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Prepare for research audits and monitoring
Need assistance with research audits or monitoring?
Research audits and monitoring are in place to ensure that participants and animals in studies and trials are protected, and that the quality and integrity of the research is maintained. It is important for research teams to know how to be prepared for audits and monitoring visits, who to contact, and how best to collaborate with monitors and auditors. Being "at the ready" and knowing where to turn for assistance is particularly critical for this task.
The tables below can be used to understand how to prepare for different types of monitoring or audits.
Internal Audits
| Type of Audit | Information | Who to Contact |
|---|---|---|
| Laboratory safety evaluations |
In order to support compliance with laboratory safety policies and procedures in the Duke University research laboratories, the Occupational and Environmental Safety Office’s (OESO) Laboratory Safety Division requires routine safety evaluations of each Principal Investigator’s laboratory. The laboratory safety evaluation, conducted by a Safety Specialist, consists of a review regarding safety issues related to federal, state, or local regulations or guidelines. Access the Lab Safety Evaluation Website for information on these regulations and how to prepare for a laboratory safety evaluation. |
Email labsafety@dm.duke.edu or call 919-684-8822 |
| Office of Animal Welfare Assurance audits | The Duke Animal Care and Use Program monitors approved animal activities on an ongoing basis. Refer to this guidance document about post-approval monitoring. To ensure a successful audit of animal activity and space, ensure all animal procedures are being performed in accordance with approved IACUC protocol, Animal Program Policies, and SOPs. |
Contact the Office of Animal Welfare Assurance (OAWA) |
|
Office of Audit Risk and Compliance audits |
The Office of Audit Risk and Compliance (OARC) consults with key stakeholders across Duke to develop an annual risk-based audit plan, and adjusts the audit plan based on institutional priority shifts, timing contingencies, and advisory project requests. OARC audits provide assurance that business processes and internal controls are adequately designed and operating effectively, and identifies opportunities to make Duke more efficient and effective in achieving its objectives. Access the OARC website for more information. |
Email oarc@dm.duke.edu or call 919-613-7630 Duke Health Integrity Line and Duke Speak Up Program: (800) 826-8109 |
| Plant accounting audits |
Plant Accounting conducts equipment audits at least once every two years of all University departments, including all research departments. Access the Plant Accounting website for general principals and guidance around capital equipment and fixed assets. |
For questions about Plant Accounting equipment inventories, contact Dan Parler or Brad Walker |
| Other equipment audits | Less frequent equipment audits include KPMG A-133 audits, and DHHS space utilization audits. If an equipment audit is requested, the research team should contact Duke Financial Services for guidance through the process. | Contact PlantAccounting@duke.edu to determine the best contact to help with other equipment audits |
External Audits
|
Type of Audit |
Information |
Who to Contact |
|---|---|---|
|
American Association for Accreditation of Laboratory Animal Care audits |
The Duke Animal Care and Use Program maintains AAALAC International accreditation. This is a voluntary third-party accreditation process that helps ensure Duke maintains a strong bridge between progress and animal well-being. It also demonstrates excellence for grants, awards, and collaborations. |
For more information related to AAALAC International please contact: |
|
Database of Genotypes and Phenotypes (dbGaP) audits |
It is the lead researcher’s responsibility to make sure all team members abide by the dbGaP Approved User Code of Conduct. A copy of the agreement signed by all authorized team members should be kept on file for audit purposes. Those utilizing dbGaP data must renew their access request every year. To initiate a renewal or to submit a new dbGaP request submit via this REDCap form. Learn more about Duke’s process for dbGaP. |
Contact the Research Navigators: |
|
Food and Drug Administration audits |
The Food and Drug Administration (FDA) may audit projects as part of a routine inspection or for-cause inspection. Adherence to this guidance of what to document and who to involve should be ensured if investigators are notified by the FDA of an audit or an auditor arrives unannounced. |
If the FDA announces an audit the following personnel from the Office of Audit, Risk, and Compliance should be notified immediately: Vanessa Peoples
If a project involves use of an investigational product (drug, biologic, medical device), then the Office of Regulatory Affairs and Quality should also be notified:
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Other animal-related audits |
Other outside entities may audit the Duke Animal Care and Use Program based on specific grant or funding requirements. This includes but is not limited to inspections by the Department of Defense, Veterans Affairs, and/or the Office of Laboratory Animal Welfare at the NIH. The timing of these visits can vary.
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Contact the Office of Animal Welfare Assurance (OAWA) via email IACUC@duke.edu or call 919-668-6720 |
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United States Department of Agriculture audits |
The Duke Animal Care and Use Program is obligated to follow the requirements of the Animal Welfare Act and Animal Welfare Regulations. In order to ensure compliance, the United States Department of Agriculture (USDA) performs annual, unannounced, inspection of our Animal Care and Use Program. |
For more information related to USDA Inspections please contact: |
Internal Monitoring
|
Type of Monitoring |
Information |
Who to Contact |
|---|---|---|
|
Clinical Quality Management Program (CQMP) |
The Clinical Quality Management Plan Policy outlines the type of studies and frequency of review for studies that will require monitoring under the CQMP. Trained QM reviewers are required to complete and enter regulatory and participant chart reviews into the CQM Database within 30 days of the end of the review period according to the respective study complexity level. QM reviewers are encouraged to use the tools available through DOSI when developing Clinical Quality Management Plans and conducting both the regulatory and participant chart reviews. |
Email CQMP@duke.edu |
|
Research Quality Management Program (RQMP) |
Each School of Medicine department, center, and institute have a designated Research Quality Team (RQT) to ensure implementation of best practices with regards to quality, integrity and accountability in research. The RQT will work with the Duke Office of Scientific Integrity (DOSI) to monitor their unit for research quality in: Research Administration, Science Best Practices, Data Management, and Accountability. |
Email rqmp@duke.edu or utilize the DOSI weekly RQMP Office Hours for additional support. |
External Monitoring
|
Type of Monitoring |
Information |
Who to Contact |
|---|---|---|
|
On-site sponsor monitoring |
To prepare for an on-site sponsor monitoring visit:
|
Email DOCR.Help@dm.duke.edu for questions or assistance with on-site sponsor monitoring |
|
Remote sponsor monitoring |
Remote monitoring is only allowed for authorized studies that have an agreement in place between the sponsor and the Office of Research Contracts (ORC). Remote monitoring must be included in the IRB application and the remote monitoring language included in the consent form. Monitor access is requested the same way as on-site monitoring, using the Research Auditor/Monitor Access to Maestro Care Request Form. |
Email DOCR.Help@dm.duke.edu for questions or assistance with remote sponsor monitoring |