PI Name (Last, First):

Site Name:

CARRA-AF Registry Research Coordinator Pilot Support Program

Project Funding Period: April 1, 2018--March 30, 2019

Application

Application and Selection Process: The site must submit all materials below as a single file using the online applicationby January 18, 2018. Applications will be reviewed and evaluated by the CARRA Registry Operations Committee and an Arthritis Foundation representative. Final selections will be made by the CARRA Registry Operations Committee and applicants will be notified by March 1, 2018. Contact Kelly Mieszkalski ( or 919.668.7531) with questions.

  1. Summary: Provide an overview for the need for coordinator-funding support at your site. Detail how coordinator responsibilities are currently covered at your site and how these funds will result in increased coordinator effort and enable you to a) increase enrollment in the CARRA Registry (include estimates of how many patients you will be able to enroll in the funding period); b) increase the number of bio sample collections; and c) increase enrollment and/or participate in the STOP-JIA, FROST, and new sub studies (page limit: 1 page)
  2. Timeline. Month-to-month description of activities including planned enrollment milestones. If your site is not currently collecting bio samples, participating in STOP-JIA, and/or participating in FROST, provide timeline for when your site will expand to be able to participate in these projects.
  3. Sustainability Plan. Describe how this pilot funding and increased enrollment (and payments resulting from enrollment and follow up) will enable your site to support the coordinator’s salary after the pilot funding period is completed. CARRA is providing a “Coordinator Cost-Calculator” to assist you with projecting the funds to be received at your site based on your enrollment projections.
  4. Budget and justification. All applicants must use template provided (see appendix A).
  5. Site questionnaire (See appendix B)
  6. CARRA Registry Site Delegation of Authority Log. Submit current copy.
  7. PI CV. Include current CV for the site Principal Investigator.
  8. Letter(s) of support. Letter of support is required from the site department chair confirming the coordinator salary amount and a commitment that the funds will solely be utilized to support coordinator effort for CARRA study activities. Consider also including the following: a) a letter of support from an IRB manager stating that your site will be permitted to transition to the SMART IRB (if applicable); b) a letter that expresses support for your site’s coordinator sustainability plan. Additional letters of support are optional but encouraged.

Appendix A

CARRA-AF Research Coordinator Pilot Support Program

Budget and Justification

Project Period: 4/1/18-3/31/19

  1. Budget

A. / Full time coordinator salary / $______
B. / Institutional fringe rate / ___%
C. / Fringe total / $______
D. / Total direct costs for a full time coordinator (A+C) / $______
F. / Amount provided by CARRA/AF Coordinator Pilot
($25K + 8% indirects ($2000)) / $27,000
G. / % effort covered by CARRA/AF Coordinator Pilot (F/D x 100) / ___%
  1. How will the above funds be utilized?

Hire a new coordinator

Pay for coordinator time from institutions’ centralized coordinator program

Other, specify:

  1. Please describe all activities/responsibilities for the individual who will hold this position:

Appendix B

CARRA-AF Research Coordinator Pilot Support Program

Site Questionnaire

  1. Do you currently have a percentage of a dedicated coordinator for the CARRA Registry?
  • Yes: ____ %
  • No
  1. How many of the following pediatric rheumatology providers do you have at your site:

Total # / How many are FTEs?
Pediatric rheumatologists
Nurse practitioners
Fellows
Other pediatric rheumatology providers, specify:
  1. Answer the following questions regarding your site’s clinics. Include off-site/satellite clinics in your reported numbers below.
  2. How many ½ day clinics does your site have in a week?
  3. How many of these ½ day clinics will this coordinator be able to attend?
  1. What is the approximate total number of unique patients seen at your center in the last year?

<250

250-499

500-999

1000-2499

>2500

  1. When did your site get activated for enrollment in the new CARRA Registry?

____/_____ (MM/YYYY)

  1. Tell us your current and projected enrollment in the CARRA Registry and substudies:

# Enrolled as of 12/31/17 (or “N/A”if your site is currently not participating in this substudy or activity) / Assuming receipt of this award, provide your anticipated enrollment for the project year for each category (4/1/18-3/31/19)
Total Registry Enrollment
JIA
SLE
JDM
STOP-JIA
FROST
Biosamples collected
  1. How will the funds help improve biospecimen collection at your site?
  1. Current IRB Type:

Reliant SMART IRB (rely on the Duke IRB for the CARRA Registry)

Local IRB

  • How often does your IRB meet?
  • Who (name and role) currently handles your regulatory submissions?
  • What is the turn-around time from submission to approval?
  • Is your site able to transition to CARRA’s reliant SMART IRB? If yes, a letter of support from an IRB manager stating that your site will be permitted to transition to the SMART IRB is suggested.
  1. List all other studies that will be recruiting patients from your pediatric rheumatology clinic during the funding period (4/1/18-3/31/19):

Study Name and Sponsor / Brief description / Does this study conflict with the Registry as a whole, or any of the substudies? If yes, please explain. / Will the CARRA-AF coordinator also recruit for this study?
  1. Please use this space to provide any additional information about your site and its resources that you feel should be considered by the review committee: