policies
Useful Links
Guidelines
IRB Submission - coming soon
Research Data Security Plan (RDSP) Overview - coming soon
RDSP Guidelines for Paper Document Storage - coming soon
Guildelines for Clinical Trials.Gov [2]
Forms
The mission of the Clinical Research Unit (CRU) for the Department of Psychiatry and Behavioral Sciences at Duke University is to support, oversee, and serve as the organizational home for all clinical research conducted within the department.
Enrollment Log Template [3]
Suggested Regulatory Binder Documents [4]
Sample Signature and Delegation of Authority Log [5]
Tier and Fee Schedule [6]
Internal Cost Summary Templates: Grant or Department-Funded Research [7]; Industry-Sponsored Research [8]
Policies
Policy for Access to e-Browser [9]
Policy on Clinical Research Unit (CRU) Scope of Oversight [10]
Policy on Collaborative Institutional Training Initiative (CITI) [11]
Policy on Collecting or Storing Social Security Numbers [12]
Policy on Obtaining and Sending Informed Consent to Duke Health Information Management (HIM [13])
Policy on Quality Assurance Monitoring [14]
Useful Links
Duke Institutional Review Board [15]
Duke Office of Clinical Research [16]
Occupational & Environmental Safety Office [17]
