SCHOOL OF MEDICINE OFFICE OF RESEARCH ADMINISTRATION

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1 SCHOOL OF MEDICINE OFFICE OF RESEARCH ADMINISTRATION Step By Step Guide for: Coeus Proposal Development (Coeus PD) (in place of eis) for Paper (Hard) Copy and Electronic (non Grants.gov) submission Effective March 15, 2010 Preparing a paper (hard) copy proposal for submission to a sponsor. Preparing an electronic proposal for submission to a sponsor other than Grants.gov. If you are submitting a proposal to a sponsor who requires submission through Grants.gov you are NOT required to complete a Coeus Proposal Development (Coeus PD). Input into Coeus Premium or CoeusLite information previously completed on the Electronic Information Sheet (eis). Begin to complete the Proposal Development Module by clicking on > Maintain> select > Proposal Development >.

2 To create a New Coeus eis click on Maintain > Proposal Development Search Window This screen allows you to create a new proposal, or search for an existing proposal. If you are creating a new COEUS PD select < Cancel >. Select < Edit > New Proposal, or use the < Add > icon. If you are searching for an existing proposal, enter the proposal number the Proposal Number column.

3 Search for an existing proposal Enter proposal number Select Find or Hit > Cancel > Create a new proposal > Edit > New Proposal or > Add Icon

4 PROPOSAL TAB (ENTER ALL OF THE FOLLOWING INFORMATION): Title Start Date (Required). (Enter the date the proposal is expected to start in mm/dd/yy format) End Date (Required). (Enter the date the proposal is expected to end in mm/dd/yy format) Proposal Type (Select from the Drop Down Menu) Activity Type (Select from the Drop Down Menu) Anticipated Award Type (Select from the Drop Down Menu) Sponsor Prime Sponsor (If applicable (if subcontract is selected as the Anticipated Award Type) Sponsor Proposal No (if applicable) (If Proposal Type is (Revision, Continuation,,,,,) Original Proposal (If applicable) (If Coeus was used to create a prior version of this proposal)

5 TITLE Enter the title of this proposal. START/END DATE Start Date (Required). Enter the date the project is anticipated to start in mm/dd/yy format. End Date (Required). Enter the date the project is anticipated to end in mm/dd/yy format.

6 PROPOSAL TYPE (SELECT FROM THE DROP DOWN MENU) Continuation Internal Application Negotiation Only New No Cost Extension Pre Application Renewal Resubmission Revision Task Order Select Proposal Type for this proposal

7 CONTINUATION A progress report that must be submitted to receive an increment of funding from a previously awarded amount. This proposal type allows departments to workflow business documents and addresses research compliance areas. This proposal type WILL NOT create an Institute Proposal Record and will be excluded from Institutional Success Rate calculations. INTERNAL APPLICATION A proposal for funding by JHU (e.g., SOM Clinical Scientist Award) or a proposal for Interdivisional coordinated programs requiring JHU internal peer review (e.g., NIEHS Superfund Basic Research and Training Program). Proposals of this type WILL NOT create an Institution Proposal Record and will be excluded from Institutional Success Rate calculations. NEGOTIATION ONLY This proposal type allows department end users to workflow necessary business documents and addresses research compliance areas (protocol, COI, etc.) for proposals that do not include dollar amounts (MTA agreements, Non Disclosure agreements, Confidentiality agreements, Memorandum of Understanding, Letter of Intent, etc). Once the Institute Proposal number is created, the Research Administration Office can use the Coeus negotiation module to track negotiation activities related to the agreement. Institute Proposal records with this type will be excluded from Institutional Success Rate calculations. NEW A new proposal being submitted to a sponsor. NO COST EXTENSION This proposal type

8 PRE APPLICATION An application that applies only to preliminary proposals that require submission through Research Administration. Some program solicitations require or request submission of a preliminary proposal in advance of submission of a full proposal (i.e. NIH, NSF, etc). NOTE: Only pre applications that require ORA review and approval should be submitted to ORA. RENEWAL Proposal that requests an additional award that will continue funding a previously awarded study and has either an announced open competition for the existing award or is not open to competition, but also is not guaranteed to be funded. Proposals of this type will receive a new SAP Grant Record created. RESUBMISSION Revision of a previously submitted and possibly still PENDING proposal. Think 2 nd or 3 rd attempt at getting a project funded. These 2 nd or 3 rd attempts should ALWAYS create a new Institute Proposal number. This proposal type should be used to process Administrative Revisions, where the sponsor requests a change in proposed scope/budget. REVISION Proposal that requests additional funding, equipment, time, etc. for an existing award and project period. Previously known as a Supplement (Non Competitive or Competitive). TASK ORDER

9 A proposal requesting funds for work or services to be conducted under an existing Master Agreement (a Master Agreement is a type of contract for services that does not procure or specify a firm quantity of services except through the issuance of Individual Task Orders.

10 ACTIVITY TYPE (SELECT FROM THE DROP DOWN MENU) Organized Research Instruction Other Sponsored Activity Clinical Research All research that involves patients or PHI, or clinical testing or procedures, or drug/device diagnostic testing in humans or any planning/lab/clinical service in support of such clinical research." ORGANIZED RESEARCH Research activities include rigorous inquiry, experimentation or investigation to increase scholarly understanding in the involved discipline. Examples include awards to support research activities; to maintain facilities, equipment and/or operation of a facility to be used for research; for the writing of books, when the purpose is to publish research results; for data collection, evaluation, analysis and/or reporting. Clinical trials sponsored by federal or foundation grants or cooperative agreements (not commercial organizations) are considered organized research. Selecting this Activity Type will route proposal to

11 GA s/directors in ORA. DHHS Agreement F&A for Organized Research On Campus: 64% Off Campus: 26% Commercial On Campus: 72% Off Campus: 34% INSTRUCTION Instruction activities include any project where the purpose is to instruct any student at any location. Recipients of instruction may be JHU students or staff, teachers or students in elementary or secondary schools, or the general public. Examples include: Curriculum development projects, including projects which involve evaluation of curriculum or teaching methods. Note that such evaluation may be considered Research when the preponderance of activity is data collection, evaluation and reporting. Projects involving JHU students in community service activities for which they are receiving academic credit; activities funded by awards to departments or schools for the support of students; fellowship support for pre doctoral and post doctoral training activities, including grants funding dissertation work and related travel; Support for writing textbooks or reference books, or creating video or software to be used as instructional materials. Examples: NIH K, F, and T applications, Foundation fellowships. DHHS Agreement F&A for Instruction On Campus: 8% Off Campus: 8% OTHER SPONSORED ACTIVITY Other sponsored activities include programs involving work other than Instruction and Organized Research. Most projects in this category do not directly involve students and gain little benefit from libraries, therefore the F&A rate application to this category is less than for Research or Instruction. Examples of Other Sponsored Activities include: Travel grants, Support for conferences, seminars or workshops; Support for University public events such as lively art ; Publications by JHU Press; Support for student participation in community service projects which do not result in academic credit; Support for projects pertaining to library collections, acquisitions, bibliographies, or cataloging; Programs to enhance institutional

12 resources, including computer enhancements, etc; Health service projects. DHHS Agreement F&A for Other Sponsored Activities On Campus: 32.2% Off Campus: 18.8% CLINICAL RESEARCH Clinical Research is defined as All research that involves patient or PHI, or clinical testing or procedures, or drug/device diagnostic testing in humans or any planning/lab/clinical service in support of such clinical research. Selecting this Activity Type will route this proposal to the ORA Fells Point Clinical Trials Office, if the sponsor or prime sponsor are commercial or foreign commercial. F&A Rate for Commercial Clinical Research On Campus: 72% Off Campus: 34%

13 AWARD TYPE (SELECT FROM THE DROP DOWN MENU) Select the Award Type from the drop down menu. The Award Type is fed by SAP (how the account will be set up in SAP). Grant Contract Cooperative Agreement Clinical Trial Fixed Fee Subgrant Subcontract Select Anticipated Award Type for this proposal

14 GRANT Grants are usually awarded to support or assist projects, whereas contracts procure a definite service or product. Grants are less restrictive than contracts, although technical and financial reports are generally required. Grants may be awarded by foundations, corporations or agencies of federal government. Amounts and types of awards vary from sponsor to sponsor, and many agencies offer several sorts of grant opportunities. Examples: NIH R, P mechanisms, AHA, ACS, etc. CONTRACT Contracts are legal agreements used for procuring a specific service or product. When another organization subcontracts to JHU, it is also a contract, but it is classified as a subcontract for record keeping purposes. In the case of a fixed price contract, a set lump sum payment is established in advance for performance of a specific set of tasks or delivery of a certain service (e.g., $/lab test per completed patient) and payment is limited to such price multiplied by the number of units performed. Cost reimbursement contracts provide for payment of actual costs incurred, up to a ceiling amount equal to the total estimated cost stated in the contract. The contract may discontinue work on the project after costs reach this upper limit, unless the sponsor increases the total contract. However, the reporting and record keeping necessary to document the expenses on a costreimbursement contract usually outweigh the advance of working with a more flexible cost ceiling. COOPERATIVE AGREEMENT The form of federal assistance involves both the Government and the Grantee sharing responsibility for programmatic management of the project. Cooperative agreements anticipate substantial federal involvement with the recipient during performance of the contemplated activity. Specific terms of collaboration are spelled out in individual agreements, which ORA will review carefully with the investigator. In all other respects, cooperative agreements follow the policies applicable to grants. Example: NIH U Mechanism.

15 CLINICAL TRIAL Should only be used for a clinical trials awarded from commercial organizations. Do not confuse this with the Activity Type of Clinical Research. A biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Clinical trials of an experimental drug, treatment, device, or intervention may proceed through four phases: Phase I. Testing in a small group of people (e.g., 20 80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects) of a drug. Phase II. Study in a larger group of people (several hundred) to determine efficacy and further evaluate safety. Phase III. Study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use. Phase IV. Studies done after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use. FIXED FEE A Fixed Cost or Fee for Service Contract is one in which one party pays the other party, a predetermined price, regardless of actual costs, for services rendered. SUBGRANT Collaborative arrangements in support of a research project in which part of an activity is carried out through a formal agreement between a grantee and one or more other organizations. Example: University of Virginia, Principal Investigator has been awarded an NIH R01 grant and wants JHU PI to collaborate on the project. Since the Prime award is a grant, this would be a subgrant.

16 SUBCONTRACT An award under a prime contract. Same basis as the Subgrant, but the Prime Sponsor s Award is a contract.

17 SPONSOR The sponsor is the organization providing funds directly to JHU. If your proposal will be a subcontract to another organization s submission of a proposal, enter the submitting organization as the Sponsor. Use search icon (magnifying glass) Under < Acronym column > Add acronym (i.e., NIH*) Hit < Search > for Sponsor Sponsor is located, highlight sponsor PRIME SPONSOR If your proposal will be a subgrant subcontract to another organization s proposal submission, enter the agency/sponsor providing the funds to that organization. If your institutional proposal is not a subgrant or subcontract, leave this field blank. SPONSOR PROPOSAL NO Enter the assigned proposal number from the sponsor (if applicable). Identification number assigned by a Sponsor to the proposal after submitting it to them. Required if the proposal type is: Renewal, Resubmission, Revision, or Continuation. Example: R ORIGINAL PROPOSAL Required if the proposal type is Renewal, Resubmission, Revision, No Cost Extension, Continuation NCE or Task Order. Use magnifying glass icon to search for the original proposal number.

18 ORGANIZATION TAB This contains the contact for Johns Hopkins and performing sites involved in the project. The Organization and Performing Organization fields default to the institutional data for the proposal unit. To add an additional location will work will be performed (i.e., Ross 720), click the <Add> button (located in the upper right of the screen). A new Organization/Location field will be created beneath the default Organization data. Select the Type from the drop down list: select < Performance Site >. Type the performance site in the blank Location Field. MAILING INFO TAB Complete: Deadline, Mail By, and Type blocks. MAILING INFO TAB Complete: Deadline, Mail By, Type blocks. Deadline This is the date the proposal must be received by the sponsor. Enter the due date in mm/dd/yyyy format. Select the appropriate option button, indicating if this is the date by which the proposal must be postmarked or received by the sponsor. Mail By This is who will send the proposal to the sponsor. If electronic, select ORA; if paper/hard copy, select Department. Type Is the proposal electronic or paper/hard copy. If electronic, select OSP; if paper/hard copy, select Department.

19 List all JHU faculty under the investigator tab. Use the < Find Person> tab.

20 Cer Select PI and Lead Unit (NOTE: Lead Unit is where the proposal, if awarded, will be set up in SAP). Certify all investigators. Investigator Tab INVESTIGATOR TAB Enter ALL JHU faculty contributing measurable effort under the investigator tab. Click < Find Person > Person search window opens. Enter last name of investigator in Last Name field. Select by highlighting the investigators name. Click <OK>. Window closes and you return to the investigator tab. The investigator will be added to the list. Indicating the Lead Unit The lead unit is indicated only for the PI. This is the unit in which the proposal is created and the project will be managed.

21 Put the percent effort the investigator will put forth on this proposal. o NOTE: If there is a difference between efforting put forth and effort for salary requested, answer the cost sharing question under Questionnaire and provide an I/O for the cost sharing. CERTIFY INVESTIGATORS Highlight faculty name Hit < Certify > button Certify all investigators CERTIFICATION OF PI: NEED TO OBTAIN PI SIGNATURE ON CERTIFICATION QUESTIONS Print out certification questions for Principal Investigator of this proposal File > Print > Certification Obtain PI signature Upload signed PI certification Main menu < Edit > < Narrative > select <Other> titled: PI signed certification

22 SPECIAL REVIEWS TAB Select from the following special reviews that pertain to this project. Animal Usage Biohazard Materials Foundation Relations Hazardous Chemicals Human Subjects International Program Radioactive Isotopes Recombinant DNA Space Change Stem Cell TLO Review (Potential Conflict) Special Review Approvals Approved Institutional review complete Exempt Institution review approved as exempt Indefinite Plans Not submitted Not yet applied Pending no institutional status Submitted Unknown Enter the following information based on Activity Type Approval Date Protocol Number Application Date Approval Date NOTE: For NIH Grants.Gov proposals, if application type is New, approval date should be marked as Pending.

23 Special Review Tab

24 Special Review Tab

25 SCIENCE CODE TAB If this project involves any of the following, select appropriate Science Code. 1. AIDS/HIV 2. Cancer 3. Vaccine 4. Women s Health 5. Internal Proposal 6. Hopkins 7. Maryland 8. Baltimore 9. Career Award 10. International Programs 11. Foundation Relations 12. HIPAA 13. Confidentiality Agreement 14. ARRA (American Recovery and Reinvestment Act) Type an asterisk * under the Code column Hit the < Find > button Select appropriate code from the list of codes that are required for this proposal.

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27 Highlight the appropriate science code and select <Ok>

28 RESEARCH COMPLIANCE QUESTIONS Answer all Research Compliance Questions. Main Menu < Edit > Questionnaire

29 YES/NO QUESTIONS Answer all yes/no Questions Main Menu < Edit > Yes/No Questions o Other question sets may appear under this section based on the information the preparer provides in the proposal. NOTE: If Cost Sharing is required on/for this proposal, YOU MUST answer the Cost Sharing question Yes. Under the comment section, provide percent of effort that is being cost shared and the I/O.

30 NARRATIVE TYPE For paper (hard) copy and non Grants.gov proposal submissions, enter the following narratives under < Other >. Title each upload as stated below (Items 1 6). Narrative Uploads (upload all that are applicable to this proposal submission). Some acceptable types of uploads for paper (hard) copy and non Grants.gov submissions. Include: 1. Internal Budget 2. Sponsor Guidelines 3. Proposal 4. Sponsor Signature 5. PI Certification 6. Clinical Research Supplemental Info Sheet All type of file extensions may be used (i.e., docx, pdf, etc). 1. Internal Budget o Main Menu < Edit > < Narrative > select < Other > from drop down list. o Title this < Other > narrative as INTERNAL BUDGET. o If you are not using Coeus to develop your proposal budget, you would upload your internal excel spreadsheet under this narrative. 2. Sponsor Guidelines o Main Menu < Edit > < Narrative > select < Other > from drop down list. o Title this < OTHER > narrative as SPONSOR GUIDELINES. o Upload sponsor specific guidelines for this proposal. 3. Proposal o Main Menu < Edit > <Narrative > select < Other > from drop down list. o Title this < Other > narrative as PROPOSAL. o You will use this narrative to upload ALL of your proposal documents (including those submitted online to the sponsor) or contract documentation for review. This is your actual application. o Scope of Work (if applicable) 4. Sponsor Signature Page o Main Menu < Edit > < Narrative > select < Other > from drop down list. o Title this < Other > narrative as SPONSOR SIGNATURE PAGE. o If an original signature by as Signing Official is NOT required, a signed copy will be uploaded into the proposal development record by ORA. o If an original signature by a Signing official is required, deliver a hard copy of signature page to ORA. Be sure to identify the Coeus proposal number that is associated with the hard copy along with the person to be contacted for pick up. 5. Principal Investigator (PI) Certification o Main Menu < Edit > < Narrative > select < Other > from drop down list. o Title this < Other > narrative as PI CERTIFICATION.

31 o Upload SIGNED certification for the Principal Investigator. 6. Clinical Research Supplemental Info Sheet (for commercially sponsored clinical research) o Main Menu < Edit > < Narrative > select < Other > from drop down list. o Title this < Other > narrative as SUPPLEMENTAL INFO SHEET.

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33 BUDGET INFORMATION Main Screen < Edit > select < Budget > o Select Budget screen appears. o Select < NEW >. NOTE: If you are using CoeusLite to complete all information, but are not developing your budget in CoeusLite, you must switch to Coeus Premium to input budgetary information on the Budget Summary Screen. Summary Tab o Enter Direct costs for each year under the Direct Cost Column. o Enter Indirect costs for each year under the Indirect Cost Column. Enter Facilities and Administrative Rate used o Change UR Rate Type tab to either MTDC or TDC o Use the < % Icon > change the default rate to the rate used for this proposal. Mark budget as Complete and Final. Return to Proposal Detail Screen Be sure you have a Green check for both the Narrative and the Budget.

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38 ROUTE FOR APPROVAL Once all items are completed, select < Action > and select < Submit for approval >. This will route your proposal to your Department or to ORA directly. If you need to see the routing, select < Action > and select < Show Routing >.

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