Contacts & Support

CAPS Administrative Specialist
Jill Anderson
anderson@epi.umn.edu
300 WBOB, EpiCH
612-626-8592

Multidisciplinary Advisory Committee (MAC Contact List)

CAPS Contacts

Shared Clinical Research Support Group:

To request assistance from the Shared Clinical Research support Group (SCRSG), complete the CAPS Resource Request Form and submit it to the Program Coordinator through the office of the Program Director.

Overview:  Increasingly, meaningful clinical research requires a multidisciplinary approach. Investigator needs range from collaboration on study design, protocol development, and data collection systems to staff selection, budgeting, legal consultation, and preparation of Institutional Review Board (IRB) applications. The Research Services Organization (RSO) in the AHC Office of Clinical Research (OCR) provides some of these services. SCRSG is intended to provide added assistance to the clinical research scholars.

Biostatistics Core: 
Study designs are increasingly complex requiring statistical input from the earliest stages. Staff is provided by the Biostatistics Center with a biostatistician assigned to each mentor team to provide advice on proposed design, sample size, and analysis.  Staff at the Biostatistics Center has wide expertise in clinical trial design, operation, data management, monitoring and reporting, data analysis, and presentation.  Dr. James Neaton coordinates biostatistical support for clinical research scholars.
           
Study coordination: Many issues of running a study, including forms design, data collection and quality control, are best understood by professionals who operate clinical trial coordinating centers and collect data under multiple designs and conditions. Staff will be provided by the Biostatistics Center with experienced study managers (usually with a graduate degree in statistics) working with the clinical research scholars to design data collection forms, pilot test those forms, construct database systems and help design quality control protocols.  These services and other study management expertise are readily available by assignment as needed.

Study Analysis:  Statistical analysis at the end of data collection in any study requires statistical consultation. Staff will be provided by the Biostatistics Center with the statistician mentor also serving in this analytic role, mentoring and helping develop manuscripts.  The Master's level staff in the Biostatistics Center will assist with data runs.

Budgeting: Experienced accountants/grants managers from the Research Services Organization (RSO), in the Office of Clinical Research (OCR), will review the budgets of new applications by the CR scholars.  They are knowledgeable regarding the regulations and requirements of granting agencies.
           
Study Staff:  Effective clinical research requires well-trained and skilled staff. The RSO, in the OCR, currently maintains a file of potential staff, including nurses, technicians and others, who are trained, experienced, and available to the clinical research scholars. In many cases, the GCRC may be the appropriate resource.  The RSO will aid in matching available staff to study needs and will assure the skills and qualifications of employees.

Clinical Pharmacology Center:  Many CR projects involve administration of pharmaceutical agents and the need to monitor the pharmacokinetics and pharmacodynamics of drugs.  In the conduct of CR, it is necessary to identify individuals with expertise designing drug administration regimens based on pharmacokinetic profiles to optimize the pharmacodynamic response. The College of Pharmacy at the University of Minnesota houses the "Center for Forecasting Drug Responses", the "Experimental and Clinical Pharmacology Core Analytical Laboratory" and the "Pharmacogenomics Research Group".  The staff and supporting infrastructure provide expertise in drug dosing regimen design, effect of pharmacogenetics on drug disposition and response as well as prediction of effect and monitoring of drug concentrations.  Dr. Timothy Tracy will coordinate collaboration with individuals trained in the design and conduct of pharmacokinetic and pharmacodynamic studies and in pharmacogenetics to ensure excellent design and data analysis.

General Clinical Research Center (GCRC): The National Center for Research Resources recognizes the need to have dedicated and sophisticated centers to support inpatient and outpatient CR. The GCRC is a major site for the conduct of multidisciplinary clinical research.  The mission of the GCRC is to promote, facilitate, and enhance the clinical research capabilities of students, scientists in training, and faculty of the AHC. The GCRC, directed by Dr. Elizabeth Seaquist, is staffed and equipped to provide clinical research inpatient and outpatient support.

Mentoring Core:  The background and skills of mentors and mentees vary.  Mentors' responsibilities and performance and the development of their mentees require regular evaluation.  Dr. Carole Bland conducts training workshops for clinical research scholars and their mentors to address mentoring skills, guidelines, and methods for tracking and evaluating career development progress. 

Office of the General Counsel:  Legal issues are increasingly associated with CR, including liability, consent and privacy regulations. Ms. Barbara Shiels, a lawyer with expertise in medical issues, serves as counsel to the AHC on clinical affairs and to the IRB.  She will provide consultation on the interpretation of regulations and signing of contracts (including private industry) for potential and manifest legal issues.

IND/IDE Assistance Program:  Increased oversight and regulation of the testing of drugs and devices requires technical advice. Mr. Harvey M. Arbit, Director of the IND/IDE Assistance Program, has expertise in industry and FDA related issues and will provide this consultation.

Scientific Writing: Dr. Anne Marie Weber-Main will conduct workshops as part of the Clinical Scholars Seminar.  Timely and skilled consultation and editing is available for grant proposals, abstracts, slide presentations, and manuscripts as well as practice sessions for oral presentations.