Clinical Research Scholars Program (CRSP) Award

Transcription

1 Clinical Research Scholars Program (CRSP) Award POLICIES AND GUIDELINES WITH LETTER OF INTENT (LOI) April 14, 2016 PLEASE NOTE: FULL APPLICATIONS WILL ONLY BE ACCEPTED FROM APPLICANTS WITH AN APPROVED LETTER OF INTENT (LOI) Cystic Fibrosis Foundation 6931 Arlington Road, Suite 200 Bethesda, MD Grants and Contracts Office (301)

2 I. THE CYSTIC FIBROSIS CLINICAL RESEARCH SCHOLARS PROGRAM AWARD OVERVIEW Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) and the Therapeutics Development Network (TDN) announce the Cystic Fibrosis Clinical Research Scholars Program (CRSP) Award. The CRSP Award will enable outstanding early-career pediatricians and internists to enhance their clinical research proficiency and to develop the necessary clinical research capabilities to become independent investigators who formulate and lead multi-center, clinical research studies. Awards will provide early-career faculty the opportunity to undertake up to three years of support (up to 20% FTE per year) for their clinical research training, and the initiation of a career focusing on multi-center clinical investigations, including observational, translational and interventional clinical research. Year I - The first year of the program will consist of hands-on, in-person clinical research training at the TDN Coordinating Center in Seattle, Washington, as well as an interactive, distance-training period at the candidate s home institution with mentorship by a program mentor and an academic institution mentor from the investigators home institution. Components of the program include serving as a member of the TDN Protocol Review Committee, writing or rewriting the candidate s research proposal to meet TDN protocol standards and developing study materials, conducting a secondary data analysis project (optional), and presenting the candidate s work at the annual TDN Spring Meeting. Years II and III - The second and third years of the program will provide the opportunity to further develop skills in multi-center clinical research by continuing the work started in year 1 along with continued mentorship by program and academic institution mentors. Additionally, in the second and third years, candidates will serve as an ad-hoc member of the CFFT Clinical Research Committee, have a larger role on the TDN Protocol Review Committee, serve as a Co-Investigator on a TDN study (as available), as well as be exposed to other facets of TDN multi-center clinical research such as the DSMB and consulting with Industry partners. Program Learning Objectives Provide early career investigator candidates with a rigorous background in the operational aspects of the conduct of multi-center CF clinical trials Provide mentorship for project development in conjunction with the candidate s home institution Give candidates training in regulatory aspects of drug development and clinical trial conduct Give candidates experience in developing a formal protocol and study materials for a multi-center CF clinical trial Provide candidates with insight regarding common statistical issues and clinical trial design components critical to successful multi-center CF clinical trials Give each candidate the opportunity to do secondary analysis of data held in the CFFT TDN Coordinating Center data repository in support of their research goals Provide support to translate the candidate s program project into a presentation, publication, or multicenter grant application Provide the opportunity to serve on the Protocol Review Committee (PRC) during the program Provide the opportunity to serve on the Clinical Research Committee (CRC) during the program II. ELIGIBILITY Candidates eligible for the program will have completed specialty fellowship training (as an MD or DO) and have an academic faculty appointment at their home institution at the time of application. Priority will be given to early career faculty who are within 7 to 10 years of completing their fellowship training. In some cases, consideration will be given to mid-career faculty who are making a transition in their career/research focus and for which this program would provide the training necessary to lead multi-center trials. Prospective candidates will need to demonstrate sufficient commitment to and experience in CF clinical CFFT Clinical Research Scholars Program (CRSP) Award, April

3 research to support the rationale for participating in this program at this time in their career. The optimal candidate will be one who has an ongoing or upcoming single-center clinical research study or trial that can be directly applied to program objectives. Candidates with other career development awards should assess the compatibility of this program with the stipulations of these awards (examples being K-awards, others). Prior and current recipients of other CFF Fellowship awards (e.g. Shwachman or Leroy Matthews) are eligible as long as there is no overlap in the timing of the awards (i.e. other award funding must be completed by the anticipated start date of the CRSP award). A maximum of two program scholars will be accepted each year. The scholars will begin the program at the same time and will together attend two one-week sessions based at the CFFT TDNCC (in Seattle, WA). Prospective candidates will be required to outline a mentorship plan and identify mentor(s) at their home institution who will continue in this role after they complete this program. Ideally, a mentor (or mentors) along with a mentorship plan will have been in place in the year before program participation begins. Candidates must be citizens of the United States or have obtained permanent residency prior to the time of application. Candidates must be an investigator at a domestic academic institution. III. GENERAL TIMELINE A Letter of Intent (LOI) must be submitted and approved prior to submitting a full application. LOI Deadline May 1, 2016 CRSP Review Committee Meeting (LOI) First week of May 2016 Applicants Invited To Submit Full Application May 9, 2016 Full Application Deadline June 24, 2016 CRSP Review Committee Meeting End of July 2016 Applicant Notified/Award Letter Issued Mid-August 2016 CRSP Start Date November 1, 2016 Face-to-Face Meetings at TDNCC in Seattle November 14-18, 2016 and July 24-28, 2017 IV. SUBMISSION INFORMATION FOR LETTERS OF INTENT (LOI) Applicants must submit a LOI and a copy of their CV for review by the CRSP Application Review Committee. The LOI is limited to one (1) page and must include the following information: 1. Name of Applicant 2. Name of Sponsoring Institution 3. Name of Sponsor (Academic Mentor) at Institution 4. A description of the Applicant s interest in the CRSP Award, and how this award will help the applicant meet his/her career goals. 5. A description of the Applicant s and Mentor s working relationship, and the Applicant s qualifications to conduct the proposed project. 6. A brief description of the proposed study or research plan. The LOI must be submitted electronically to TDNCC@seattlechildrens.org by Sunday, May 1, Please put CRSP Award LOI in the subject line. All Applicants will be notified by May 9, 2016 of the CRSP Review Committee decisions, and selected Applicants will be invited to submit a full application. CFFT Clinical Research Scholars Program (CRSP) Award, April

4 V. SUBMISSION INFORMATION FOR FULL APPLICATIONS A Letter of Intent (LOI) must be submitted and approved prior to submitting a full application. APPLICATION DEADLINE: June 24 th at 5:00pm (Eastern) Applications must be submitted online at ProposalCENTRAL: CFFT reviews applications electronically, and only the documents submitted online will be reviewed. The Face Page (system-generated upon submission of the application) must be signed and ed to awards@cfft.org by the same deadline. Late applications will not be accepted. VI. REQUIREMENTS Environment Applications will be accepted from individuals at domestic academic institutions with: 1. A strong, established CF-related research and clinical training program 2. A commitment and capability from senior faculty at the candidate s home institution to provide guidance and mentorship to candidates in the development of independent careers as cystic fibrosis researchers and clinicians. The environment must be one which stimulates and increases interaction and opportunities for the candidate to lead multi-center clinical trials. Evidence of the institution s commitment to the candidate's research and development must be provided. Sponsor Each candidate must identify a primary Sponsor (academic mentor) from their home institution who is recognized as a physician-scientist with experience in training independent investigators, and who will provide guidance for the awardee's clinical and research development. The primary Sponsor must be committed to continue this involvement through the individual's total period of training (Years 1-3) under the award. Duration and effort This is a non-renewable award for up to three years of salary support. All funds must be used on behalf of the original candidate. Support is divided into three distinct years that relate to the individual's progress in becoming an independent investigator. It is required that 20% effort during the award be devoted to the research and the Clinical Research Scholars Program. Minimum Requirements Awardees must agree to inform the CFFT annually for a period of five years subsequent to completion of the award about academic status, publications, and research grants or contracts received. In addition, all awardees and institutions must comply with CFFT award policies and Terms and Conditions. VII. BUDGET Allowable Costs Individual salary compensation requested from CFFT may not exceed 20% of the NIH salary cap ($185,100 in 2016) or $37,020 per year for up to three years. In addition, the award will cover standard institutional fringe benefits for that salary. Salaries will be in compliance with institutional guidelines and can be supplemented by the institution. Sponsor support is not provided. CFFT Clinical Research Scholars Program (CRSP) Award, April

5 Travel support will be provided for the following meetings required as part of the CRSP Award: Year 1 (Up to $10,000 may be requested) - TDNCC Practicum, November 14 18, 2016 and July 24 28, 2017 in Seattle, WA TDN Spring Meeting, April 3-4, 2017 in Nashville, TN NACFC Meeting - TDNCC in-person meeting with TDNCC Mentor in Seattle, WA Year 2 (Up to $5,000 may be requested) TDN Spring Meeting NACFC Meeting - TDNCC in-person meeting with TDNCC Mentor in Seattle, WA Year 3 (Up to $3,000 may be requested) TDN Spring Meeting NACFC Meeting Indirect Costs CFFT does not provide indirect costs for physician-scientist training awards. VIII. REVIEW AND AWARD The CRSP Application Review Committee will evaluate all applications and make recommendations to CFFT and the Board of Trustees for final approval and funding. CFFT considers the availability of funds, the priority score awarded each application, and the committee recommendations when determining awards. Review Criteria for the Clinical Research Scholars Program Award: The Candidate Competence in clinical activities and potential for a career in multi-center clinical research trials Commitment to a research career related to CF The Sponsors Accomplishments in clinical research related to CF Commitment of the primary Sponsor for the duration of the candidate's development and research plan Experience of the Sponsor in training individuals for multi-center clinical research The Environment Presence in the institution of highly trained faculty in clinical research related to CF Institution's CF research and research training programs Institution's commitment and ability to provide the opportunities necessary for the clinical and research career development related to CF The institution s commitment to the faculty member s overall career development Candidate Project Proposal Feasibility and value of the proposed plan Clinical research merit of the proposed research Ability of the proposed plan to develop the candidate into a multi-center clinical research investigator Relationship to candidate's career development Payments Payments for successful applications are made quarterly in arrears to the Sponsoring Institution and not to CFFT Clinical Research Scholars Program (CRSP) Award, April

6 the individual awardee. Payments are subject to various contingencies, such as signed assurances, progress reports, and financial reports. IX. APPLICATION COMPONENTS Font: Times New Roman 12 or Arial 11 font. Standard Margins. Each section should be numbered individually. Once all documents are uploaded to Proposal Central, the system will compile them into one PDF file in the correct sequence. Application Deadline: June 24, 2016, 5:00pm (Eastern Time) Submit online at Proposal Central: a signed Face Page to awards@cfft.org by the same date. Register at ProposalCENTRAL if you are a first time user. If you have registered before, and cannot remember your password, click on the Forgot Password button. The landing screen lists grant opportunities, but note you must log in first. This RFA is by invite-only, so if your LOI has been approved a full application will be started for you. Upon logging in please select Manage Proposals and then go to the In Progress tab and you will find the started application. Select Edit next to the application title to begin your application. Application Sections are listed in the gray menu box to the left of the screen. The sections need not be complete sequentially. You may stop at any point in the application, each time remembering to SAVE your entries, and return to continue, revise, and upload until you have actually hit the SUBMIT button. When you log in to continue, click on the blue tab, MANAGE PROPOSALS, then the IN PROGRESS tab, and then the Edit button next to your application title. Do not start a new application. Download the templates and instructions in Section 2. Complete the forms offline and upload in Section 10. Complete Section 3 if you wish to designate access to another individual, such as an assistant or Co-PI who has registered on ProposalCENTRAL. Enter the full name and address and in the Permissions column, then use the pulldown menu to select the type of access desired. A. Face Page (System-generated) The Face Page is populated automatically with data entered (applicant s name, institution, title of application, etc.) in the online application. After you hit the Validate button for your completed application, you will be able to download the face page. The Face Page must be signed by the Principal Investigator and Authorized Institutional Official. Scan and the signed Face Page to awards@cfft.org by the deadline. No hardcopy is required. B. Abstracts, Summary of Relevance, Key Words Lay Abstract In the space provided online, enter or paste a statement of no more than 250 words (up to 2,000 characters max, including spaces) explaining the subject of the research proposal and its relationship to CF. This statement will be used to inform the non- scientific departments of CFFT and the general public of the nature of this work. Do not include proprietary information. Scientific Abstract In the space provided online, please provide a statement of no more than 250 words (up to 2,000 CFFT Clinical Research Scholars Program (CRSP) Award, April

7 characters max, including spaces) explaining the subject of the research proposal and its relationship to CF. This statement will be used to inform the scientific community of the nature of this work. Do not include proprietary information. Summary of Relevance All applications are reviewed and scored not only on scientific merit but also on relevance to CFF s mission. The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment, and ensuring access to high- quality, specialized care. Provide a statement of no more than 250 words (up to 2,000 characters max, including spaces) summarizing the relevance of the proposed research to the health and well-being of CF patients, for a scientific audience who may or may not have a background in the subspecialty of the proposed research. Keywords From the lists of options provided on Proposal Central, select all applicable research topics, keywords, and relevant areas of CF research for the proposed project. A minimum of one (1) option must be selected per category. C. Outcomes of Past and Current CFF/CFFT Support (Applicants and Sponsors; upload as an attachment) Outcomes of Past and Current CFF/CFFT Support Forms should be completed by the Applicant (Principal Investigator), and the sponsor(s), and uploaded as a single PDF into the application in Section 10. Identify the outcomes of past and current CFF/CFFT support (e.g., subsequent funding from other sources, journal articles, and invited presentations) and the CFF/CFFT grant/award from which they resulted for the past three (3) to five (5) years. Please note that, the following information must be included with each CFF/CFFT research project identified: CFF/CFFT Account # Principal Investigator (P.I.) CFF/CFFT Project Title Role on Project (e.g., P.I., Co-P.I., etc.) Project Start/End Dates Total CFF/CFFT Award Amount Outcomes of Support Individuals who have never received CFF/CFFT support should state that and upload the form. D. Budget Details Personnel Individual salary compensation requested from CFFT may not exceed 20% of the NIH salary cap ($185,100 in 2016) or $37,020 per year for up to three years. In addition, the award will cover standard institutional fringe benefits for that salary. Travel Funds may be requested for award-related travel costs. Awardees are required to attend CRSP face-to-face meetings in Seattle, the annual North American CF Conference (NACFC), and TDN Spring Meeting (see section VII. Budget above for the schedule of required meetings). Indirect Costs Indirect costs are not allowable for the CRSP Awards. CFFT Clinical Research Scholars Program (CRSP) Award, April

8 E. NIH Biographical Sketch and Other Support (Upload as an attachment) The applicant s biographical sketch must be attached. Clearly identify the results of past CFFT support (if any) such as subsequent funding from other sources, journal articles, and invited presentations. List publications and mark in bold those related to CF. You may use an NIH Biosketch. List all other support. The NIH Other Support Form may be used. F. Proof of Citizenship (Upload as an attachment) Clinical Research Scholars Program awards are restricted to individuals who are United States citizens or Permanent Residents. Proof of Citizenship or Permanent Residency must be provided (e.g., copy of passport, birth certificate, or Permanent Resident Visa). A legible, PDF copy of the Applicant/Principal Investigator s Proof of Citizenship or Permanent Residency should be uploaded. G. Letters of Reference/Support (Upload by Sponsors/References) Letters of Support and Reference are weighted heavily during the review. At least five (5) Letters of Support/Reference must be provided on behalf of the Applicant. The letters must be uploaded before the application can be submitted. Invite Sponsors and Referees to Submit Letters through ProposalCENTRAL Please start this process early. Letters of Support/Reference must be submitted electronically by each Sponsor/Referee through ProposalCENTRAL. Go to Section 6. Letters of Support/Reference of the online application, and enter their names and addresses. Automated s (with instructions) will be sent to each Sponsor/Referee through the ProposalCENTRAL website. Letters of Support/Reference must be submitted by the following individuals: 1. Sponsor(s) for this award 2. The Chair of the applicant s department at the Sponsoring Institution Letters from the Sponsor and the Department Chair should clearly describe the Institution s commitment to the professional growth of the applicant. The Chair s letter must affirm a commitment to protect the applicants time for program activities, including travel to meetings required for this award. 3. CF Center Director The CF Center Director at the Sponsoring (or nearby) Institution (if the same person as Sponsor, there is no need to submit duplicates). 4. At least two (2) other individuals familiar with the candidate s scientific interests and abilities Especially with respect to CF-related research and care, including previous preceptors and mentors. The letters of recommendation should attest to the candidate s academic qualifications, motivation, research potential, and commitment to CF-relate research and care. All letters must be uploaded at Proposal Central by each reference, preferably a week before the deadline. These letters must be uploaded prior to submitting the application. H. Names and Address of Sponsors(s)/References (Upload as an attachment) Use the Names & Addresses of 3rd Party Letters Form provided online to list the names, titles, and contact information of the individuals who have been asked to submit Letters of Support/Reference on the applicant s behalf. Upload a PDF copy. I. CF-Related Activities of the Sponsor and Applicant Institution (Upload as an attachment) A template is provided. Describe fully the CF related clinical and research activities of the applicant institution. The Sponsor and the applicant institution should also include a list of their previous trainees CFFT Clinical Research Scholars Program (CRSP) Award, April

9 (past 10 years) and the current affiliations of these trainees. J. Previous Training and Future Plans (Upload as an attachment) A template is provided. Prepare a brief summary of the applicant s previous research and/or clinical fellowship training, including the reasons for entering fields related to CF research and care. In conjunction with the Sponsor, a future training plan should be completed in and should outline the general plan for training the applicant in CF-related research. Participation in supplemental course work and special seminars should be included. Further, this section should clearly indicate plans for introducing the applicant to leading multi-center clinical research trials. Do not exceed two (2) pages. K. Future Career Goals (Upload as an attachment) A template is provided. Prepare a brief summary of the applicant s intended future career goals. This section should specifically describe how this training award will help the candidate meet their career goal of becoming an independent multi-center clinical research investigator. Do not exceed one (1) page. L. Project Proposal (Upload as an attachment) The candidate Project Proposal is limited in length to four (4) pages, not including the Literature Cited. Applications exceeding this page limit will not be reviewed. A Research Plan Template is provided online. At the top of each page, type the PI's name. Each page must be sequentially numbered at the bottom of the page. Key figures and legends must be included in the Project Proposal. Figures and/or legends uploaded as Appendix Material will NOT be accepted. The Project Proposal should include sufficient information to permit effective review. Information should be presented in clearly and concisely. a. Hypothesis and Specific Aims. State concisely and realistically the intent of the proposed research and the hypothesis to be tested. Do not exceed one page. When preparing the specific aims, keep in mind the mission of the Cystic Fibrosis Foundation. b. Background and Significance. Briefly describe the background of the present proposal. Critically evaluate existing knowledge and specifically identify the gaps that the project is intended to fill. Concisely state the importance and rationale of this research by relating the specific aims to longer-term objectives. This section should also show the potential importance of the proposed work to CF. In addition, the applicant should describe the relationship of the proposed work to his/her long-term career goals. Preference will be given to those applicants who have expressed an interest in a long-term career in leading CF multi-center clinical trials. c. Preliminary Results. If applicable, provide a detailed discussion of any preliminary results. d. Experimental Design and Methods. As described in the introduction, the optimal candidate will be one who has an ongoing or upcoming single-center clinical research study or trial that can be directly applied to program objectives. Provide a detailed discussion of the ongoing or proposed clinical research study design, and methods to be used to accomplish the specific aims. Describe the protocols, including methods for new techniques, and explain potential advantages over existing methodologies. If applicable, discuss the data expected to be obtained and the means by which data will be analyzed and interpreted. Provide details of the methods for patient selection and care, as applicable. Discuss potential difficulties and/or limitations of the proposed procedures and alternative approaches to achieve aims. i. As applicable, please specify facets of the project that are clearly defined and those that need further development. Discuss how this award and training would help determine and direct the project components requiring additional resources or advancement, including: study hypothesis; primary and secondary outcome measures; study design; study sample-inclusion and exclusion criteria; sample size estimates; subject enrollment including age range; puberty status; gender distribution; randomization scheme if CFFT Clinical Research Scholars Program (CRSP) Award, April

10 applicable; description of experimental procedures and schedule including a study timeline; drugs and dosage; measures of compliance; follow- up schedule including a time-line; drugs and dosage; measures of compliance; follow-up schedule including a time-line for full project up to three years; ascertainment of response variables: efficacy and safety, training, data collection, data monitoring and quality control; and a description of your proposed data analysis and statistical procedures for your hypothesis testing. e. Literature Cited (not included in the 4 page limit). References should be numbered in the sequence that they appear in the text and listed at the end of the Research Plan. Each citation must include the names of authors, the name of the journal or book, volume number, page number and year of publication (titles are optional). M. Appendices (Upload as attachments) Appendices are restricted to the following three (3) categories: 1. Proposed protocol (if applicable) 2. Up to three (3) reprints of the applicant s work relating to the general area of research in the grant proposal may be uploaded in PDF format. 3. Other materials pertinent to the grant proposal, not already described. Figures and/or legends uploaded as Appendix Material will NOT be accepted. N. Final Steps You may stop at any point, each time remembering to SAVE your entries, and continue/revise until you have actually hit the SUBMIT button. When you log in again to continue, click on the blue tab, Manage Proposals, then the IN PROGRESS tab, and then the Edit button next to your application s title. 1. Validate: Upon completing your application, click on the blue VALIDATE button on the main screen. Attend to any omissions/errors, if prompted, and VALIDATE again. An application will be considered incomplete if it fails to comply with instructions, or if the submitted material is insufficient to permit adequate review. CFFT reviews applications electronically, and only documents submitted online at Proposal Central will be reviewed. Late applications will not be accepted, and the deadline will not be waived. 2. Print face page: After validation, follow the prompts to print the system-generated face page. 3. Submit: Click on the gray button with blue lettering. CFFT will not receive your application until and unless you have submitted it. You will receive an confirmation from proposalcentral (not from CFFT) that your application has been successfully uploaded. This will be your only acknowledgment. If you do not receive it, please contact ProposalCENTRAL immediately to ensure that the application is properly submitted. 4. Sign, scan and the face page to awards@cfft.org by the deadline date. The Applicant (Principal Investigator), the applicant s Sponsor, and the official authorized to sign on behalf of the institution are all required to sign. CFFT Clinical Research Scholars Program (CRSP) Award, April

11 For technical support: Proposal CENTRAL at or on weekdays, 8:00 a.m. to 5:00 p.m. (Eastern) For program/content information: CFFT Grants & Contracts at or Please write, Application Inquiry in the subject line CFFT Clinical Research Scholars Program (CRSP) Award, April