Pilot and Collaborative Clinical and Translational Research Grants

Pilot and Collaborative Clinical and Translational Research Grants

The CTSI Pilot Translational and Clinical Studies Program is supported by the Advancing a Healthier Wisconsin Research and Education Program (AHW REP) and the National Institutes of Health (NIH). For the 2017 cycle, the CTSI is set to fund 12 awards up to $50,000. These awards are intended to stimulate inter-institutional and interdisciplinary translational and clinical research within and among the CTSI partner institutions. These awards will promote best practice in team science research by supporting research teams with significant levels of interaction and integration.

Key Dates

  • Project start date for 2017 awards: April 1, 2017
  • RFA for 2018 Pilot cycle release date: July 1, 2017
  • Letter of Intent due: August 1, 2017
  • Application due in MCW Grants & Contracts Office: September 8, 2017
  • Application deadline: September 15, 2017



Summary: The fundamental goal of this funding path is to stimulate clinical and translational research among the institutions that comprise the CTSI of Southeast Wisconsin through meaningful collaboration and high quality team science. This award uses a multiple PI model to encourage inter-institutional and interdisciplinary collaboration, between clinical and basic biomedical scientists, social scientists, ethicists, engineers, biostatisticians, informatics specialists, and all members of clinical health care delivery teams.

Funds will be provided to:

  • Support new and promising clinical and translational projects across all disciplines, including annual special emphasis categories. 2017 special emphasis categories are Cardiovascular Research, Cancer Research, and Community-Engaged Health Disparities Research
  • Model best practices in team science research
  • Maximize scientific interactions of junior investigators with senior investigators;
  • Stimulate collaborative research between bench and clinical investigators within similar research areas;
  • Foster interdisciplinary and inter-institutional collaborations;
  • Support research in novel technologies and/or novel approaches and their applications to clinical practice and community health;
  • Support projects that will provide preliminary data for new extramural grant submissions.

This program is designed to advocate, facilitate, and foster the continuum of research from bench to bedside, and from bedside to community practice. In a sense, translational research focuses on discovery and the application of scientific findings into a real-world setting. It is the goal of the CTSI to diminish the barriers between institutions and disciplines, while encouraging novel approaches to solving complex health related problems. Ultimately, our goal is to improve health outcomes by creating new, bidirectional flows of information between our biomedical research enterprise and the community we serve.


This pilot award program funds clinical and translational research, defined as follows:

Clinical Research

The NIH defines clinical research in three parts:

  1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
  2. Epidemiologic and behavioral studies
  3. Outcomes research and health services research 1
Translational Research

The NIH defines translational research as: ‘Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science. 2

Applications should address one of the four T-levels on the CTSI Translational Continuum, based on NIH guidelines.

CTSI Pilot Award Program, Translational Track 1

T-1 Translation to Humans – Clinical Insights: Goal is to identify and analyze the effects of an intervention or relationship on the human condition or environment. The effect of an intervention, the effect of a relationship. Studies with human participants that yield knowledge about human behavior, physiology, pathophysiology and the potential for intervention (i.e. diagnoses, therapies, etc.).

T-2 Translation to Patients – Practice Implications: Goal is to identify and analyze the optimal effects of an intervention or relationship on the human condition or environment. The optimal effect of an intervention, or the optimal effect of a relationship.

CTSI Pilot Award Program, Translational Track 2

T-3 Translation to Practice – Goal is to incorporate into practice the optimal intervention or relationship. Phase 4 clinical trials – focus on post-marketing analysis. Includes health services research & community-based participatory research (dissemination, communication, implementation research).

T-4 Translation to Communities – Goal is to provide communities with the optimal intervention or relationship. Studies focusing on disease prevention through life-style and behavioral modifications. Documents “real-world” health outcomes of population health practices associated with improved disease prevention and reduced medical costs. Results in true benefit to society.

498 kBView the CTSI Translational Continuum
1 Glossary of Terms for Human Subjects Protection and Inclusion Issues, based on the 1997 Report of the NIH Director’s Panel on Clinical Research.
2 National Institutes of Health. RFA-RM-07-007: Institutional Clinical and Translational Science Award (U54) Mar2007.


General Instructions and Eligibility

  • Project proposals must be identified, and will be reviewed, from one of two Translational Tracks; Translational Track 1 projects incorporate either T-1 to T-2 on the CTSI Translational Continuum, and Translational Track 2 projects incorporate either T-3 to T-4 on the CTSI Translational Continuum. Applicants must select the CTSI Pilot Award Program Transitional Track that best describes their research. Please note: Research proposals that are only T0 are unable to apply. Research proposals that incorporate T5 (policy-level research) in addition Translational Track 1 or 2 are eligible to apply.
  • Projects will be funded at a level of up to $50,000. Institutional and departmental cost sharing to supplement these funds is highly encouraged (a letter of support from each PIs department chair is required).
  • Project duration will be 12 months or less.*
  • All projects must have an MCW PI. This award allows for, but does not mandate, a multiple PI model. In cases where a project has multiple PIs one must be from MCW. The other PI may come from another CTSI partner institution (UWM, MU, MSOE, CHW, BRI, VA, FMLH). All PIs must be fully vested in the project in both spirit and practice, and contribute actively on the project. All PIs must have at a minimum 5% effort on project. According to MCW corporate policy, the MCW PI will be primarily responsible for ensuring compliance with the scientific, safety, and ethical responsibilities of the grant award.
  • The MCW PI will have the additional expectation of managing the award through MCW internal eBridge system and through their department. The MCW PI will be responsible for all grant reporting and fiscal management, and will be the main contact for budget and reporting management.
  • All PIs and Investigators must be CTSI Members. To become a member, please complete the CTSI Membership Form.
  • All PIs must have full-time or full professional effort status to be eligible to serve as principal investigators (PIs). Adjunct and part-time faculty are not eligible to apply as a PI.
  • Applications must be inter-institutional. To fulfill the inter-institutionality requirement, the research team must include investigators from at least two of the five CTSI academic/research partner institutions (UWM, MU, MCW, MSOE, BCW) participating on a project. Independent investigators from our clinical partners (VA, FMLH, CHW) may meet the requirement only if they are not primarily employed by MCW. An example of this would be a CHW nurse researcher who are primarily employed at CHW and is a Co-PI or Co-I on a pilot project.
  • Community partners or investigators from other academic institutions would be welcomed additions to projects as Co-PIs or Co-Is, but alone do not meet the inter-institutional requirement. Please note, only primary employment will be used in determining institutional affiliation.
  • Faculty from the MU/MCW joint department of biomedical engineering should use their employment platform to determine institutional affiliation. However, two faculty alone from this department will not fulfill the inter-institutional requirement.
  • Furthermore, due to funding regulations, all projects must have an MCW PI or MCW Co-PI. Investigators that are interested in forming new collaborative relationships are encouraged to contact the CTSI Pilot Translational and Clinical Studies Program Director, Ramona Tenorio, PhD at 414-955-2537, rtenorio@mcw.edu.
  • If a previously submitted proposal has not received funding, a revised application may be submitted only once and must include a detailed response to concerns raised in the review of the original application.
  • All personnel must be identified prior to the start date to replace any “to be named” positions proposed in the application.
  • Investigators must provide proof that all regulatory applications (IRB/IACUC, etc.) are in pre-submission or approved by time of application. If applicable, proof of any Exempt Status must be provided. Applicants are encouraged to contact CTSI IRB Navigator, Sonia Maldonado-Schmidt: smaldonado@mcw.edu and MCW IRB Coordinator, Connie Byrne: cbyrne@mcw.edu at the time of application for assistance in managing IRB(s).
  • Untenured junior faculty member PIs are encouraged to apply.
  • PIs will be expected to comply with reporting and meeting requirements as a condition of receipt and continuation of funds. Non-compliance of final and/or annual reporting could result in the rescinding of funds by CTSI.

Budget Information

  • Funding under this RFA cannot be used as “bridge funding” for lapsed grants from any extramural source and is intended to be used for new projects.
  • CTSI funds cannot be used to supplant funds or resources that are available from other sources. For more information on supplanting, view the Non-Supplanting Policy on Infoscope. However, matching funding and opportunities to leverage CTSI funds to obtain other sources of financial support are encouraged.
  • No “indirect costs” may be charged for any CTSI funding, and no funds may be requested for general purchase of laboratory or clinical equipment greater than or equal to $3,000. For more information on allowable expenses, please view Advancing a Healthier Wisconsin Research and Education Direct, Indirect, and Unallowable Costs.
  • Faculty salaries are subject to the NIH salary cap (FY15 Executive Level II salary cap of $181,500).

* This program has an accelerated nature and only a 12 month funding period. If your project requires working with federal agencies such as NIDA, FDA (e.g., IND, IDE applications) or pharmacological agreements (e.g., clinical trial agreements, material transfer agreements), you must contact the CTSI Pilot Translational and Clinical Studies Program Director, Ramona Tenorio, PhD at 414-955-2537, prior to applying.

Special Emphases

2017 Special Emphases

Cardiovascular Research, Cancer Research, and Community-Engaged Health Disparities Research are special emphasis categories for 2017. Additional review weight will be applied to research in these respective areas.

Novel Approaches and Technologies focus on the development of new and innovative technical resources. Projects that involve design and development of novel approaches or technologies which are accessible and efficient to monitor health or deliver care in real-time are highly encouraged to apply. Additional review weight will be applied to research incorporating novel approaches or technologies. Selected proposals are intended to increase the efficiency and/or rigor of multidisciplinary clinical and translational research.

Review Criteria

Review Criteria

To ensure that the results of scientific research will be used to directly benefit human health, proposals in all disciplines relevant to biomedical investigation will be considered for funding. Criteria for funding of any proposal include: 1) the clear potential to directly translate anticipated results into improved preventative health, diagnostics, therapeutics or health outcomes for our southeast Wisconsin community; and 2) the potential for proposed studies, when completed, to generate extramural funding.

An Intent to Apply Form will be reviewed for each intended application by the CTSI Pilot Translational and Clinical Studies Program. Projects meeting Intent to Apply standards will be sent an email with a personalized link to proceed to a full application.

The CTSI Pilot Award Committee (PAC) will initially review all applications for technical feasibility and compliance with above requirements. CTSI PAC is comprised of at least one member from each of the partner institutions (MCW, MSOE, MU, and UWM), to ensure equitable representation of all the CTSI partner institutions.

All applications will go through peer- review, an in-person panel review, and a post-panel review.

Projects are reviewed based on their selected Translational Track. Specific review criteria for each Translational Track can be viewed in the documents below.

341 kBTranslational Track 1 Review Guide and Score Sheet 286 kBTranslational Track 2 Review Guide and Score Sheet
Terms & Conditions

National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS)
Terms and Conditions for CTSI Pilot Award Projects

  • In accordance with section 479(b) of the Public Health Service Act (as amended by the Consolidated Appropriations Act, 2012, Public Law 112-74), NCATS is authorized to use fiscal year 2015 funds to provide infrastructure and resources for all phases of clinical trials research, but can only support clinical trials through the end of Phase IIA (with the exception of certain clinical trial activities involving treatment of a rare disease or condition). However, all phases of clinical trials may utilize infrastructure and resources provided through the CTSA.


  • The complete clinical research protocol and consent document. If the clinical research protocol is considered an amendment to a parent protocol, include information explaining exactly what is being supported by NCATS pilot funding. If the entire parent protocol is included in the submission, that portion which is supported by NCATS funding should be clearly labeled as such.
  • If a clinical trial is proposed, product information, such as the clinical investigator brochure or package insert or description of the device shall be included. Documentation that an IND or IDE has been obtained or letter from FDA that the study is IND exempt or IDE has been waived.
  • Description of risk, protections, benefits and importance of the knowledge to be gained by research involving human subjects.
  • Inclusion Plans for Women, Minorities, and Children, if applicable
  • Targeted Enrollment Table or Inclusion Data Record (IDR), if applicable.
  • Data and Safety Monitoring Plan (DSMP) and Board (DSMB), if applicable.
  • Certification that the pilot awardee and any Key Personnel directly involved in the study have taken appropriate education in protection of human subjects.


  • No funds in this award may be used for any research involving human embryonic stem cells (hESCs) until the grantee has submitted to NIH information on the specific, approved hESC line(s) that will be used from the NIH Human Embryonic Stem Cell Registry (http://grants.nih.gov/stem_cells/registry/current.htm). While the Registry will include lines pending review; only those hESCs listed on the Registry as eligible for NIH funding may be used in this award. Information should be submitted from an Authorized Organizational Representative to the assigned Grants Management Specialist noted below.
  • The grantee may use only those hESCs that appear on the NIH Human Embryonic Stem Cell Registry as eligible for NIH funding (http://grants.nih.gov/stem_cells/registry/current.htm) and in accord with any restrictions placed on the use of those lines. For more information on the requirements regarding use of Human Embryonic Stem Cell (hESC) lines, see: http://stemcells.nih.gov/info
  • It is understood that no clinical research trainee or mentor will be permitted to work on any project involving live vertebrate animals or human subjects that has not been approved by the IACUC and/or IRB, as appropriate.
  • No funds may be drawn down from the payment system and no obligations may be made against Federal funds for research involving human subjects by any site engaged in such research for any period not covered by both an OHRP-approved Assurance and an IRB approval consistent with 45 CFR Part 46. See “Human Subjects Protections” Part II, Chapter 4 (http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf) for specific requirements and grantee responsibilities related to the protection of human subjects.
  • In accordance with the NIH’s policy on data and safety monitoring of clinical trials NIH Grants Policy Statement (Part II, Chapter4 http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf) the grantee must submit its data and safety monitoring plan to the NCATS for review and approval.
76 kBAdditional Terms and Conditions for CTSI Pilot Award Projects

Clinical and Translational Science Institute

CTSI seeks to promote the highest quality of human subjects research, therefore as part of the post award process, pilot projects that were ranked 4.5 or higher on the NIH Likert scale, will be analyzed for trends in deficiencies. The purpose of this analysis will result in generalizable knowledge, as required by NCATS, and be used for educational training opportunities to enhance translational science and investigator knowledge.

Note: This quality improvement initiative will have no impact on the CTSI Pilot Review process. All information shared as educational material will be de-identified. For any questions or concerns, please contact the project lead, Amit Gode, MD, MCW CTO Director at agode@mcw.edu.

How to Apply

How to Apply

Submission Details

The online Intent to Apply Form must be completed and received 8/12/2016, 11:59pm CDT.

All applications must be received for CTSI administrative approval via invitation by 9/30/2016, 11:59pm CDT. Submissions by any other means will not be accepted.

Elements & Requirements of the Application

  1. 2017 CTSI Pilot Award Proposal Form
  2. Budget and Budget Justification Form (1 per partnering institution/agency)
  3. NIH Biographical Sketch (all PIs and all Co-Investigators; limit 5 pages per individual)
  4. CTSI AHW Goals Alignment Form
  5. MCW Faculty Cost Sharing Commitment Form (if applicable)
  6. Letter of Support for project from PI(s) Department Chair (if required by your institution)
  7. Letters of Support from each Co-Investigator to the PI(s)
  8. AHW Non-Supplanting Attestation Form (all PIs, all Co-Investigators, and any applicable partnering institutions and agencies are all required to complete and submit AHW Non-Supplanting Attestation Forms). Note- this will only be collected for funded applications. 
Download the Required Files

Please download and complete all of the documents prior to completing full application.

All applications must be routed through eBridge and must be received by the Office of Grants & Contracts (GCO) no later than 5 business days before the submission deadline in this RFA. Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the Office of Grants & Contracts.

Additional Requirements by Institution

For MU investigators, the application must be registered via the routine Proposal Registration process with the Office of Research and Sponsored Programs prior to submission. This process is required for proposals in which MU is the prime applicant and those for which MU is the collaborating applicant receiving funds. Remember that Marquette requires that a signed institutional letter of intent is in hand from all sub-awardees or collaborating institutions who will be receiving funds (i.e. MCW, UWM, MSOE, etc.) from a grant in which MU is the prime applicant prior to submission. Please contact an ORSP staff member early in your application preparation process as we can assist with forms, budget formulation, proofreading, securing sub-award letters of intent, etc.

For UWM investigators, full applications must be routed using the WISPER system and approved by the Office of Sponsored Programs prior to submission to MCW. UWM applicants with new collaborators must process the sub-award within the MCW timeline. Letters of intent do not require a WISPER record.

For MSOE investigators, please contact Tom Bray, Dean of Applied Research, 277-7416 or bray@msoe.edu.

AHW REP and NIH Funding Acknowledgment: Important Reminder – Please acknowledge the AHW REP and NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement. Please see AHW REP website for Acknowledgement Policy

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

Zablocki VA Medical CenterFroedtert HospitalMedical College of Wisconsin Childrens Hospital of WisconsinBloodCenter of WisconsinUniversity of Wisconsin - MilwaukeeMarquette UniversityMilwaukee School of Engineering