CRSP Application Instructions And Checklist

Center for Clinical and Translational Research Clinical Research Scholars Program

CRSP PROGRAM OVERVIEW

For the 2017 funding cycle, note that there have been significant updates to the Clinical Research Scholars Program structure, application, and the award terms and conditions. Please read this overview document thoroughly.

PURPOSE

The Clinical Research Scholars Program (CRSP) is an intensive mentored research career development program. The objective of the CRSP is to support the development of successful clinical, translational and outcomes researchers among junior faculty affiliated with Seattle Children’s. This goal is accomplished through a structured program of mentoring by dedicated CRSP Faculty, educational seminars, and financial support.

The CRSP supports career development in a wide range of research areas, including the mechanisms and treatment of diseases of children, as well as research related to areas such as patient safety and quality improvement. Proposed research must involve human subjects. Note: International projects will not be funded at this time. Specifically, research projects involving recruitment of participants, prospective collection of data or transfer of funds abroad are not allowed at this time.

The program is administered by Program Director Dr. Margaret Rosenfeld; Associate Program Director, Dr. Joseph Flynn; and the Center for Clinical and Translational Research (CCTR) Business Office. Colleen Lee is the Program Coordinator. Gloria Venegas is the CCTR Program Manager (Finance Contact).

PROGRAM DETAILS

Paths The CRSP has two paths, standard and intensive. Both paths are two years in duration, contingent on successful Year 1 completion. They share a common program of educational seminars and mentoring, but have different expectations of the Scholar, requirements for protected time and financial support.

Standard Path: The standard path is designed for Scholars with limited protected time and background in clinical research. A primary objective of the program is to mentor the Scholar in the preparation of a successful application for intramural or pilot project grants.

The standard path requires a minimum of 30% protected research effort and is primarily intended for faculty in the clinician-educator pathway. The CCTR provides salary support for 10% effort for two years contingent on successful year 1 completion, not to exceed $23,000 per year. The Scholar’s division/department/SCH provides support for the balance of the protected time. In addition, CCTR awards research support funds up to $10,000 annually to each Scholar for career or project development. Examples of appropriate uses of the research support funds include tuition for courses, biostatistical or bioinformatics consultation regarding study design, administrative support for grant preparation or publications, and assistance with IRB application preparation.

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Scholars are strongly encouraged to apply for pilot funding within their first six months in the program. Potential funding opportunities include CCTR and ITHS pilot project grants and the Academic Enrichment Fund (AEF).

At the completion of the program, Standard Path Scholars are expected to have 1) submitted abstracts and at least one manuscript; 2) presented at local or national meetings; 3) have grant funding as a principal investigator on a pilot or internal award or as a co-investigator on an extramural award.

Intensive Path: The intensive path is designed for Scholars with substantial protected research time and background in clinical, translational or outcomes research, and is primarily intended for faculty in the physician-scientist pathway. Applicants must enter the program with a well-defined research proposal.

The intensive path requires a minimum of 50% protected research effort. The CCTR will pay up to 25% of the Scholar’s salary for two years, not to exceed $58,000 per year. The Scholar’s division/department must provide support for the balance of the protected effort. In addition, the CCTR awards up to $20,000 annually to each Scholar for career or project development.

At the completion of the program, Intensive Path Scholars are expected to have 1) submitted abstracts and manuscripts, 2) presented at national meetings, and 3) to have successfully applied for a K-series or equivalent career development award.

Mentoring Mentoring is a critical component of the CRSP. A Scholarship Oversight Committee (SOC) is established for each Scholar, consisting of the primary and secondary mentors and an additional assigned CRSP faculty member. Each Scholar will meet with their primary and secondary mentor regularly. The primary mentor is identified by the Scholar, and the secondary mentor is assigned from the CRSP faculty. A division faculty member is invited if the primary and secondary mentors are outside of the Scholar’s division. The Scholar will have an SOC meeting within the first month of the award start date. The initial SOC meeting will evaluate the appropriateness of the project’s scope, establish a timeline, review the drafted budget submitted in the Scholar’s application, and make any adjustments to the project. The Scholar will continue to have SOC meetings semi-annually during the award period so that typically the scholar will complete five SOC meetings during the award period The primary and secondary mentors are expected to assist the Scholar with development of objectives and a training plan (as applicable), grant writing, project development and implementation. They review all grant applications, presentations and publications. The SOC tracks the Scholar’s progress. The Scholar submits a semi-annual progress report, reviewed by the SOC and shared with the division chief/department chair or designee. Clear written guidelines for mentors and Scholars are provided by the CRSP Directors. Advisory Statistician The advisory statistician will be responsible for providing scientific oversight and guidance for the statistical aspects of the study, including study design, data management and collection, monitoring and quality control, data analysis, and the presentation and dissemination of study findings. The advisory statistician will be assigned at the beginning of the award period and will participate in the discussions of the Scholarship Oversight Committee throughout the award period.

If the study team already includes a project statistician, the advisory statistician and project statistician could be fulfilled by the same person.

Educational & Works-In Progress Seminars CRSP educational seminars occur every four to six weeks. These seminars address the “nuts and bolts” of clinical, translational and outcomes research at Seattle Children’s. Topics include: working with the IRB to create a successful application, grant writing, budget management and oversight, introduction to Pediatric Clinical Research Center and CCTR core services, supervising and managing research staff. In addition, interactive works-in-progress seminars allow Scholars to present their work to peers and the CRSP faculty for thoughtful critique. Each scholar presents twice annually. Each scholar must submit an abstract for CCTR’s annual Science Day. All Scholars are required to attend CRSP seminars and works-in-progress. In addition, these educational offerings will be open and widely advertised to all interested faculty and fellows. Scholars may also choose to participate in a variety of other research training and career development opportunities, including courses in their research field, Institute of Translational Health Sciences (ITHS) seminars and workshops, the University of Washington School of Medicine (UWSOM) faculty development series, and the Seattle Children’s Hospital Fellows’ College.

Comparison of Standard and Intensive Paths Details Standard Path Intensive Path

 Full (primary) CCTR membership  Full (primary) CCTR membership  Junior faculty in clinician-educator  Junior faculty, generally in physician- Eligibility track* scientist track  Feasible research idea required  Well-defined research proposal required

Required Minimum 30% FTE (10% from CCTR up to Minimum 50% FTE (25% from CCTR up to protected time $23,000 salary & fringe per year and existing $58,000 salary and fringe per year and 25% and salary 20% protected time from match from division/department) support division/department/SCH)

Research/career Up to $10,000 annually Up to $20,000 annually development (e.g. tuition, travel, IRB fees, biostatistics, (e.g. tuition, travel, IRB fees, biostatistics, financial support research coordinator, etc.) research coordinator, etc.)

Duration of 2 years *Year 2 is contingent on successful 2 years *Year 2 is contingent on successful participation Year 1 completion Year 1 completion

 Educational seminars  Educational seminars Common  Works-in-progress seminars  Works-in-progress seminars components  Mentoring  Mentoring

Expectations of scholar at Investigator on pilot or internal award, or Co- K-series or equivalent independent career program PI on extramural award development award completion

*Faculty in clinician-clinician path may apply only if clear documentation by division chief of expectation and protected time for research

AWARD TERMS AND CONDITIONS

1. CRSP awards are intended to support the direct costs of research only. Indirect costs are not allowable costs for CRSP awards. CRSP awards should not be used to fund work occurring at an external institutions, such as a subaward contract. CRSP awards are not allowed to fund capital equipment purchases. 2. As a CCTR member and CRSP scholar, all future grant applications must be submitted through CCTR. 3. CRSP funds should not be used to hire new staff. If research coordinator support is required, CRSP scholars are encouraged to use the Research Coordinator Core (RCC). 4. The project research plan and budget must be finalized within the three months between the award announcement and the start date through meetings with the Scholar’s mentors, statistical advisor and the CCTR research navigator. The IRB application should be approved during this period as well. Funding amounts are subject to change based on finalized project adjustments. 5. It is expected that your research will be conducted within the timeline of and as outlined in your submitted proposal. Funds not expended in your budget by September 30, 2019 will be returned to Seattle Children’s Research Institute. 6. No-cost extensions and fund carry overs from year to year are not allowed for this program. 7. The recipient must ensure that, before the research commences and during the full Award Period, all the necessary national and local ethical, legal and human subjects and regulatory requirements are met to conduct the research, and any necessary licenses and approvals have been obtained. 8. You are required to inform the CRSP Program Awarding Official and Administrative Contact about receipt of extramural career development funding (direct salary support, project-related expenses) during your award period. Your CRSP award will be reviewed for budgetary overlap and may be subject to funding reduction. 9. Where the Terms and Conditions of the Award have not been observed, CCTR reserves the right to withdraw the remainder of the Award. 10. You are required to submit a semi-annual progress report and abide by the program expectations listed in the award letter. At the conclusion of your project, you are required to submit a final progress report to the Administrative Contact within 60 days of award end date. 11. Any publication or presentation of the results of research funded by a CRSP award should acknowledge the support from the Seattle Children’s Center for Clinical and Translational Clinical Research Scholars Program.

CONTACT INFORMATION Margaret Rosenfeld, MD, MPH Joseph Flynn , MD, MS Colleen Lee CRSP Co-Director CRSP Co- Director CRSP Program Coordinator 206-987-6547 206-987-2524 206-884-1331

Gloria Venegas CCTR Programs Manager (Finance Contact) 206-884-0596

FREQUENTLY ASKED QUESTIONS General Questions

1. Does the Div/Dept Letter need to be submitted with the LOI?

The Div/Dept letter does not need to be submitted with the LOI.

2. Are Fellows eligible for the CRSP award?

Fellows are eligible contingent that they have a faculty appointment that starts before the start date of the CRSP. If not yet appointed as a faculty member at time of application submission, then a letter from the division head/department chair should be supplied stating the date of appointment will commence at or before the time that CRSP funding begins (October 1). They can be appointed to acting Instructor, acting assistant professor or assistant professor.

3. Will my application be accepted if I have not submitted the Letter of Intent by the deadline?

No, full applications require the submission of an LOI.

Budget Questions

1. Does the CRSP grant provide funding for PI salary support?

Yes, the CRSP award will provide salary and fringe costs for the PI. For the Standard path, 10% funding is from CCTR and the Div/Dept/SCH continues to cover your committed 20% protected research effort. Together, standard path awardees are committing to 30% FTE for this project.

For the Intensive path, 25% is from CCTR and the Div/Dept matches 25% protected research effort. Together intensive path awardees are committing to 50% FTE for this project.

Both of these paths are subject to the Executive Level II salary cap of $185,100.

2. Why is the Standard Path capped at $23,000 and the Intensive Path capped at $58,000?

The amount of funding for salary and fringe is estimated based off the current federal Executive Level II salary cap of $185,100 plus a fringe benefits rate of 25.3%. If your salary is less than

$181,500 you may only charge the cost of your salary and fringe at 10% for the Standard Path and 25% for the Intensive Path.

3. Are subcontracts/subawards from other institutions allowed?

No, subcontracts/subawards to other institutions are not allowed. For example, we can not subcontract for work done at the UW or Fred Hutch. The program is to fund activities occurring at SCH/SCRI.

4. I want to take a course or attend a seminar prior to the award project period. Can I get an advance in my budget to pay for these expenses?

No, advances are not allowed for this program. The program only funds activities that take place during the funding period. If your seminar or course occurs before the project start date, then you will have to find alternative sources to fund those activities.

5. Am I allowed to travel to present at a conference or meeting?

Yes, if your travel is related to presenting and promoting your CRSP project, then it is an allowable budget item.

Mentor Questions

1. Is it a requirement that the primary mentor be faculty at SCH/UW? My mentor for the type of work that I would like to propose is located outside of the SCH/UW system or out of state?

It is strongly encouraged that your primary mentor be faculty at SCH/UW. Mentors outside of the SCH/UW system or out of state are subject to review by the CRSP co-Directors to ensure that all primary mentors understand the requirements and expectations of the program.

Other Questions

1. Are multi-center projects funded? Are international projects funded?

Multi-center projects requiring subcontracts are not funded. The CRSP does not allow subcontracts with external institutions. International projects will not be funded at this time. Specifically, research projects involving recruitment of participants, prospective collection of data or transfer of funds abroad are not allowed at this time.

APPLICATION DETAILS

Eligibility Criteria  Rank of acting instructor, acting assistant professor or assistant professor*  Primary member of the CCTR. Future grant applications must be submitted through CCTR  Standard path: Seattle Children’s based clinician-educator or clinician-clinician track*

 Intensive path: Seattle Children’s based junior faculty, generally in physician-scientist track  Applicant’s Division Chief must guarantee: o Standard: Minimum 30% FTE (10% from CCTR up to $23,000 salary & fringe maximum and your existing 20% protected time from division/department/SCH) o Intensive: Minimum 50% FTE (25% from CCTR up to $58,000 salary & fringe maximum and your existing 25% protected time from division/department)  A primary mentor must be identified, with willingness to mentor demonstrated in a letter of support  The applicant should propose career development in clinical, translational or outcomes research that includes enrollment of human subjects  The proposed budget must be for work at Seattle Children’s. No subaward contracts are allowed with external institutions.  International projects will not be funded at this time *Faculty in clinician-clinician path may apply only if clear documentation by division chief of expectation and protected time for research *If not yet appointed as a faculty member, a letter from the division head/department chair should be supplied stating the date of appointment will commence at or before the time that CRSP funding begins.

Letter of Intent

The purpose of the letter of intent is to help CCTR plan for the anticipated number and type of CRSP applications and yield quality finalized CRSP applications that have been fully developed. Letters of intent are due one month prior to the final application deadline. Final applications will not be accepted unless a letter of intent was submitted. Letters of intent are non-binding (i.e., applicants may choose not to submit a full application.

Application Review Process Applications will be evaluated by the CRSP Application Review Committee, comprised of members of the CRSP faculty. Prioritization will be based on:  Likelihood of career development plan to promote applicant’s success in stated research area  Likelihood of promoting the applicant’s academic status  Feasibility within a justified budget and allotted time All applicants will receive a summary of reviews from the review committee.

Mentoring Mentoring is a critical component of CRSP. A Scholarship Oversight Committee (SOC) is established for each Scholar, consisting of the primary mentor and a secondary mentor, who is an assigned CRSP Faculty member.  Regular primary and secondary mentor meetings  Initial SOC meeting within first month of the award start date to review and evaluate project Page 7 of 10 Center for Clinical and Translational Research Clinical Research Scholars Program

 Semi-annual SOC meetings throughout the duration of award period

Advisory Statistician  Provides scientific oversight and guidance for the statistical aspects of the study  Assigned at the beginning of the award period  Participates in the discussions of the Scholarship Oversight Committee (SOC) meetings throughout the award period  Advisory statistician and project statistician could be same person if the study team already includes a project statistician

Educational & Works-In-Progress Seminars  CRSP Educational and Works-in-Progress seminars occur every four to six weeks  Attendance is required for all scholars  Scholars must give two works-in-progress presentations a year  Scholars must submit an abstract for CCTR’s annual Science Day

Progress Reports Semi-annual progress reports are required to be submitted by the Scholar after each Scholarship Oversight Committee (SOC) meeting and should include the following components:  Attendance at required educational offerings  Presentation at works-in-progress  Participation in courses or other types of training  Grants in preparation, submitted, and/or received  IRB protocols in preparation, submitted, and/or approved  Presentations at local and national meetings  Manuscripts in preparation, submitted, and/or accepted for publication  Promotion activities if applicable

Key Dates RFA Released January 23, 2017 Letter of Intent March 31, 2017 Application Deadline April 28, 2017 Award Announcement By June 16, 2017 IRB Approved & 1st Mentor Meeting Completed Sept 30, 2017 Funding Begins October 1, 2017

APPLICATION INSTRUCTIONS

For the 2017 funding cycle, note that there have been major updates to the Clinical Research Scholars Program structure, application, and the award terms and conditions. Please read these instructions thoroughly.

1. All required application materials can be downloaded from the Apply to the CRSP webpage.

2. To view an example of a successfully awarded CRSP application, contact the CRSP Program Coordinator.

3. All applicants must complete a Letter of Intent prior to submission of their final application. The Letter of Intent must be submitted as one single PDF to the CRSP Program Coordinator by 11:59pm on Friday, March 31, 2017.

4. The CCTR Program Manager will provide assistance with the development of your budget and guide you through the internal sign-off process upon receipt of your LOI.

5. Application format specifications:

a. Font: Arial 11 pt regular b. Margins: Use at least one-half inch margins on all sides c. The application must be single-spaced d. Page limit: Follow guidelines for each section (see Application Checklist)

6. To assist with navigating the CCTR core services and resources available, applicants can find more information on the Core Services and Facilities web page or by contacting the CCTR Research Navigator for a consultation to assist with identifying available resources.

7. To request a biostatistics study design consultation, applicants must contact the Children’s Center for Biomedical Statistics (CCBS), at least 3 weeks in advance of the application deadline.

8. Final application materials must be submitted as one single PDF to the CRSP Program Coordinator by 11:59 pm on Friday, April 28, 2017.

Unsuccessful applicants may resubmit their applications for review one additional time unless the reviewers determine that the application does not meet the intent of the program. If the application is a resubmission of a previously unfunded CRSP application, please include a description of how the application has been modified in response to the previous review.

Letter of Intent Template – Limit to 2 pages – Deadline March 31, 2017

CRSP LETTER OF INTENT Applicant Information Name: Phone: Email: Mailstop: Academic Rank: Department/Division: CCTR Member YES Proposed CRSP Path Standard Intensive NO Is this an international YES – STOP HERE – International projects are not being funded at this project? time.*see specific details in RFA. Have you completed a CCBS YES, Project Number: NO consultation? Has your application been YES, when? NO reviewed by the IRB?

Title of Project

Project Overview (2-3 paragraphs)  Give an overview of the objective and activities involved.  Highlight why your approach is significant How will this project and program specifically benefit your career development?

Budget (2-3 paragraphs)  Statement about your division/department’s commitment (financial match) to your protected research time associated with the CRSP program.  General description of the project’s funding needs and total amount of request.

 Briefly describe the expenses associated with the project (For example: will you be using the core services (biostats core or the research coordinator core)? Will you be purchasing lab supplies? Will you be traveling to present at conferences related to this work? Will you be taking courses (tuition)?) I acknowledge that no-cost extensions and fund carry overs are not allowed for this program. By signing and submitting this application, the applicant and the applicant’s institutions agree that they have read and understand the Research Scholar Program Terms and Conditions and that, if the project is funded, it will be conducted in accordance with those terms and conditions, as well as any applicable institutional policies and/or government regulations.

Applicant Signature: Date: Electronic signature is acceptable