SUCCESS FEE FOR SERVICE PROGRAMS

Transcription

1 SUCCESS GCRC Research CENTER Environment SUCCESS FEE FOR SERVICE PROGRAMS Clare Tyson, MA, CCRA Leila Forney, BSN, RN, CCRP Brigette White MA, CCRP Stephen Skelton, MA

2 SUCCESS CENTER FEE FOR SERIVCE PROGRAMS GCRC Research Environment Research Coordinator (Clare Tyson) Regulatory (Brigette White) Budgets (Stephen Skelton)

3 SUCCESS Research Coordinator Core (RCC) Fee GCRC for Service Research Environment Recruitment Coordination of Protocol Activities Create Source Documentation Maintain Study Documentation Per GCP, ICH RCC Develop SOPs Perform Study Assessments Pre- Implementation Tasks Regulatory Tasks Internal Quality Assurance Monitoring Venipuncture Medication Administration Perform EKG s Specimen Collection IV Infusions Safety Assessments Inpatient Research Visits

4 SUCCESS RCC Rates Research Coordinator hourly rate $40.00

5 Why Use the RCC? RCC can come to you: The RCC coordinators are available to conduct research at your facility The RCC can conduct research at any of MUSC s covered entities (MUHA, UMA, CFC) RCC staff are trained in: Core Clinical Research Training (CCRT) CITI Training Adverse Event Assessment and Reporting Hospital Computer Systems University and Hospital training compliant

6 Why Use the RCC (continued)? Expertise in: Available SCTR services Working with infants to elderly Conducting Clinical Trials Ensuring Regulatory Compliance Availability: After normal business hours if needed Weekends and holidays as needed Provide gap services (i.e. staff on leave, high enrollment times, coverage for unexpected turnover, etc.)

7 Why Use the RCC (continued)? Fee for service structure allows PI s to conduct clinical trials without paying for a full-time medical clinician or study coordinator The RCC service also includes internal quality assurance monitoring (i.e. chart and regulatory review) included in the fee The RCC can provide research nurses for in-patient research procedures. MUSC hospital has designated a bed on 8 West for any inpatient research protocol SUCCESS can assist with this process

8 SUCCESS Center Regulatory Services Success Center Regulatory Services Consultations (Free Service) Development (Fee for Service)

9 SUCCESS Center Consultations Answer questions about federal, state and institutional regulatory requirements Provide feedback on: Document development Regulatory documentation, quality and organization. Provide individualized consultation & training Make available tools & resources Help researchers navigate & understand research regulatory processes

10 SUCCESS Center Regulatory Fee For Service Success Center Services Consultations (Free Service) Development (Fee for Service)

11 SUCCESS Center Regulatory Fee For Service Initial Application(s) $2500 Review project details for regulatory submission requirements Attend required start-up meetings to discuss regulatory processing Prepare sponsor required regulatory paperwork and documents Develop consenting documents and other human subject documentation required for regulatory submission Prepare/submit regulatory applications and documents Communicate with regulatory agencies/sponsors to secure approvals Provide tools for on-going regulatory management by study team

12 SUCCESS Center Regulatory Fee For Service Amendment $900 Review project details for submission requirements Revise documents required for amendment submission Compile amendment change summaries Prepare/submit regulatory amendment/documents Communicate with regulatory agencies/sponsors to secure approval Continuing Review $1000 Compile regulatory information required for renewal Process amendments required in conjunction with renewal application Prepare/submit renewal application Communicate with regulatory agencies to secure approval

13 Why Use Regulatory Fee for Service? Flexibility: Utilize regulatory processing services as needed & for a flat fee Expertise: Regulatory compliance Requirements for application processing Document development Staff have years of experience : Research certified Trained in: Core Clinical Research Training (CCRT) CITI Federal, state and local regulatory requirements

14 Regulatory Fee for Service Summary What it is: Regulatory processing for study milestones Application development Human subject review content development Interactive process Opportunity for regulatory guidance Flat fee service What it is not: Regulatory management for study s lifetime Application responsibility Scientific review content development Autonomous processing Opportunity for regulatory discarding Free service

15 SUCCESS Budget Development Fee for Service Grants Navigators will develop a research study budget and facilitate contract negotiation for industrysponsored studies Prepare an industry contract budget or grant budget in accordance with institutional and funding entity guidelines Meet and communicate with study staff to review protocol, discuss responsibilities, and study requirements Obtain costs for personnel, services, supplies, etc. Assist with study feasibility assessment Prepare final budget and assist with budget/contract negotiation Create a study tracking template to facilitate accurate subject tracking and invoicing Perform periodic post-award communication and consultation

16 SUCCESS Budget Development Fee for Service Service does not include: Medicare coverage analysis and pre-approval epds development Confidentiality Agreement coordination Sponsor contract amendments Every day grants management (purchasing, effort, subject compensation, etc.) Grants Navigators will continue to work with PIs and Business/Grants Managers to support the success of the research study.

17 SUCCESS Budget Development Fee for Service Why use the Budget Development Fee for Service program? New to research Division doesn t have sufficient staff Business/Grants Manager doesn t have enough available time Lack of experience with industry-sponsored clinical trial budgeting and contracting What is the cost? $1,800

18 SUCCESS Budget Development Fee for Service What services are available for free? Consultation and guidance with the preparation of a grant or industry-sponsored budget Access to tools and templates related to budget development and grants management Assistance with the completion of grant applications and required reporting Guidance related to all aspects of grant management

19 Applying for SCTR Fee for Services SCTR Fee for service can be Requested through the SCTR Programs Application & Request Kiosk (SPARK) at

20 Applying for SCTR Fee for Services Information needed to make a request: Study Details Personal Details Services Being Requested

21 Applying for SCTR Research Coordinator Fee for Services

22 Applying for SCTR Fee For Services

23 Applying for SCTR SUCCESS Center Fee for Services

24 Applying for SCTR SUCCESS Center Fee for Services

25 Applying for SCTR SUCCESS Center Fee for Services

26 Billing for SCTR Fee for Services Bills are sent to PI monthly for on going services One time fee for Budget and Regulatory services For more information contact the SUCCESS Center at or We are also available to present to departments upon request