Clinical Research Resource - Medicine Shared Resources - Research - Department of Medicine (2024)

Confidential Disclosure Agreement process:Before sharing proprietary or confidential information with an investor, industry representative or other entity, we recommend innovators have anon-disclosure agreement (NDA).This document, also known asa confidential disclosure agreement (CDA),specifies how recipients will protect and use the confidential information. At the University of Rochester, CDAs are processed through theOffice of Research and Project Administration (ORPA).Remember to reach out to yourResearch Administrator in Medicinewho can assist with this process.

Office of Clinical Research Feasibility Assessment Process:Available to clinical research teams’ enterprise wide. OCR can help youassess the feasibility of proposed clinical studiesand develop meaningful metrics to help guide how you manage your clinical studies.We strongly encourageour investigators and study team to utilize the feasibility services to helpidentify potential risks and challenges early on before investing additional time and resources.

Once you have decided to move forward with a study, contact your assignedDOM Research Administratorto inform them. Additionally, each division has an assignedORPA Research Administratorthat they will work with.

Your Research Administrator and/or Clinical Research Manager will work with ORPA within theIntegrated Online Research Administration (IORA), the University’s comprehensive suite of web based software solutions capable of managing various research functions, from proposal development, review, routing and approval through award administration and closeout.We encourage our investigators to allow their respective division research admin to liaison with ORPA.

Submitting an NIH Funded Clinical Trial?The Department of Medicine is committed to the submission of high quality grant applications and providing support to both research administrative staff and investigators in compiling appropriate documents, to help streamline the process and increase quality and success of applications. OurNIH Pre-Award Toolkitis currently tailored to NIH Grant Submissions, focusing on R Series, K Series and F Series applications.

NIH Definition – Clinical Trial
Understand what is considered a NIH Clinical Trial and if your Human Subjects Research study meets the NIH Definition of a Clinical Trial

NIH Funded Clinical Trials
All NIH-funded clinical trials are expected to register and submit results information toClinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals submitted on or after January 18, 2017. This website provides resources for understanding requirements for registering and reporting results for NIH Funded Clinical Trials to comply with this NIH policy and the federal regulations in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801)as implemented by 42 CFR Part 11 (Final Rule).

NIH Study Requirements – Which Policies Apply to My Research?
NIH has a variety of sharing policies in place for research that it funds. This tool will assist in helping you determine which of the following NIH policies apply to a particular project

Submitting an Industry Sponsored or Investigator Initiated Clinical Trial?Visit the Office of Clinical Research to access the URMC Clinical Research Study Start-Up Manual. The manual is to review best practices concerning Study Start-Up within the University of Rochester (UR) and is to be used as an overall guideline for individuals within Study Teams to use as applicable.

Do you need additional divisional support? TheOffice of Clinical Research (OCR) helps teams manage clinical research financesfrom start to finish.Medicine Investigators should first consult with theirResearch division administratorsto determine if additional support is needed, before contacting OCR finance directly.

The OCR maintains aset of resources related to key aspects of clinical trialsthat departments involved in clinical trials can utilize. URMC research coordinators, administrators, and faculty can access and download tip sheets, memos, directions, and other important documentation to help them with various stages and aspects of clinical trials.

Clinical Research Center (CRC)
TheClinical Research Centerfacilitates safe and controlled inpatient and outpatient studies by providing infrastructure and support to clinical research teams.

Office of Regulatory Support
The Office of Regulatory Supportoffers services to help investigators understand and comply with FDA-regulated processes in research involving experimental drugs and devices and in preclinical laboratory studies.

Office of Human Subject Protection (OHSP) Resources
For research involving human subjects, the OHSP oversees the following:

• Research Subjects Review Board (RSRB)
• Research Education and Training
• Research Quality Improvement

Getting Started & Navigation Resources – All new faculty/fellows/residents are strongly encouraged to start with theGetting Started with Your Research Flowchart; it depicts the process for getting started and includes links to several other key resources. Additional key/basic resources would include:

• OHSP FAQ: When do I need to get IRB approval?
• OHSP FAQ: What do I need to include in my IRB submission?(includes links toprotocolandconsenttemplates)
• OHSP Explains… The IRB Review Process
• Click IRB Resources– The Integrated Online Research Administration (IORA) system is a suite of research-related software solutions used by the University of Rochester. Within the IORA system, the Institutional Review Board (IRB) module, referred to as Click IRB, facilitates the review and approval of human subject research. The resources on the site will assist study staff and reviewers in navigating the Click IRB system and performing activities specific to their role. Researchers can also use the hyperlinks in theStudy Staff User Guideto jump to the information you may need. This contains useful information that will help investigators navigate the system (and avoid common problems, like uploading documents incorrectly or misinterpreting questions).
• Who is your IRB Coordinator (rochester.edu)?If you still have IRB questions, this will take you to the point of contact for general IRB questions and who is assigned to each department/division.

FWA information: The documentation of an institution's commitment to comply with Federal regulations and maintain policies and procedures for the protection of human participants. On the main page of the OHSP website under “About” you will find the University of Rochester’s FWA (Federal Wide Assurances). These numbers are required when filling out a Central IRB application. The U of R FWA is:FWA00009386

OnCore

URMC’s clinical trial management system,OnCoreis a clinical trial management system that offers a central place for all researchers to manage their protocols, track research participant visits, and manage clinical trial finances, both pre- and post-award.

Recruiting Participants
Need help with Recruitment?There are many ways to advertise your clinical research studies to recruit participants, including MyChart, flyers, TV, radio, newspaper, and social media. The UR CTSI can help University of Rochester researchers improve recruitment and retention plans for their health research studies.

Participant Payments
Learn more about how to pay subjects after each clinical study visit. Participant Payments is a safe, secure automated system that helps immediately pay participants after each clinical study visit. Integrated with OnCore, Participant Payments eliminates manual and inefficient processes, so research teams can spend less time on administrative tasks and focus on patient care.

REDCap
REDCap(Research Electronic Data Capture)is a free, secure, HIPAA-compliant, web-based application used for electronic capture and management of research and clinical study data. The REDCap system, developed by Vanderbilt University, provides an intuitive user interface to enter, audit, monitor, and export data. It also helps users to create databases and web-based surveys to assist with recruitment efforts. REDCap is available at no cost to all University of Rochester members. Development consultations are available to design databases, data entry forms, or surveys.

TriNetX
TriNetXis a global network of healthcare organizations and life sciences companies driving real-world research to accelerate the development of new therapies. Through its self-service, HIPAA, GDPR, and LGPD-compliant platform of federated EHR, datasets, and consulting partnerships, TriNetX puts the power of real-world data into the hands of its worldwide community to improve protocol design, streamline trial operations, refine safety signals, and enrich real-world evidence generation.

Research Help Desk
Do you need help with a research project, but aren't sure where to start? Email theUR CTSI Research Help Desk and our team of experts will connect you with the research services, support, education, and career development opportunities you need.

ResearchEducation and Training
Refer to the– created to facilitate onboarding and training of study team members engaged in human subject research. Additional training is also available on this site.

The Orientation and Research Boot Camp courses are part of the training ‘framework’ in OHSP. They’re meant to build on the training provided via CITI and, of the courses available within the framework, are by far the most popular and good ‘starting points’. Both are available for free via Blackboard to all faculty, staff, students. Details, including enrollment instructions, are available here:https://www.rochester.edu/ohsp/education/certification/educationTrainingMaterials.html.

Are you just doing a chart review?
OHSP Explains… Retrospective Chart Reviews in the Era of the Revised Common Rule.

Institutional Biosafety Committee
TheUniversity of Rochester's Institutional Biosafety Committee (IBC)is a University-wide committee responsible for reviewing and approving recombinant or synthetic nucleic acid molecules and biohazard research projects in fulfillment of its mission. The committee is composed of faculty investigators with expertise in recombinant or synthetic nucleic acid molecules and biohazard research, staff from Environmental Health & Safety including the Biosafety Officer, and non-affiliated or community members. The IBC meets approximately every two weeks.

IF YOUR RESEARCH USES DNA, PATHOGENS, OR HUMAN TISSUES/FLUIDS, YOU WILL NEED IBC APPROVAL. Learn more about the IBC.

Data Security Form
The Data Security Form must be filled out when data is collected, transmitted, or stored electronically, and be referenced in the study protocol and included as part of the new study application in the ClickIRB system.

Clinical Research Services Offered by CHeT to Advance Human Therapeutics, Health, and Knowledge Through Exceptional People, Skillful Research, and Partnerships
CHeTis comprised of six units of expertise that collaborate to contribute to the development of new therapeutic, diagnostics, and devices. CHeT has conducted over 150 clinical research studies with 50+ sponsors, enrolling over 40,000 research participants in the US and internationally. If you or your team are looking for a proven, experienced clinical research organization to help develop, manage, and conduct clinical research studies across multiple sites, from study concept and start-up through project management, data management/analysis, monitoring, publication, and/or FDA approval support, please reach out to Melissa Kostrzebski atMelissa.kostrzebski@chet.rochester.edu. If you are interested in one of our other CHeT Units, please reach out to Norman Yung atnorman.yung@chet.rochester.edu. Watch this short video to learn more about CHeT.

CHeT also helps to coordinate/conduct/manage a single site clinical trial/study, performing functions/services in project management, data management/analysis, monitoring, and more.