Who can be a PI?
This is covered in a SOM policy. Generally any faculty member in the School of Medicine and senior administrative staff are granted PI status. This status is available to faculty on tenure tracks I through III and to other regular rank faculty on the Research Professor, Clinical Professor, and Professor of the Practice of tracks.
What are the training requirements for PIs?
Initial PI training includes completion of the Duke Medicine CITI modules, Responsible Conduct of Research training, and Duke Data Integrity and Security training.
Is there other training recommended?
Other training is based on the roles carried out in the conduct of the study. This may include Obtaining Informed Consent, Investigator Responsibilities and Study Documentation. These classes are developed by DOCR, and registration is available on the Learning Management System (LMS) website.
I'm interested in an industry-sponsored trial. What are the next steps?
The Medical CRU can help coordinate all of the next steps. Please visit the industry-sponsored research page to learn more.
What is the Clinical Quality Management Plan (CQMP)?
One of the most important changes affecting clinical research at Duke University is the requirement of a Clinical Quality Management Program (CQMP) for most research studies. Learn more.
What are the types of agreements handled by ORC?
a. Types of contracts-managed by ORC
i.Confidential Disclosure Agreement (CDA): also referred to as a Non-Disclosure Agreement (“NDA”), is an agreement between two or more parties that outlines the terms under which the parties will exchange information for a specified purpose. Duke researchers should generally not sign CDAs in their own name and are not authorized to sign CDAs on behalf of Duke – all CDAs should be submitted to ORC to obtain the proper review and signature.
ii. Data Transfer Agreement (DTA): The transfer and use of human subject data is a complicated issue. Duke researchers wishing to transfer or use human subject data must contact ORC to initiate a discussion on the proposed data transfer or use.
iii. Material Transfer Agreement (MTA): an agreement entered into by the parties to govern the provision or receipt of research material.
iv. Clinical Trial Agreement (CTA) or Research Agreement (RA): a contract that establishes the relationship between Duke and another party (the “External Entity”) under which Duke receives funding and/or a study drug or device to support the research project. The research may be non-clinical, preclinical, or clinical. The RA defines the terms under which the research will be conducted, such as the specific research scope of work, the budget and payment terms, and the research timeline.
b. ORA manages federal and foundation agreements
When do I need a Data Transfer Agreement or a Materials Transfer Agreement?
a. Any time a researcher would like to transfer data from Duke or use data coming from outside of Duke, a DTA should be negotiated through ORC.
b. A Materials Transfer Agreement (MTA) is necessary to define the terms for the exchange of material between Duke and another party.
Note: These agreements cover the transfer of material or data for research purposes. However, the IRB must approve any use of material or data for research. The IRB must also be notified of any research data or material being moved outside of Duke.
Why can’t I sign my own contracts?
An individual signing a contract creates an agreement between the sponsor and that individual. Duke has no requirement to honor a contract signed by an individual employee. A non-Duke signatory who signs a contract, can be held personally responsible for the terms of the contract.
What is billing risk?
Any time services are provided through Duke Medical Center, there is a potential for a bill to be generated. For example, billing risk occurs when a clinical phlebotomist draws blood from a research participant, even though the test may be sent out to a non-Duke lab.
ICA…what is it, why do I need it, who can help?
The Internal Cost Assessment (ICA) is a tool to assist in the development of an acceptable budget. It is meant to help the study team assess the actual cost of all study procedures as well as staff and faculty effort necessary to conduct the research. The FPM and the CRU staff can help in creating the required ICA.
How do we do “unfunded” research?
We recognize the importance of pilot projects that may lead to funding, or the need to do unfunded research for multiple reasons. Divisions must provide approval for all unfunded research. Despite the lack of funding, an ICA is still required, so that the division understands and agrees to cover the cost of the unfunded project. A fund-code is required as Duke policy, in the event there is a charge related to the research.
How do I know how my funds are being spent?
It is the responsibility of the PI to manage the financial health of each project. Monthly reports are supplied by the CRU financial staff. Information includes earned revenue and expenses for the current month and year-to-date. Investigators are encouraged to meet with the FPM and Lead CRC on a monthly basis to review these reports. Around the eighth or ninth of each month you will receive an email from FIBATCH email@example.com. Upon notification, go to your Duke's Box: https://box.duke.edu/, click on your Home Folder, click on your Monthly Financial Reports, open the files that were most recently added. Open those files in Excel.
What constitutes a Conflict of Interest?
A conflict of interest occurs when there is a personal or financial relationship between the PI and the sponsor or anyone else who might profit from the study. Relationships are reported to the COI committee. The committee will develop a management plan, which must be approved by the IRB. Full policy regarding COI can be found on the IRB website.
What happens to my funds and data if I leave Duke?
All research data collected at Duke must remain at Duke. Contracts can be executed for the transfer of data and/or samples if the research study is to be moved to another institution. Funds can also be transferred with an appropriate contract. Note that investigators with an adjunct Duke faculty position will not be able to serve as PI at Duke.
What is the Delegation of Authority (DOA) log?
This log may be known as the signature log. This documents the delegation of research duties by the PI to appropriately trained staff.
A template of a DOA log can be found on the DOCR website.
Who belongs on the DOA log?
Anyone having contact with human participants or their identified data or specimens is required to be on the DOA log.
How do I hire a research assistant or a coordinator?
Research coordinators are skilled professionals with specific abilities in the clinical and administrative areas. The CRU RPM will help in assessing what level of coordinator or research assistant is needed. All research positions must be approved by the RPM and the Departmental Vice Chair for Administration. Please contact the Medicine RPM for information.
What is the difference between the CRU and DOCR?
The Clinical Research Unit is the departmental structure responsible for the oversight of human subject research.
DOCR is the School of Medicine structure that provides oversight to the CRUs.
What does the CRU do for me?
The Medicine CRU strives to assist investigators in all aspects of conducting human research. We develop and monitor training, conduct quality reviews for early correction of errors, are well versed in GCP guidelines and federal regulations so that we can help to ensure the quality of research. We are available to answer questions, can help in providing adequate staffing, and participate in all aspects of financial management. We strive to relieve the PI from the administrative burden of conducting human research.
What are the School of Medicine shared resources?
Duke University and School of Medicine shared resources offer state-of-the-art research support services and facilities to Duke investigators. Over 70 shared resources provide expertise in a broad range of research needs. Housed and administered by the School’s departments, institutes, and centers, these shared resources are staffed by experts in their fields and are available to the Duke research community.
Office of Research Resources
Jennifer Foreman, Research Resources Manager
Duke University and Duke University School of Medicine offer state-of-the-art shared research facilities that are available for use by all Duke investigators. Core facilities are physically housed and administered by Duke research institutes and centers, including the Duke Cancer Institute and the Duke Human Vaccine Institute. Cores with an asterisk (*) are live on CoreResearch@Duke.
The Medicine CRU team can help you identify additional resources specific to your research.