1. Research Education Series “Learn More about the Research Offices” Office of Sponsored Programs –Publications –Poster Presentations Office of Human Research Protection (IRB) Clinical Trials Management Office Legal Affairs

2. Navigating the Grants Process at GHS G H S C l i n i c a l U n i v e r s i t y P a r t n e r s Claire Stam Pre-Award Grant Coordinator Hagan Walker Director Office of Sponsored Programs

3. History and Purpose Office of Sponsored Programs (OSP) – Functions Types of Sponsored Programs Classifications of Sponsored Programs The Proposal Process Award Negotiation Post-Award Administration Contact the OSP Publications and Poster Templates Agenda

4. With its designation as an Academic Health Center and the advent of its Clinical University, GHS is poised to significantly improve patient care through an innovative and ambitious research agenda. –In the past five years, GHS’ sponsored research activity increased from $700,000 in 2010, to over $2.8 million in 2015 in federal funding expenditures alone. –Partnering with Clemson, USC and Furman will guarantee that this activity will continue to grow at an exponential pace. –Success will depend on an appropriate infrastructure to support this caliber of research. The GHS Office of Sponsored Programs (OSP) was established in December 2013 to to ensure accountability in the application for and management of sponsored funding. History and Purpose

5. Functions Office of Record –Serve as central repository for sponsored programs related documents: internal processing forms, proposal, budget revisions, amendments, award notifications/disapprovals, contracts, audit records, invoices, and reports –Maintain record for sponsored programs for internal or external audits Reporting Entity –OSP serves as central clearinghouse for sponsored programs To report accurate statistics on sponsored program activity and funding inventory –Metrics: number/value of proposals; number/value of awards; research expenditures Sponsored Program Compliance –OSP monitors to ensure compliance with sponsor guidelines, GHS policies, and applicable regulations

6. Grant –Agreement that supports a specific project conceived and proposed by the principal investigator –Minimal involvement and control by the sponsor –Grants generally contain a line item budget, detailed scope of work, specific period of performance, commitment to provide deliverables (reports, products), and require fiscal management but have fewer administrative requirements than other funding instruments such as contracts. Cooperative Agreement –A type of federal award that provides assistance to a particular project with substantial federal involvement throughout the life of the project. Contract –Sponsored program contracts are most often awarded on the basis of proposals submitted in response to requests from sponsors. –A contract proposal typically includes commitments to provide the sponsor with data, analysis, devices, or other specified deliverables. –Many contracts provide for substantial sponsor involvement in the performance of the contracted activity. –Contracts tend to be governed by fairly restrictive administrative requirements. Types of Sponsored Programs

7. Research –Sponsored research means all research and development activities that are sponsored by Federal and non-Federal agencies and organizations. –This term includes activities involving the training of individuals in research techniques (commonly called research training) where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. Other Sponsored Activities –Other sponsored activities refers to programs and projects financed by Federal and non-Federal agencies and organizations that involve the performance of work other than instruction and organized research. –Examples of such programs and projects are education training proposals, health service projects and community service programs. However, when the institution without outside support undertakes any of these activities, they may be classified as other institutional activities. Instruction –Instruction means the teaching and training activities of an institution. Except for research training as described above, sponsored instruction and training means specific instructional or training activity established by grant, contract, or cooperative agreement. Classifications of Sponsored Programs

8. The Proposal Process Reach out to Office of Sponsored Programs via: –Phone: (864) 455-9861 –Email: ResearchGrants@GHS.orgResearchGrants@GHS.org –Notification of Intent to Submit Form: http://university.ghs.org/proposal/http://university.ghs.org/proposal/ –Website: http://university.ghs.org/grants/http://university.ghs.org/grants/ Grant Coordinator leads through: –Proposal/budget development –Completing Proposal Processing Form –Connecting with Program Officials –Collaborators/sub-award documentation –Proposal review to ensure adherence to guidelines –Obtaining approval signatures –Submission to sponsor

9. The Proposal Process Submit “Notification of Intent to Submit” form ten (10) business days before sponsor deadline OSP Grant Coordinator will respond within one (1) business day Send guidelines for OSP to review Work with OSP to finalize proposal and budget OSP to complete Proposal Processing Form and Cover Letter Submit all necessary documents to OSP for review five (5) days before submission OSP will obtain approval signatures OSP will submit to sponsor

10. The Proposal Process OSP Services Identify Funding Opportunities Reach out to Sponsors as needed Set timelines Budget Creation and Review Proposal Assembly Review to Ensure Adherence to Guidelines Obtain Approval Signatures Submission Receive Award Notification Contract Negotiation Award Account Set-up Post Award Management and Reporting Assistance

11. Award Negotiation and Acceptance Upon being awarded… OSP negotiates the terms and conditions with the sponsor Submits award agreements to GHS legal affairs for review Prepares document for signature Secures signatures from appropriate persons –GHS’ authorized organizational representative for signing grants is Dr. Spence Taylor. PI’s should never be the only signature on a grant agreement. Remits signed agreement to sponsor Obtains fully executed document and retains official record

12. Grant Account Set up and Administration Once the award agreement is signed…. Your post-award grant coordinator and fiscal manager will: Set up a new grant account for your project Host grant kick off meeting to review the award, reporting requirements, how to spend your grant monies Assists in preparing financial reports and submits reports to sponsor Receive payments from sponsors and deposit check(s) into your account Approves expenses prior to posting to grant accounts Works with project teams to address any issues/concerns Reviews and submits all journal entries to accounting Complete grant closeouts with sponsors and department Facilitates internal and external sponsored programs audits

13. OSP is here to help! Engage with OSP early so we can assist your team throughout the process, including: –Concept development / preliminary planning –Identification of funding opportunities –Research and writing support –Budget and budget narrative development –Letters of support and other supporting documentation –Organizational and legal compliance –SUBMISSION! –Post-award management Contact the OSP

14. Office of Sponsored Programs Employee Services Center 701 Grove Road Email: ResearchGrants@GHS.orgResearchGrants@GHS.org Website: http://university.ghs.org/grants/http://university.ghs.org/grants/ Hagan WalkerClaire Stam DirectorPre-Award Grant Coordinator (864) 455-9861(864) 455-5772 HWalker3@GHS.orgCStam@GHS.org Rebecca TaylorJeanette Saunders Fiscal ManagerPost-Award Grant Coordinator (864) 455-4729(864) 455-4173 RTaylor6@GHS.orgRTaylor6@GHS.org JSaunders2@GHS.orgJSaunders2@GHS.org Contact the OSP

15. Publications and Poster Presentations Publications GHS reports on total number of publications Need to include GHS in citation to promote identification in search Questions or to report publication activity –Cindy Youssef; cyoussef@ghs.orgcyoussef@ghs.org Poster Presentations Standard templates for poster presentations Modified templates for working with affiliated institutions Questions or for templates –Cortney Easterling; ceasterling@ghs.orgceasterling@ghs.org

16. Citing Affiliations: GHS Employees Standard for citing organizational affiliations in publications: Preferred 1) Name, Title*, Division*, Department, Greenville Health System, Greenville, S.C. 2) University appointment*, University* Alternative 1 1) Name, Greenville Health System, Greenville, S.C. 2) University* Alternative 2 1) Name, Greenville Health System, Greenville, S.C. *Optional information

17. Poster Template Example

18. Templates with Academic Partners

19. Greenville Health System Office of Human Research Protection (GHS OHRP) Institutional Review Board

20. GHS has 3 IRB Committees: Committee-A reviews all research with the exception of oncology & pediatrics Committee-B reviews all pediatrics and other research, as needed, with the exception of adult oncology Committee-C reviews all adult oncology research

21. IRB Responsibilities Protection of human subjects in research Ensure compliance with research regulations

22. E IRB https://eirb.healthsciencessc.org

23. IRB Review Process IRB Coordinator pre-screening of new consent forms IRB Coordinator screening of eIRB submission prior to assigning for IRB review Submitting an application which has been thoroughly and thoughtfully completed is important IRB Committee review

24. Principal Investigator Responsibilities

25. Conflict of Interest

26. CITI Research Education www.citiprogram.org

27. Helpful Information http://university.ghs.org/research-protection/ http://university.ghs.org/research-protection/ OHRP Policies & Procedures Manual eIRB Submission Instructions & Deadlines Consent Form Templates Other templates that may be required for submission (i.e., eIRB Agreement of Investigators Signature Page, Scientific Review Form, etc.)

28. Contact Information Christopher Wright, MD Medical Director 455-8997 cwright2@ghs.org IRB Coordinators Committee-A: Kelly Stephens / 455-4984 / kstephens@ghs.orgkstephens@ghs.org Committee-B: Glyn Hamilton / 455-4360 / ghamilton@ghs.orgghamilton@ghs.org Committee-C: Sharon Davis / 455-6607 / sdavis4@ghs.orgsdavis4@ghs.org

29. Questions?

30. CLINICAL TRIALS MANAGEMENT OFFICE (CTMO)

31. Background Per the Association of Academic Health Centers, academic health centers continue to assess, change, and improve clinical research administration to advance science and better serve patients nationwide. In recent years, clinical trials offices (CTOs) and clinical trials management offices (CTMOs) have emerged within the academic health center research infrastructure to streamline and enhance institutional research capabilities.

32. Background Health center leaders are proactively developing and organizing research administration infrastructure to support clinical research and related compliance activities. Reference Article - Clinical Trials Offices: What’s New In Research Administration? Elaine Rubin, PhD, and Danielle Lazar, MA

33. Greenville Health System GHS Clinical Trials Management Office (CTMO) - History –Established in 2014 to serve as a centralized resource for GHS researchers, staff and departments involved in clinical trials research and for sponsors seeking to conduct clinical trials at GHS –Established to provide comprehensive support for clinical trials research

34. Greenville Health System GHS Clinical Trials Management Office (CTMO) - History –Established to create a standardized process to conduct clinical trials research throughout the institution –Established to create infrastructure, policies and procedures to support clinical trials research throughout the institution

35. Greenville Health System GHS Clinical Trials Management Office (CTMO)- Mission –To enhance the quality of clinical trials research –To facility the development, implementation and management of clinical trials research –To ensure that clinical trials are conducted in accordance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Institutional Review Board (IRB) policies and Food and Drug Administration (FDA) regulations, HHS and OHRP regulations

36. Greenville Health System GHS Clinical Trials Management Office (CTMO)- Services –Develop and provide education on the requirements and procedures related to the conduct of clinical trials research –Assist the GHS researchers, staff and departments with clinical trials research project feasibility, development, resourcing and execution

37. Greenville Health System GHS Clinical Trials Management Office (CTMO)- Services –Provide assistance and consultation with budget development and preparation and contract negotiations –Serve as an expert resource for information on the issues and requirements for the conduct of clinical trials research –Serve as the point of contact for questions or issues related to clinical trials research

38. Greenville Health System GHS Clinical Trials Management Office (CTMO)- Services –Interact and communicate with sponsors, CROs and other entities on behalf of the institution, researcher and departments on issues related to clinical trials research –Provide oversight and assistance with registration of clinical trials research information and posting of results –Monitor overall accrual of participants in clinical trials

39. Greenville Health System GHS Clinical Trials Management Office (CTMO)- Services –Develop and implement programs and initiatives to enhance the quality of clinical trials research –Provide education and training for all staff involved in clinical trials research –Support regulatory compliance –Support clinical trials research billing compliance

40. Greenville Health System GHS Clinical Trials Management Office (CTMO)- Projects –Current Projects: Developing Policies for Clinical Research Billing, PI Payments, Overhead Costs and Residual Funds Developing Standard Operating Procedures to streamline procedures for conducting clinical trials research throughout the institution Assisting with clinical trials research component within EPIC –Future Projects: Education of staff on CTMO policies and SOPs

41. CTMO Contacts Jeannie Cunningham 455-4175 (O) 449-7913 (C) Fanny Guillerminet, PhD 455-8594

42. Legal Affairs

43. Cindy Cambron Deputy General Counsel General Focus: Patient Care/Hospital Operations, Consent/End of Life, Medical Staff/Credentialing/Physician Services, IRB Advises the IRB Attends IRB meetings in an advisory capacity Reviews documents, including Informed Consent Forms, when requested

44. Anne Ellefson Deputy General Counsel of Academics and Community Affairs General Focus: Academic Matters, Intellectual Property, Grants, Research (Clinical University), Residents, Technology Transfer Contract Review Works with Research Development Corporation related issues Works with outside counsel on Intellectual Property Issues

45. Madison McKissick Staff Attorney General Focus: Contract Matters Clinical trial agreements and confidentiality agreements/NDA’s review and negotiation Review and drafting of other research/data related agreements i.e. investigator initiated trials, DUA’s, BAA’s

46. Resources Legal Affairs Website (find us through Plexus) Template documents and direction (BAA’s, CDA’s, DUA’s, etc.) Contract review and drafting Legal questions related to research PaperTracer

47. Thank you! Find more information & provide your feedback: http://university.ghs.org/research/events/ Next session: Research Development Corporation (RDC) will present: Overview of RDC & Intellectual Property Thursday, March 17 th !