Clinical Research - Investigator

The Translational Research Office provides a single point of service to help facilitate and conduct clinical trials across the Banner - University Medical Center Phoenix, beginning at study development to closure. Services can be customized to individual investigators needs and eliminate silos. Our centralized resources help to maximize efficiency and ensure uniform standard operating procedures.

Clinical Data 

TReO's Clinical Data Team maintains electronic clinical trial documentation in REDCap, a secure and paperless environment that also maintains compliance with study related documentation requirements. This team can customize the design and development of a ePlatform to house both investigator initiated and sponsored clinical research studies. The team is trained in all compliance measures necessary to satisfy the University and Hospital Department/Divisions, College/University, and State/Federal reporting requirements.

TReO's Clinical Data Team maintains electronic clinical trial documentation in REDCap, a secure and paperless environment that also maintains compliance with study related documentation requirements. This team can customize the design and development of a ePlatform to house both investigator initiated and sponsored clinical research studies. The team is trained in all compliance measures necessary to satisfy the University and Hospital Department/Divisions, College/University, and State/Federal reporting requirements.

For data extraction requests please email PBC-GME-Research@arizona.edu or view more information on the clinical research data warehouse.

Funding

TReO's Clinical Research Billing Team is responsible for reviewing technical and professional charges for research studies to validate billing items and services related to clinical trial in compliance with the federal regulations, state laws, and contractual agreements. All metrics, financial updates and any payments for hospital, laboratory, and other external partners are managed by this team of professionals.

Search for Funding Opportunities, find more information on building a budget, or reach out to PBC-TREO-CR@arizona.edu with questions.
 

IRB Process and Required Documents

TReO's Regulatory Team can assist with transfer of protocol to IRB forms, creating informed consents and assents, and processing submissions. Members of the clinical team can assist with protocol and budget review, execution of research agreements and support communications between industry partners and internal and external research collaborators.

The University of Arizona IRB has added a ‘Getting Started’ overview of the steps and forms required for IRB submission.

1. Application for human research form.
   • Select the appropriate IRB Protocol form, based on the type of your study: prospective, retrospective, projects using external IRBs or, for Program Evaluations or Case Reports, the Determination for Human Research form. Click here for guidance on single IRB (sIRB) review for non-exempt human subjects research that involves multiple institutions funded or supported by federal agencies that have adopted the revised Common Rule. 
2. IRB Appendices.
   • In order to screen the medical record for enrollment and depending on the type of population or investigational product being studied, you may be required to complete an additional appendix for submission to the IRB.
3. Human Subject's Research Training.
4. Current CV for the principal investigator and co-investigators.
5. Download the most up to date template from the “Medical Consents” section. Use of these templates are required for any medical research interacting directly with patients at the Banner – University Medical Centers Tucson, South, or Phoenix campuses.
   • Informed consent forms are not required for retrospective chart reviews.
6. Data collection sheets or case report forms.
7. Conflict of interest.
   • To complete a Conflict of Interest Disclosure, select “eDisclosure” or “Submit COI or COC Disclosure” and complete any disclosures in “Draft” status.
8. Banner feasibility approval (RIF).
9. Learn more about conducting clinical research and non-research projects on Banner Campuses.
10. Other approvals required before IRB Submission (PDF).
11. Submit to eIRB.

If you have any questions, please email @email

Additional Resources for Investigators

Clinical Research Coordinator Team

The Clinical Research Coordinator Team is a centralized pool of clinical research coordinators that support studies across the College departments and divisions. Our coordinators are centrally located and trained in standard operating procedures to maintain consistency and compliance in research activities. They have expertise in study coordination, recruitment, and consenting of participants. As we have many Spanish speaking participants, TReO maintains a pool of bilingual research coordinators across all therapeutic areas. We are also fortunate to have a racially diverse clinical research team to support cultural competency efforts.

Regulatory Compliance Team

The Regulatory Compliance Team offers support and expertise to clinical research investigators in navigating the conduct of human subject research and compliance with regulatory requirements. Our team aids with IRB submissions and communications as well as investigator assistance in navigating Conflict of Interest (COI) disclosures and collaborating with the COI Office to implement COI management plans as required. Our Compliance Auditor conducts internal risk-based audits to assess compliance and determine focus areas for ongoing education. With a goal of facilitating compliance through a culture of continuous education, the Compliance Auditor also organizes monthly brown bag sessions that focus on clinical research practices and pertinent regulatory requirements and provides clinical research education content for Division Newsletters.

Please reach out to @email with any questions.

REDCap Clinical Data Team

The REDCap Clinical Data Team maintains electronic clinical trial documentation in REDCap in effort to support a more secure and paperless environment while maintaining compliance with study-related documentation requirements. The REDCap team offers support in project design and development for both investigator-initiated studies and sponsored clinical trials to enable an ePlatform for all clinical research studies. The team is highly knowledgeable in customized design, advanced branching, and form creation to optimize data collection for statistical analysis. Working in close collaboration with our faculty, resident/fellows, and clinical research teams, databases are customized to meet study protocol requirements and maintain compliance with local, state, and federal guidelines. In addition, the team is proficient in customizing reports within REDCap to satisfy Department/Division, College/University, and state/federal reporting requirements.

Please reach out to @email with any questions.

Biorepository Team

The Biorepository Team is a collaboration between our clinical research coordinating team and COM-P biobank services which operates under a Biobank Committee that is constituted to review project proposals and determine best allocation of resources to support translational research initiatives. In response to IRB-approved requests for the collection of blood, tissues and other fluids across hospital clinics and operating rooms, our teams huddle daily to review potential cases for collection and coordinate specimen collection, transport, and processing within strict timelines to ensure sample integrity. The biorepository lab team maintains a catalog of all available specimens and provides regular reports to the Biorepository Committee for oversight.

Clinical Research Billing Team

The Clinical Research Billing Team is responsible for reviewing technical and professional charges for research studies to validate billing for items and services related to clinical trials in compliance with federal regulations, state laws and contractual agreements. Our team also facilitates payment to our hospital, laboratory and other external partners providing research services. In addition, the team also provides quarterly reports to Department Chairs for financial updates.

Researcher Toolkit

Our easy-to-use Researcher Toolkit is designed for researchers to find quick and accurate answers to their immediate research needs.

Clinical Research Facilities

Clinical Research Facilities are conveniently located on campus of our B-UMCP hospital affiliate in the UArizona Clinical Research Suite at the Banner - University Medical Center Phoenix Medical Institute. The 4,101 square foot clinic is designed to provide a centralized hub of research resources to be available for all UArizona Phoenix-related clinical research needs. Services and resources are available below.

Resources	Services
4 private exam rooms IV infusion room Bariatric exam room 3 consult rooms Specimen processing room 2 vitals/phlebotomy stations 24-hour continuous temperature monitoring of study drug Clinical trial supply storage Specimen refrigerator -80° freezer Ambient and refrigerated centrifuges Automated blood pressure machines Height and weight scales	Study coordination Consenting Recruitment Assistance Study specific REDCap project development Regulatory Submissions IV administration for study infusion therapies Phlebotomy Biospecimen collection and processing PK monitoring EKGs Study monitoring/auditing

Please reach out to @email with any questions.

Brown Bag Lunchtime Trainings - Enhancing Clinical Research Skills

Join us for a series of informative and interactive brown bag lunchtime trainings focused on advancing your knowledge and skills in clinical research. Topics will range from research methodologies and data analysis to ethical considerations and the latest advancements in the field. Bring your lunch and engage in meaningful discussions that will contribute to your professional development in clinical research.

Time: 12:00-12:45 PM, Third Friday of each Month
Location: Remote via Zoom 

Contact for Questions and Recordings:
Jessica Winters, MLS 
Research Compliance Administrator
@email

2024 Schedule