Crafting a compelling grant application involves not only knowing what resources are available to the PI and the research team but also knowing how to access them. These tools of the trade are invaluable components of research, and a critical part of CTSI’s mission is to facilitate the use of these resources. When in doubt, the easiest way to access them is through one of the CTSI research facilitators.
Directory of Research Resources
The Directory of Research Resources provides a listing of key research offices, centers, institutes, and programs at the University of Pittsburgh and serves as a resource of information about support services, policies, procedures, and regulations related to the conduct of research. The directory—compiled and maintained by the Office of Research, Health Sciences and the Office of Clinical Research, Health Sciences—is organized alphabetically and categorically and includes contact information for each entry.
Clinical and Translational Research Centers
The Clinical and Translational Research Centers (CTRCs) provide investigators with the resources needed to conduct intensive, safe, controlled, state-of-the-art, inpatient and outpatient clinical research studies. These resources include facilities, staff, and equipment that enable investigators to engage directly with research participants in a wide range of patient-oriented procedures, including, but not limited to, blood draws, physical exams, drug safety assessments, clinical trials, imaging studies, and pharmacokinetic studies. The aims are to meet investigators’ needs and to reduce barriers to effective clinical research. There are six active CTRCs in the University of Pittsburgh/UPMC system, each of which serves a different patient and researcher population.
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The Montefiore CTRC
provides resources for clinical studies in medicine and surgery at its newly remodeled,
state-of-the-art research facility and offers specialized research nutrition staff consultations and
skilled nursing staff training.
Contact: Rosemary J. Sabol, MBA
Administrative Director
412-648-6691 or sabolrj@upmc.edu -
The University of Pittsburgh Cancer Institute
CTRC, the newest center, facilitates collaboration between basic and clinical researchers and
provides resources for research in cancer prevention, detection, diagnosis, and treatment.
Contact: Pamela Sisco, MSN, RN, OCN
Nurse Clinician
412-623-4610 or siscopc@upmc.edu -
The Magee-Womens CTRC is a resource
for investigators conducting clinical research in women’s health issues, including pregnancy
complications, breast and gynecological cancers, autoimmune diseases, and conditions of aging.
Contact: Patricia Barcic, BSN, RN
Administrative Director/Nurse Manager
412-641-5349 or pbarcic@mail.magee.edu -
The Neuroscience CTRC,
formerly known as the Clinical Neuroscience Research Center, focuses on clinical neuroscience,
psychiatric issues, and sleep and circadian rhythms research.
Contact: Dawn Stocker, MPA
Administrator
412-246-5294 or stockerdg@upmc.edu -
The Pediatric CTRC,
based at Children’s Hospital of Pittsburgh of UPMC, focuses on childhood illnesses and supports children
and families participating in research initiatives.
Contact: Lynnette Orlansky
Administrative Director
412-692-5573 or lynnette.orlansky@chp.edu -
The Braddock CTRC based at UPMC Braddock, focuses on minority health and disparity issues.
Contact: Dawn Stoker, MPA
Administrator
412-246-5294 or stockerdg@upmc.edu
An additional CTRC is being established in conjunction with the University of Pittsburgh School of Dental Medicine (oral health, genetic sampling and repository).
For more information about the CTRCs, including how to apply for services, required training, administrative support, technical support, frequently asked questions, and more, click here.
Boilerplate Language
If your investigation requires access to or use of specialized research facilities, you’ll need to include a description of these resources in your application. Boilerplate language is a standardized description of a research facility and the services it provides. Use of boilerplate language obviates the need for individual researchers to come up with their own wording and provides the evaluating agency with a complete, accurate, and consistent description of the facility. To obtain the most recent up-to-date boilerplate statements for any University of Pittsburgh/UPMC research facility to use in your grant application, contact a CTSI research facilitator or complete a service request form.
Study Design and Statistical Analysis
Your study methodology—that is, developing the right study design, collecting the right data, and conducting the appropriate statistical analyses—is arguably the most critical part of your entire grant application and investigation. Data are meaningless if haphazardly collected or incorrectly interpreted. Will you be looking at the prevalence or the incidence of a particular condition in your study? Will you match subjects with normal controls in a retrospective analysis, or are you proposing an intervention with follow-up over time? Depending on the nature of your investigative question, these are just a few of the important questions to consider in optimizing your study design. Especially if your clinical trial involves human subjects, a preliminary statistical power analysis will help you determine the minimum number of subjects you will need to recruit in order to yield a statistically significant result. The more careful thought you can invest in developing a rigorous study design at the application stage, the less likely you will be to encounter headache and frustration in the later stages. For information or assistance in developing the right study methodology for your project, contact a CTSI research facilitator or complete a service request form.
Informatics and Information Technology Resources
Informatics concerns the science and processing of statistical information and information systems. For studies that amass very large data sets, powerful software technologies can aid the investigator in storing, processing, accessing, and navigating “the numbers.” Pitt’s Department of Biomedical Informatics has innovative technology tools for managing the administrative and clinical functions for the collection and analysis of research data. For information on the informatics resources available to you, contact a CTSI research facilitator or complete a service request form.
Pre-review of Regulatory Issues
All Pitt research involving human subjects requires formal approval from the University of Pittsburgh Institutional Review Board (IRB). Depending on the nature of the study, other regulatory agencies, such as the Institutional Animal Care and Use Committee (IACUC) or the Institutional Biosafety Committee (commonly referred to as the “rDNA Office”), may also need to be involved. For information about the review process for the IRB or any of the other regulatory agencies, see the Application Preparation Timeline section and contact a CTSI research facilitator or complete a service request form.
Data Safety and Monitoring Board Issues
For studies that generate blinded data, present any more than minimal risk to subjects, or involve gene transfer methodology, progress reports must be submitted by the PI to the Data Safety Monitoring Board (DSMB) at the time of IRB continuing review, upon request by the IRB or sponsor, or in case of adverse events per sponsor and IRB guidelines. The DSMB, a subset of the IRB, is composed of a limited group of clinical research experts, biostatisticians, and physicians who review study data at specified intervals to determine the safety and efficacy of a study. The responsibility of the DMSB is to ensure the safety of participants, to ensure that they are adequately informed of risk, to assess the efficacy of the intervention, and to report adverse findings to all sites as needed. For assistance in ensuring that your study adheres to the safety protocols established by the DMSB, contact a CTSI research facilitator or complete a service request form.
Participant Recruitment Resources
Participant recruitment is one of the most daunting tasks of a clinical trial. CTSI has developed a number of strategies to recruit and retain participants in research studies at the University of Pittsburgh. One of these initiatives is a Research Participant Registry, which is a database of individual volunteers who are interested in participating in research studies that match the health conditions identified in their personal medical information profiles. PIs may list their studies with the registry. In a computer-generated process based on participant preference and study model design, participants are notified by mail of potential study “matches” on a quarterly basis. Participants who agree to submit to and pass an initial screening are then referred to the PI for enrollment in the study. For more information about the Research Participant Registry or how you can list your study, contact the Research Participant Registry office at 412-864-3478 or researchregistry@hs.pitt.edu.
Grant Application Resources from the Office of Research, Health Sciences
The University’s Office of Research, Health Sciences (OORHS) Web site offers a wealth of grant application resources:
- Boilerplate descriptions (updated annually) of University offices, facilities, and other research resources for use in a grant application
- Historical NIH funding data for the University that can be used to emphasize Pitt’s past success in obtaining grants for particular research areas or from particular NIH institutes
- Application Repository to Help University Researchers (ARTHUR), a collection of successful federal grant applications written by investigators from the University’s six health sciences schools that target various funding mechanisms
- Links to online examples of various types of model grant applications as well as the following grantsmanship resources:
- Writing and Grantsmanship Resources (OORHS)
- Grant Application Preparation Resources (OORHS)
- All About Grants Tutorials (NIH)
- New and Early Stage Investigator Policies (NIH)
- An Evidenced-Based Guide to Writing Grant Proposals for Clinical Research (Annals of Internal Medicine)
- Resources for the Development of Early-Career Scientists (HHMI)
- Factual information about the University of Pittsburgh and its six health sciences schools that can be used in grant applications to describe the research enterprise here
