Office of Sponsored Programs Lunch and Learn Training Series “OSP 102” UAB Extramural Checklist

1. Office of Sponsored ProgramsLunch and Learn Training Series“OSP 102”UAB Extramural Checklist Thursday, December 5, 2013 Margaret Cameron Spain Auditorium

2. OSP 102OSP Extramural Checklist Learning Objectives • What is the UAB Extramural Checklist? • Why is the UAB Extramural Checklist required by OSP? • When is the UAB Extramural Checklist required to be submitted to OSP? • Where can I find the UAB Extramural Checklist? • UAB Extramural Checklist – Detailed Overview • Questions

3. What is the OSP Extramural Checklist? • The UAB Extramural Checklist is the official proposal submission document for extramurally funded research submissions at UAB. • The UAB Extramural Checklist provides formal documentation fromthe PI and Administrative Department Chairperson’s (Dean)authorization to submit the proposal to the sponsor. • The UAB Extramural Checklist provides OSP with critical, specific information for internal review, documentation and approval.

4. Why is the OSP Extramural Checklist Required? • Provides Research Administration detailed information regarding proposals/proposed award agreements needed to conduct a proper review. • Provides Research Departments information concerning obligations of departmental resources to conduct the project. • Captures PI wet signature attesting to project commitments. • Captures signature of Department Chair, Dean and Facility Planning if needed.

5. Why is the OSP Extramural Checklist Required? • Per the SF 424 application guide and NIH Grants Policy Statement, UAB is responsible for; • verifying the applicant organization’s eligibility, and the accuracy, validity, and conformity with the most current institutional guidelines of all the administrative, fiscal, and scientific information in the application, including the Facilities and Administrative rate. • The signer further certifies that the applicant organization will be accountable both for the appropriate use of any funds awarded, and for the performance of the grant-supported project or activities resulting from this application. The grantee institution may be liable for the reimbursement of funds associated with any inappropriate or fraudulent conduct of the project activity.

6. When is the OSP Extramural Checklist Required? • The UAB Extramural Checklist is required for any new or subsequent submission that requests new or supplemental funding. • The UAB Extramural Checklist is required for a change in PI for a existing project.

7. Where can I find the UAB Extramural Checklist? Office of Sponsored Programs Website • OSP Extramural Checklist • The UAB Extramural Support Checklist Instructions and Glossary

8. The UAB Extramural ChecklistDetailed Overview

10. Reference links are included in the introductory paragraph for checklist instructions and glossary and required documents for each submission type. The Checklist begins with a reminder to submit all draft proposals 7 business days prior to the sponsor’s deadline, and all final proposals 3 business days prior to the sponsor’s deadline.

11. In the heading, check the box if this is an electronic submission 1. The last name, first name, middle initial and Blazer ID of the Investigator. Policy No. OSP.RES.200 - Definition of a Principal Investigatordefines who may serve as a PI. The UAB School, Department and Division to be associated with this project. In most cases this is usually the same as the primary appointment. Centers are not valid entries.Enter the trainee or assignee name and Blazer ID if this is a fellowship or VA-IPA submission. 2. Enter the sponsor from whom UAB will directly receive funding. If a clinical research organization (CRO) is involved, indicate the CRO in number 25, not here.

12. 3. Check the correct proposal type being submitted for review. Please check only one proposal type. If the proposal type is a “Change of PI”, please include the current OSP Assigned Number and the previous PI for the project. If the proposal type is a “Resubmission”, please include the previous OSP Assigned Number for the original submission. Reminder: An RPL (Responsible Personnel List) is a required document for the 5 submission types with a double asterisk **.

13. OSP Submission Types

14. OSP Submission Types

15. 4. Enter the sponsor deadline date (if applicable). If there is no sponsor deadline date, please include anticipated start date. 5. Check the appropriate box(es) for all performance sites to be used. 6. On Campus / Off Campus - Refers to the location of research activities. Off-Campus refers to activities performed in facilities not owned or leased by UAB. If more than 50% of a project is performed Off-Campus (excluding the subcontract component), the Off-Campus rate will apply to the entire project 7. Select the type of cost sharing (if applicable). See the Cost Sharing Commitment Formor In Kind Cost Sharing Formfor definitions. Cost sharing definitions are on page 2 of the Cost Sharing Commitment Form.

16. 8. Enter the full title of the project (complete, no abbreviations). For Industry clinical trial agreements, this should match the protocol title. 9. If this is a Competing Continuation, enter the original proposal number and original project start date. 10. Contact Person(s): Enter the full name and Blazer ID of the person to be contacted if a question arises about this application. Enter secondary contact information, i.e. study coordinator (FAP), if applicable. Award Manager: Enter the full name and Blazer ID of the person managing the funds. 11. Indicate if this project involves any renovation - Yes (Y) or No (N). If Yes, Facilities Planning (4-1219) must sign off on this checklist. NOTE: If the primary purpose of the project is construction, e.g. federal or non-federal funding to supportconstruction of a building or major renovation, please use the Construction Checklist. Construction grants and contracts should be coded as “Other Sponsored Activities”.

17. 13. Select the CCTS Research Type or Not Applicable. • Clinical Research • Patient-oriented research (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects or human materials. • Translational Research • The process of applying insights and discoveries generated during laboratory research and in preclinical studies, to the diagnosis, treatment or prevention of human disease. This includes T1 research (moving basic discoveries into candidate health applications), T2 research (assessing value of T1 application for health practice leading to evidence-based guidelines), T3 research (moving evidence-based guidelines into health practice through delivery, dissemination and diffusion research), and T4 research (evaluating real world health outcomes of a T1 application in practice). • 14. The UAB unit (Department and Division) that is responsible for monitoring and managing the award funds and their organization code. The organization code is required. • 15. Billing/Collection Responsibility Designation: Select the appropriate responsible group. • PI/Award Manager for Clinical Trials and Milestone-based Contracts • Grants & Contracts Accounting for Letter of Credit (LOC) Federal, Federal Pass-thru and reimbursement and scheduled payment projects.

18. 16. Keywords: List a minimum of 3 scientific keywords that best describe your research or project. Do not list Principal Investigator’s name or the Sponsor’s name. 17. Will funds be leaving UAB? Indicate Yes (Y) or No (N). If yes, check subcontract or consultant, or both if applicable. Please include the Statement of Intentor Letter of Collaboration (if applicable) or a letter of support for the consultant. 18. Announcement ID No. - The Announcement or Solicitation number, PA, RFA, RFP, etc. in response to which a proposal is being submitted. 19. Enter the URL address of the program name to which this proposal relates, e.g. Unsolicited R01 (if applicable).

19. Sponsored Research • Definition: Sponsored Researchis all research and development activities that are sponsored by Federal and Non-Federal agencies and organizations. Phase I or Phase I/II Clinical Trials are Sponsored Research. All UAB Investigator Initiated Clinical Trials are Sponsored Research. Fellowship/Training awards to perform research activities are also considered Sponsored Research. • Clinical Trials are used to determine whether new drugs, devices or treatments are both safe and effective. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. • Examples of Sponsored Research awards are the development of a new: • Drug • Product • Technology • Exploring a hypothesis • Conducting animal models • Phase I, Combined Phase I & Phase II, and Investigator Initiated Clinical Trials • Fellowship/Training awards given for research purposes – Federal and Non-federal • Special purpose equipment – equipment which is used only for research, medical, scientific, or other technical activities. • Included in this category are NIH funding mechanisms starting with the following letter: • F-seriesT-series D-series K-series N-series P-series S-series • R-series (with the exception of conference grants R13 & R25) • U-series (with the exception of conference grants U13)

20. Sponsored Instruction The Sponsored Instructioncategory applies when the award’s primary objective is to teach and or train, whether the teaching and or training is offered for a credit toward a degree or certificate or on a non-credit basis. Such teaching and or training can be offered through regular academic departments or separate divisions. Included in this category are federal grants starting with the following letter or number: R25 (education projects)

21. Other Sponsored Activities • Programs and projects financed by Federal and Non- Federal agencies and organizations which involve the performance of work other than instruction and sponsored research, Phase II (stand alone), III and IV Clinical trials. • Clinical Trials are used to determine whether new drugs, devices or treatments are both safe and effective. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. • Examples of Other Sponsored Activities are: • • Clinical Trials – Phase II (stand alone), III and IV • • Health service projects and community services programs • • Conference Grants (e.g. NIH R13 and U13) • • Theater performances • • General purpose equipment - equipment which is not limited to research, medical, scientific, or other technical activities. • • Construction contracts and grants • • Verifying and or testing a product that has already been created • • Any awards that are not Sponsored Research or Sponsored Instruction • Included in this category are federal grants starting with the following letter or number: H-series (excluding HHSN which is sponsored research) • R13 (conference grant) and U13 (conference grant)

22. 21. Instrument Type: Check either Contract or Grant A grant is a funding mechanism for a broad programmatic objective with standard and acceptable terms and conditions which are preset by the awarding entity and are non-negotiable by UAB. A contract is a funding mechanism for specific deliverables in which all or some of the more rigorous terms and conditions are subject to review and acceptance by signature by UAB, and if those terms and conditions are not acceptable would require negotiation between the parties. Contracts, like those provided by the federal government or industry sponsors, are subject to negotiated terms and conditions.

23. 22. Activity Description - If you selected Grant in # 21, see the grant table on slide 23 and 24. If you selected Contract in #21, see the contract table on slide 25 and 26:

29. 23. CFDA # (If applicable) – Catalog of Federal Domestic Assistance #- Only applies to federal grants. Not applicable to federal contracts or industry agreements. 24. If Clinical Trial was selected in # 22, complete the information below: • Enter the CRO name (if applicable). • Select the appropriate source of the protocol and provided the protocol # and IND or IDE #. • Indicate if the CCTS (Center for Clinical and Translational Science) will be utilized. • Indicate if FAP has reviewed the project. • If registered on CT.gov provide the NCT number. • Provide the Sponsor/CRO Contact Name, telephone number and email address, and sponsor's reference # for the contract if applicable. 25. Enter the Sponsor/CRO contact name, telephone #, email address and reference #.

30. 26. ProjectRequestedDates 27. EntertheDirectandF&A(IndirectCost)toshowtotalfundsanticipated.For Non-competingapplications Indicatethefundsbeingrequestedforthecurrentbudgetperiodonly.Rememberthedollaramountshould reflectthenewamount/increaseandnotincludepreviouslyawardedamounts.EntertheF&A(Indirect Cost)Rate.(Selecttheapplicablemethodologyin accordancewiththeIDCRateAgreement) SelecttheF&ARateBasis-TDC,MTDCorClinical TDC(TotalDirectCost)–F&Acalculationmethodologywithnoexclusions. MTDC(ModifiedTotalDirectCost)–F&A(IDC)Calculationmethodologyin accordancewithDHHSColleges andUniversitiesRateAgreementthatexcludesany Subgrant/Subcontract in excess of $25,000, Capital Expenditures, Equipment> $5,000,PatientCare Costs,Rental Cost of Off Site Facilities,Student Tuition Remission, Scholarships and Fellowships Clinical–F&Acalculationforclinicaltrialswhichmeettherequirementsforflat26% appliedto allexpenses:UAB Clinical Trial Rate Policy UABF&A(IndirectCost)ReimbursementPolicy: 28.IndicateifanyF&A(indirectcosts)areto besharedwithadepartmentotherthanthe PI‘s primaryappointment? Yes(Y)orNo(N).Ifyes,completeandattachtheIndirectCostRevenueRedistributionAgreement: http://www.uab.edu/uabra/ogca/ogcapdf/idcrra.pdf

31. 29. If this is related to any other agreements, please provide the related link/proposal number, as applicable. PMA (Project Master Agreement) CDA (Confidentiality Agreement), MTA (Material Transfer Agreement), or Non Sponsor Funded Research Project 30. Review the Export Control guidelines and decision tree and answer the related question - Yes or No.

32. 31. Existing Intellectual and/or Tangible Property A full and accurate understanding of the intention to use existing intellectual property (i.e conceived and/or reduced to practice) or tangible property (cell lines, etc) in the proposed study is essential. Identification of property to be used and ownership rights in such property allows UAB/UABRF’s rights in UAB’s existing property to be protected, ensures that UAB uses property owned by third parties in a manner consistent with existing contractual rights and obligations or identifies circumstances where requests for approval for additional rights and uses should be made and assists UAB in negotiating contractual terms that are realistic, appropriate to the facts and circumstances of the proposed study and maintain an acceptable risk tolerance.

33. 32. Intellectual Property Declaration for Industry Sponsored Clinical Studies Industry sponsored clinical studies are primarily testing arenas designed by and for the benefit of the sponsor. Accordingly, opportunities for UAB researchers to conceive and/or reduce to practice new or serendipitous inventions are likely to be rare. Furthermore, if such inventions relate to the sponsor’s product, the sponsor is likely to require assignment of ownership rights and consequently subsequent commercialization revenue, if any. You need to inform UAB if you are willing to proceed with a study on that basis or not. Mark an X in either 1 or 2 and initial next to your entry.

36. Extramural Checklist Required Signatures Principal Investigator/Project Director - PI certifications are required, no “per” signature is allowed. Division Director - only if required by the department Facility and Planning Signature – required if project involves any renovation. Department Chair - required Dean - required if the project has cost sharing, establishes a new faculty position, requests additional space, or is being transferred in or out of UAB.

39. Questions?

40. Next OSP Lunch and Learn January 6, 2014 Margaret Cameron Spain Auditorium 12pm to 1pm