# Administrative and Clinical Research Support Core

> **NIH NIH P01** · UNIVERSITY OF MINNESOTA · 2024 · $141,641

## Abstract

The broad objective of the Administrative and Clinical Research Support Core is to provide essential
administrative and clinical research support for the Projects and other Cores fundamental to the success of this
Program Project Grant. The administrative components of the Core focus on accounting, budgeting, regulatory
reporting and, most importantly, fostering team science by providing multiple opportunities for communication
between project and core investigators, external collaborators and the External Advisory Board members. Core
A will also facilitate clinical trial activation and execution and protocol specific training for the faculty and
research staff as well as nurse coordinators and advance practice providers working in the inpatient and
outpatient clinical units to maximize trial safety and integrity. To accomplish our objective, there are 4 specific
aims: Aim 1: Scientific Oversight is focused on facilitating communication between investigators in projects
and cores, arranging annual retreats for the Program’s team and annual meetings with an External Advisory
Board, composed of 4 renowned experts in the field of immune effector cellular therapy, and other key leaders
in the field on an ad hoc basis. The Programs’ leaders will continually seek areas of collaboration within and
outside the Program with investigators with expertise. Aim 2: Administrative and Financial Support is focused
on general accounting and fiscal support associated with the grant overall and individual projects and cores,
and assistance in the completion of progress reports. Aim 3: Clinical Oversight and Services is focused on
providing the support staff necessary for the preparation of clinical protocols and applications to regulatory
bodies, maintenance of clinical protocols, regulatory assistance for IND submissions and reporting, and
management of audits by internal and external agencies, and trial monitoring. Core A is also be responsible for
development of data management plans, case report forms and patient study treatment calendars, as well as
the collection of data from each of the clinical units, meeting the data management agreements with our clinical
partner, MHealth-Fairview. Aim 4: Faculty and Staff Education is focused on enhancing staff and faculty
education in the rapidly evolving field of cell, gene and immunotherapy. This will be accomplished through
standing seminars and grand rounds and other clinical program meetings. Here, we bring in outside leaders in
the field to present seminars and meet with senior and junior faculty and trainees, often leading to new
collaborations, magnifying our successes in translational medicine. Aim 5: Enrollment Optimization and
Enhanced Subject Education is novel unique approach for predicting and enhancing patient accrual and
subject understanding in support of the proposed clinical trials. These tools developed by investigators at the
University of Minnesota identify barriers to accrual and subject understan...

## Key facts

- **NIH application ID:** 10837853
- **Project number:** 5P01CA065493-27
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** John E. Wagner
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $141,641
- **Award type:** 5
- **Project period:** 1997-09-15 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10837853

## Citation

> US National Institutes of Health, RePORTER application 10837853, Administrative and Clinical Research Support Core (5P01CA065493-27). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10837853. Licensed CC0.

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