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					                                 PROPOSAL SUMMARY AND CERTIFICATION FORM (PROSUM)

                                                  COMPLETION INSTRUCTIONS

DATA FIELD                          DATA FIELD DEFINITIONS
                                 SECTION I - DEADLINE AND SUBMISSION INFORMATION
                                    The date by which the proposal must be submitted to the sponsor. Deadline dates can be found
Sponsor Deadline
                                    in sponsor's program guidelines.
                                    Indicate if the deadline is "receipt" (meaning proposal must be received by the date) or
Receipt/Postmark
                                    "postmark" (meaning proposal must be postmarked by the date).
                                    Fill in the six-digit transaction control number (TCN). Numbers can be obtained by going to
Proposal (TCN)# (Drop-down List)
                                    https://www-iisp1.its.yale.edu/tcn/
                                   If this is a YSM proposal select "M" in front of the TCN. Central campus proposals should be
    * M /C
                                   preceded by a "C".
                                   Once the proposal is signed by the Office of Grant and Contract Administration (GCA), select the
Submission Method (Drop-down List) appropriate delivery method to the sponsor. This is the submission method by which the
                                   proposal will be submitted by GCA to the sponsor.
     * Electronic                  If GCA will submit this application to the sponsor electronically, select this option.
     * US/Mail                     If GCA will submit this application to the sponsor via US mail, select this option.
     * FedEx                       If GCA will submit this application to the sponsor via courier service, select this method.
                                   If the department will pickup the signed proposal from GCA and submit it to the sponsor, please
     * Dept. Pick-Up
                                   choose this option.
                                   If the proposal will be submitted via another method not listed, please select this option and
     * Other
                                   specify in adjacent field.
Sponsor ID                         Indicate the sponsor's funding opportunity number, if applicable.
                                   If GCA has questions about the proposal, whom should GCA contact and what is their phone # /
Dept. Admin. Contact
                                   email address?
                                          SECTION II - PRINCIPAL INVESTIGATOR
Last Name                          Last name of the Principal Investigator.
First Name                         First name of the Principal Investigator.
Middle Initial                     If applicable, the middle initial of the Principal Investigator's middle name.
                                   Use Yale title, not role on proposed project.
Appointment Type                   PI Exemption ~ Review of Proposals from Individuals Who Require Special Permission to Serve
                                   as PI (YSM): http://www.yale.edu/grants.forms/index.html
Email Address                      The PI's Yale email address
                                   The PI's Yale net ID. This information can easily be obtained by searching the Yale Directory at
Net ID
                                   https://veritas.its.yale.edu/netid/FindNetID.do.
Department                         The PI's department or the name of the department that will administer the award.
Fax No                             The PI's Yale fax number
Phone No                           The PI's Yale phone number
                                   The 6-digit number used to identify the specific departmental unit that will have administrative
Award Owning Org #
                                   responsibility for this project.




 PROSUM INSTRUCTIONS                                       Page 1 of 12
                                 PROPOSAL SUMMARY AND CERTIFICATION FORM (PROSUM)

                                                 COMPLETION INSTRUCTIONS

DATA FIELD                             DATA FIELD DEFINITIONS
                                            SECTION III - PROPOSAL INFORMATION
                                       This should be the same as the title listed on the proposal and will be noted in Yale's permanent
Proposal Title
                                       records.
                                       For use with Oracle setup fields. Departments may choose a short title which is limited to 30
Award Short Name
                                       characters.
                                       The name of the agency or entity that will be providing the funds directly to Yale University.
                                       NOTE: if Yale University is proposing as a subrecipient on a proposal from ABC University to
Sponsor
                                       NIH, then ABC University should be listed as the sponsor, and the prime agency should be listed
                                       as NIH.
Sponsor Address                        Full Sponsor address

                                       The approximate dates for start and end of the project. Keep in mind that these dates are not
Total Budget Period                    binding in any way and are only meant to be an estimate. Actual start and end dates will be
                                       determined by the award document.

                                       If this proposal is a subaward to Yale, who is funding the prime award recipient? See example,
Prime Agency
                                       under "Sponsor" above.
                                       If this proposal involves federal pass-through, select 'yes'. If not, select 'no'. For this field,
                                       federal pass-through refers to Yale as the prime awardee of a federal sponsored project with the
Federal Pass-Through
                                       intent to pass-through some or all of the federal funds in a subcontract to another organization,
                                       OR Yale as the subrecipient of a prime awardee of a federal sponsored project.
Proposal Type (Drop-down List)
The American Recovery and Reinvestment Act of 2009 (ARRA) was signed into law February 17, 2009. This stimulus funding
carries with it extensive tracking and reporting requirements. The following three new Proposal Types have been added to assist
us with tracking these proposal submissions. The proposal types are as follows: ARRA-New, ARRA-Supplement, and ARRA-
Conversion. Definitions of these types are noted below. If your request for funding falls under the ARRA, please select the
applicable proposal type for your submission. If your proposal is not subject to ARRA funding, select from the list of non-ARRA
Proposal Types.
                                       This is a request for American Recovery & Reinvestment Act (ARRA) funds for a new funding
  * ARRA-New                           opportunity, in response to a specific ARRA RFA/RFP/PAS. Examples would include Challenge
                                       Grants, Shared Instrumentation Grants, and/or Construction grants.
                                       This is a request for ARRA funds to support an administrative or competitive supplement to an
  * ARRA-Supplement
                                       existing grant. These are supplements to current projects that are on-going at Yale.
                                       This is a request for ARRA funds to support applications that were already submitted but did not
                                       get funded. The agency has asked for JIT-like information to now fund the proposal with
  * ARRA-Conversion
                                       stimulus funding. Information that may be requested: revised budget, revised scope of work,
                                       updated other support, IACUC and/or HIC approvals.
  * New                                This proposal has never before submitted to this sponsor
                                       A request for additional funding beyond that previously committed by the sponsor (e.g. at the end
  * Renewal
                                       of a specific project period).
                                       Annual renewal materials needed to generate an additional year of previously committed funding.
  * Non-Competing Continuation
                                       (e.g. year three of a five year award).
  * Revised Budget                     This proposal/budget was submitted on an earlier date.
  * Resubmission                       If this proposal is a resubmission, please indicate the previous ProSum#.
  * Supplement                         Request for additional funding for a previously awarded project




 PROSUM INSTRUCTIONS                                       Page 2 of 12
                                    PROPOSAL SUMMARY AND CERTIFICATION FORM (PROSUM)

                                                    COMPLETION INSTRUCTIONS

DATA FIELD                               DATA FIELD DEFINITIONS
Award Type (Drop-down List)
                                         Anticipated award will result in a legal instrument which permits an executive agency of the
                                         Federal government to transfer money, property, services or other things of value to a grantee
  * Grant
                                         when no substantial involvement is anticipated between the agency and the recipient during the
                                         performance of the contemplated activity; Cost Reimbursable
                                         Anticipated award will be an agreement to provide research services under specified negotiated
  * Contract
                                         conditions in exchange for a specific deliverable. Cost Reimbursable or Fixed Price.
                                         Also referred to as a subcontract or subgrant. An award of financial assistance in the form of
                                         money, or property in lieu of money, made under an award by Yale to an eligible subrecipient or
  * Subaward                             by a subrecipient to a lower tier subrecipient. The term includes financial assistance when
                                         provide by any legal agreement, even if the agreement is called a contract. The appropriate
                                         terms and conditions of Yale's award are "flowed down" to the subrecipient .
                                         A financial assistance agreement used when substantial federal sponsor involvement is
  * Cooperative Agreement
                                         anticipated with the University during the performance of the project; Cost Reimbursable
Activity Type (Drop-down List)
  * Research                             To be used for general research project applications
                                         An individual fellowship application and/or institutional application that is for funding pre- and post-
  * Training/Education
                                         doctoral students
  * Career Development                   Mainly NIH "K" Awards
                                         Individual fellowship applications. Yale's Assurance of Compliance Certification of Individual
  * Fellowships                          NRSA Fellowships form (Tab 6) must be provided to GCA with all new competing and non
                                         competing applications and all prior approval requests for Individual NRSA Fellowships.
                                         Type of contractual agreement, typically in which a YSM faculty member conducts training at an
  * Affiliated Hospital Agreement
                                         affiliated hospital
                                         An institutional award, made in the name of a Center Director (i.e., the Principal Investigator), for
  * Center Grant                         the support of a large, interrelated research program, focused on a specific problem (e.g., NIH
                                         P50 and similarly type applications)
                                         Assistance for the support of a broadly based multidisciplinary research program that has a well-
  * Program Project
                                         defined central research focus or objective (e.g., NIH P01 and similar type applications)
  * Equipment                            Proposal is for support of equipment and related costs.
  * Service                              Any services provided to another agency including health assessments and social services.
                                         Proposal is limited to support of travel or conferences. Do not use for travel to conferences
  * Conference/Travel
                                         associated with a research project.
                                         Research projects that are designed to test the safety and effectiveness of therapeutic,
  * Clinical Trial                       diagnostic or preventative intervention in humans. A Clinical Trial Addendum (Tab # 5) must
                                         accompany the ProSum for all clinical trials.
Catalog of Federal Domestic              A CFDA # is required for all federal proposals (including subawards). It can be located in the
Assistance (CFDA) #                      agency's funding announcement.
Request for Award (RFA) # /Request       Enter relevant information about the sponsor's solicitation, such as the number, title or url. If the
for Proposal (RFP)#                      solicitation is not on the internet, please provide a copy to GCA with the proposal.




 PROSUM INSTRUCTIONS                                          Page 3 of 12
                                 PROPOSAL SUMMARY AND CERTIFICATION FORM (PROSUM)

                                                   COMPLETION INSTRUCTIONS

DATA FIELD                             DATA FIELD DEFINITIONS
                                                    SECTION IV - COMPLIANCE
                                Compliance Information NOTE: ALL FIELDS MUST BE COMPLETED
                                       Check 'yes' if the research will require the use of human subjects. Check 'no' if the research will
                                       not require the use of human subjects. If 'yes', check the location(s) where the human subject
                                       research will be conducted and indicate the HIC/HSC/HRRC protocol number under which the
                                       work will be conducted and its approval date. If approval has not yet been obtained, indicate
                                       „pending‟. Once notified that funding for this proposal is likely, or upon receipt of a “Just in Time”
                                       request, notify the IRB office that funding is imminent, provide the proposal (M/C) number listed
                                       on the Prosum and request that protocol-proposal congruency review be conducted for the
                                       applicable protocol(s). If the proposal will be associated with a pending IRB protocol(s), please
                                       submit the applicable IRB protocol(s) to the IRB Office noting the funding source information to
Human Subjects                         begin the required IRB review process, which includes conducting a protocol-proposal
                                       congruency review. If the proposal is associated with a currently approved IRB protocol(s),
                                       please amend the existing protocol(s) to include the proposed funding


                                         source so the IRB may conduct the required protocol-proposal congruency review. Policies,
                                         procedures and guidelines for use of Human Subjects can be found at http://www.yale.edu/hsc or
                                         http://info.med.yale.edu/hic/. Further information regarding protocol-proposal congruency for
                                         human subjects can be found at
                                         http://www.yale.edu/researchadministration/documents/ORAnewsletterJanFeb2009.pdf.
                                         Check „yes‟ if the research will require the use of animals. Check „no‟ if the research will not
                                         require the use of animals. If 'yes', check the location(s) where the animal research will be
                                         conducted. Once notified that funding for this proposal is likely, or upon receipt of a “Just in
                                         Time” request, notify the IACUC office via email (IACUC@Yale.edu) that funding is imminent,
                                         provide the proposal (M/C) number listed on the Prosum and request that protocol-proposal
                                         congruency review be conducted for the applicable protocol(s). If there is no applicable active
Animals
                                         animal protocol for the proposal to be linked to, submit the animal protocol to the IACUC office
                                         for the required IACUC review and the protocol-proposal congruency review. Be advised that
                                         deadlines for IACUC protocol review are applicable and available at http://www.iacuc.yale.edu/
                                         along with policies, procedures and guidance for the use of live vertebrate animals at Yale
                                         University. Further information regarding protocol-proposal congruency for animals can be found
                                         at http://www.yale.edu/oranewsletter/archive4/feature2.html.
                                         Check 'yes' to all that apply for the research. If the research involves the use of human
                                         embryonic stem cells, provide the Embryonic Stem Cell Research Oversight (ESCRO)
Other                                    Committee#. Refer to the University's policy on human embryonic stem cell research at:
                                         http://www.yale.edu/provost/html/escropolicy.html & Procedure 1350 PR01 at:
                                         http://www.yale.edu/ppdev/Procedures/hesc/1350PR.01hESCResearch.pdf
                                         Check 'yes' to all that apply for the research. Refer to export control guidelines at
                                         http://info.med.yale.edu/ysm/grants/policies/exportcontrols.html. Contact the Director,
Export Controls
                                         International Agreements and Export Control Licensing with any questions:
                                         donald.deyo@yale.edu
                                                   SECTION V - PROPOSAL BUDGET
Facilities & Administration (F&A) Rate   Indicate the rate used to calculate the F&A (also known as indirect) costs.
                                         The way in which the F&A amount was calculated. Base equals the total direct costs less any
Base
                                         required exclusions that are not subject to F&A costs.
                                         Standard list of exclusions from the total direct costs. See Yale's most recent F&A Rate
  * Modified
                                         Agreement: http://grants.med.yale.edu/proposal_development/pdf/rates2008.pdf
  * Total                                All direct costs are subject to F&A costs
                                         Flat dollar amount by the sponsor not based on amount of base. If the rate is a flat dollar
  * Administrative Costs
                                         amount, enter the dollar amount in the F&A field.
  * Equipment Excluded                   Total direct costs less equipment costs only.
  * Not Allowed                          F&A costs are not allowed by the sponsor's written policies.
  * Other                                Sponsor-driven F&A bases (e.g., sponsor will pay F&A costs but not on fringe benefit costs)
Directs                                  The total direct costs for each proposal budget period (usually annual).
F&A                                      The total F&A costs for each proposal budget period.




 PROSUM INSTRUCTIONS                                         Page 4 of 12
                                 PROPOSAL SUMMARY AND CERTIFICATION FORM (PROSUM)

                                                 COMPLETION INSTRUCTIONS

DATA FIELD                             DATA FIELD DEFINITIONS
                                        SECTION VI - PREDOMINANT WORK LOCATION
                                       The building where the predominance of the work will take place, even if it is off campus (e.g.,
Building Location
                                       name of institution/building/site). Note: For training grants, use location of PI.
Floor#                                 The floor number of the building location where the predominance of the work will take place.
Room#                                  The room number of the building location where the predominance of the work will take place.
                                       The location where the predominance of the project work will take place. Select one. (Only in
Work Location (Drop-down List)
                                       rare circumstances may more that one predominant work location be selected )
  * On Campus                          The predominance of the work will take place on campus
  * Off Campus                         The predominance of the work will take place off campus
  * Connecticut Mental Health Center
                                       The predominance of the work will take place at CMHC
  (CMHC)
  * The Anylan Center (TAC)            The predominance of the work will take place at TAC
  * Veteran's Administration
  Connecticut Health Care System       The predominance of the work will take place at the VA
  West Haven Campus (VA)
  * Yale New Haven Hospital (YNNH)     The predominance of the work will take place at YNHH
  * Boyer Center for Molecular
                                       The predominance of the work will take place at BCMM
  Medicine (BCMM)
  * (10 Amistad Street) Amistad        The predominance of the work will take place at Amistad
                                       Check 'yes' if new space or technology is required. If 'yes', explain the need for new space
Space/Technology Required?
                                       and/or new technology in this section. Use another page, if necessary.
            SECTION VII - PERSONNEL RESPONSIBLE FOR THE DESIGN, CONDUCT, OR REPORTING OF RESEARCH

                                     List the names and net IDs of all individuals responsible for the conduct, design or reporting of
Names
                                     the research or work.
                                     List the # of person months committed on this application for each individual indicated. Refer to
                                     Guide 1316 GD.01 Effort Percent /Calendar Month Conversion Tables
Effort
                                     http://www.yale.edu/ppdev/Guides/gc/1316GD.01EffortPercent_CalenderMonthConversionTable
                                     s.pdf
                                     Specify the home department affiliation for key/senior personnel. Any departments listed that
Home Department
                                     differ from the PI's home department must sign off on this ProSum (bottom of page 3).
                                  SECTION VIII - COST-SHARING & SALARY OVER-THE-CAP
                                     Check 'yes' if the proposal includes any cost-sharing which is required by the funder as a
                                     condition for application and/or award. Refer to Policy 1306:
Mandatory
                                     http://www.yale.edu/ppdev/policy/1306/1306.pdf & Procedure 1306:
                                     http://www.yale.edu/ppdev/Procedures/gc/1306PR.01CostSharing.pdf
                                     Check 'yes' if this proposal proposes cost-sharing not required by the sponsor. Any proposed
                                     cost-sharing not required by the sponsor, must be approved by the Dean/Provost). If yes, fill in
Voluntary                            the Yale award# and Yale Org. Refer to Policy 1306:
                                     http://www.yale.edu/ppdev/policy/1306/1306.pdf & Procedure 1306:
                                     http://www.yale.edu/ppdev/Procedures/gc/1306PR.01CostSharing.pdf
                                       Salaries of individuals identified with the project having an institutional base salary exceeding a
                                       sponsor-imposed salary rate cap must be accounted for. Indicate appropriate Yale Award and
Salary Over-the-Cap                    Yale Org numbers with $ amount. See Policy 1306:
                                       http://www.yale.edu/ppdev/policy/1306/1306.pdf & Procedure 1315 PR03:
                                       http://www.yale.edu/ppdev/Procedures/gc/1315PR.03SalariesaboveCap.pdf




  PROSUM INSTRUCTIONS                                       Page 5 of 12
                                     PROPOSAL SUMMARY AND CERTIFICATION FORM (PROSUM)

                                                       COMPLETION INSTRUCTIONS

DATA FIELD                                   DATA FIELD DEFINITIONS
                                                 SECTION IX - SUBRECIPIENT INFORMATION
If any of the work will be assigned to another organization, provide the requested information for each subrecipient. Use additional pages as
needed. Note: In order to approve a proposal with a subrecipient, GCA requires a detailed subrecipient budget and budget justification,
statement of work and letter of participation signed by the authorizing official of the subrecipient organization. Please contact your GCA
Grant & Contract Manager for questions regarding working with subrecipients.
Legal Name of Subrecipient
                                             Full Legal Name of Subrecipient Organization
Organization
                                             If GCA has questions about the proposal, whom should GCA contact at the subrecipient
Subrecipient Contact Name
                                             organization?
Subrecipient Organization Address,
                                             The address, phone # and fax # for the subrecipient organization
Phone and Fax Number
Foreign Organization                         Check 'yes' if the subrecipient organization is a foreign organization.
Subrecipient Annual Budget                   Detailed budget and budget justification required
                                             Check 'yes' if human subject research will be conducted at the subrecipient site. (complete
Human Subject Research
                                             Subrecipient Compliance and Certification Form, Tab # 4)
                                             Check 'yes' if animal research will be conducted at the subrecipient site. (complete Subrecipient
Animal Research
                                             Compliance and Certification Form, Tab # 4)
                                                SECTION X - CERTIFICATIONS & APPROVALS
                                             Each PI must sign and certify acknowledging their level of responsibility on the project and to all
                                             information contained on the Proposal Summary and Certification Form. Each PI must fulfill all
                                             requirements relative to conflict of interest, intellectual property, government debarment, health
                                             and safety and export controls. No "as per" signatures allowed.
                                             Yale's Policy on Conflict of Interest and Conflict of Commitment:
PI Signatures
                                             http://www.yale.edu/provost/html/coi.html
                                             Yale's Patent Acknowledgement Agreement:
                                             http://www.yale.edu/ocr/pfg/sample/documents/PPA_Sep2008.pdf
                                             Yale's Environmental Health and Safety Policies: http://www.yale.edu/oehs/policy.htm
                                             Yale's Guidance on Export Controls: http://www.yale.edu/grants/policies/exportcontrols.html
                                             Signatures must be obtained from each PI's:
                                              -- Chair or school director
Approvals/Signatures
                                              -- Dean or administrative head of unit
                                              -- Faculty mentor, if applicable (e.g., Mentored Career Development Awards)
Questions                                   Contact your assigned GCA Team with any questions: http://www.yale.edu/grants/contacts.html


Revision Date: 5/11/09




  PROSUM INSTRUCTIONS                                            Page 6 of 12
             Yale University                                                                                                     1304 FR.03 Proposal Summary & Certification Form
                                                               SECTION I - DEADLINE AND SUBMISSION INFORMATION
SPONSOR DEADLINE (mm/dd/yy):                                                                              RECEIPT            POSTMARK                 Proposal M/C#:
Submission Method                                                                       If Other (please specify)
Sponsor ID                                                                                  Dept. Admin. Contact                                                                         Ph:
For pick up, please contact (name, tel.# and email)
                                                                            SECTION II - PRINCIPAL INVESTIGATOR
Last Name                                                                                     First Name                                                                     M.I..         Suffix
Appt. Type/Title                                                                                                 Email                                                               Net ID
Department
Fax No.                                                                       Ph#                            Award Owning Org#
                                                                            SECTION III - PROPOSAL INFORMATION
Proposal Title:

Award Short Name                                                                                                                                    TOTAL Budget Period (mm/dd/yy)
Sponsor                                                                                                                                Proposed                              Proposed
                                                                                                                                       Start Date                            End Date

Address     (include contact person, tel.#, and
            email address)

Federal Pass Through                   Yes           No          Prime Agency (if Yale is subrecipient)
Proposal Type:                                                                     If proposal type is a revision, indicate former M/C#

Award Type:                                                      Activity Type:                                                 If Activity Type is a Fellowship ,
                                                                                                                               refer to Instructions. If Other,
RFA/RFP#                                                                                  CFDA#                                (please specify)
                                                                                   SECTION IV - COMPLIANCE
Yes No      (Please answer each question for the proposed research)
         HUMAN SUBJECTS (If yes, choose location(s))             LOCATION:         ON CAMPUS         OFF-CAMPUS               OFF-CAMPUS SUBAWARD

                             (If yes, provide HIC/HSC info:)         HIC/HSC#                                                                          Approval Date

                                                                     HIC/HSC#                                                                          Approval Date

         ANIMALS (If yes, choose location(s))                    LOCATION:         ON CAMPUS         OFF-CAMPUS VA            OFF-CAMPUS SUBAWARD (Domestic)               OFF-CAMPUS SUBAWARD (Outside US)

Yes No      OTHER                         Yes     No                           EXPORT CONTROLS
         Biohazards                                  Will this project involve the transfer or provision of equipment, materials, data or services outside of the US?
         Radioactive Substances
                                                     Will this project involve any foreign travel, especially foreign travel with a laptop computer or other electronic devices?
         Controlled Substances
                                                     Did the solicitation, RFP, RFQ, RFA, contract and/or discussions with the sponsor indicate potential use/involvement of
         Hazardous Chems./Materials                     publication restrictions or export-controlled items?
         Recombinant DNA
                                                     Will this project involve an agreement or collaboration with any foreign entity or foreign person (including
         Gene Transfer                                  foreign national graduate students or researchers)?

         Select Agents                               Will this project include the use of proprietary or export-controlled information or materials from the sponsor or a third party?

           Human Embryonic Stems
      (if checked, provide ESCRO #)

                                                                              SECTION V - PROPOSAL BUDGET
         F&A RATE                                 BASE                                            F&A RATE                                         BASE
  Periods                    One                            Two                             Three                           Four                        Five                Total All Periods
  Directs                                                                                                                                                                                      -
   F&A                                                                                                                                                                                         -
   Total                                  -                             -                                    -                        -                             -                          -
                                                                   SECTION VI - PREDOMINANT WORK LOCATION
Building Location                                                                  Floor#                 Room#
Work Location                                                                                                                                                Yes
                                                                                                   New Space/Technology required?
                                                                                                                                                             No
            SECTION VII - PERSONNEL RESPONSIBLE FOR THE DESIGN, CONDUCT OR REPORTING OF THE PROPOSED RESEARCH
                                                    PERSON MONTHS                                                               Annual                   VA MOU in             H.S.
                                                                                                                                                                                               PI Training?
NAMES                                 NET ID CALENDAR ACADEMIC  SUMMER                                   HOME DEPT.              COI?          Date       Place?            Training?




Date Logged In           Reviewer Assigned                            Log Type                       Date Returned to TA                  Data Entry by TA              Date Sent to Sponsor By Whom

Revision Date: 5/11/09                                    For Questions: gcacommunications@yale.edu                                                                                                 Page 1 of 3
                                              Click on PROSUM Page 2 tab below to complete the second page of this form.
         Yale University                                                            1304 FR.03 Proposal Summary & Certification Form
                                                                                    Proposal M/C#:                                               0
                                        SECTION VIII - COST SHARING & SALARY OVER-THE-CAP
   Yes     No       Mandatory: Cost sharing which is required by sponsor as a condition for application and/or award, e.g. institutional
                    matching on instrumentation grants, or require effort with no salary support. If yes, fill in source below.
                    Yale Award #                                        Yale Org                          Amt (all years)
   Yes     No       Voluntary: Proposed cost sharing not required by sponsor (must be approved by the Dean/Provost). If yes, fill in source
                    Yale Award #                                        Yale Org                          Amt (all years)
                    Salary Over-the-Cap
   Yes     No       Yale Award #                                        Yale Org                          Amt (all years)
                         SECTION IX - SUBRECIPIENT INFORMATION (attach additional sheets, if needed)
A Subrecipient Compliance and Certification Form (Tab # 4) must be submitted for each subrecipient prior to GCA's execution of the
subcontract. For NIH proposals, this form must be submitted no later than Just-in-Time (JIT).
Legal Name of Subrecipient Organization
Subrecipient Organization Contact                                                                                Phone:
Address                                                                                                          Fax:
Foreign Organization?            Yes       No
           Year            One                    Two                   Three                  Four                Five              Total
   Total Budget                                                                                                                        0
Human subject research at subrecipient site?            Yes        No
Animal research at subrecipient site?   Yes               No

Subrecipient Organization
Subrecipient Organization Contact                                                                                Phone:
Address                                                                                                          Fax:
Foreign Organization?            Yes       No
           Year            One                    Two                   Three                  Four                Five              Total
   Total Budget                                                                                                                        0
Human subject research at subrecipient site?            Yes        No
Animal research at subrecipient site?   Yes               No

Subrecipient Organization
Subrecipient Organization Contact                                                                                Phone:
Address                                                                                                          Fax:
Foreign Organization?           Yes        No
             Year          One                    Two                   Three                  Four                Five              Total
   Total Budget                                                                                                                        0

Human subject research at subrecipient site?            Yes       No
Animal research at subrecipient site?           Yes       No

                                                              SECTION X - CERTIFICATIONS
Principal Investigator/Co-Principal Investigator: We certify that the information contained on this Proposal Summary & Certification Form is true, accurate
and complete as of this date. Any false, fictitious or fraudulent statements or claims may subject PI and/or Co-PI to criminal, civil, or administrative
penalties. We accept responsibility for the scientific and administrative conduct of the project and will provide the required progress reports if a sponsored
agreement is awarded as a result of the application. We have completed all required Yale University faculty training, including Sponsored Projects
Financial Administration for Faculty (http://learn.yale.edu/ra)
  * Conflict of Interest (COI): By signing below, I/we have determined that all individuals responsible for the design, conduct or reporting of this research
  (listed in Section VII) have read and understand Yale's policy on Conflict of Interest and Conflict of Commitment, have made all required disclosures, and
  have disclosed any changes necessitated by this proposal. I/we further agree to comply with any conditions or restrictions imposed by Yale to manage,
  reduce or eliminate conflicts of interest.
  * Intellectual Property: In accordance with Yale University‟s Patent Policy, all personnel on this project including postdocs, students and visiting
  scientists, will have signed the University‟s Patent Acknowledgement Agreement prior to initiation of this project.
  *Debarment: by signing below the Principal Investigator/Co-Principal Investigator certify that neither the PI nor anyone proposed to work on this project
  are, to the best of my/our knowledge, excluded from participation in the federally funded activities as a result of government-wide suspension or
  debarment.
  * Health and Safety: I/we are aware of the potential environmental health and safety issues and hazards identified in this proposal, will share this
  information with staff and students, and will obtain applicable training, authorizations and equipment necessary to perform this work safely.
  * Export Controls: I/we have read and understand Yale‟s Guidelines on Export Controls and I/we will work with the GCA to ensure this project complies
  with the United States export control laws and regulations.

 Revision Date: 5/11/09                                                                                                                          Page 2 of 3
        Yale University                                                            1304 FR.03 Proposal Summary & Certification Form
                                                                                                            Proposal M/C#:                     0
Principal Investigator Signature:                                                                  Date:

Co-Principal Investigator Signature:                                                               Date:

Faculty Mentor:                                                                                    Date:
Department Chair/Dean (or Designee): I approve the attached proposal. It is within the total program and academic objective of the Department/School.
Adequate space is available or planned for the conduct of the project. The professional time allocation described therein is realistic. I have reviewed and
approve cost sharing commitments indicated in this proposal, or sought appropriate approval if cost sharing is voluntary. I will be responsible for assuring
that the necessary resources are made available. The information contained on the Proposal Summary and Certification Form is accurate and correct to
the best of my knowledge.

Department Chair or Dean:                                                                          Date:

Department Administrator: I certify that the budget and administrative information contained on this Proposal Summary & Certification Form and in the
attached proposal is complete and accurate to the best of my knowledge. If an award is made as a result of this proposal, it will be administered in
accordance with the terms and conditions of the sponsor and the University.

Department Administrator:                                                                          Date:

Other Department:                                                                                  Date:

Department Name:                                                                                   Date:

VA Approval:                                                                                       Date:

CMHC Approval:                                                                                     Date:




GCA - Central, 155 Whitney Avenue, Suite 214                                         GCA - YSM, 47 College Street, Suite 203
Ph:/Fax/Email: 432-2460/432-7138/grants@yale.edu                                     Ph:/Fax/Email: 785-4689/785-4159/contract.med@yale.edu
Revision Date: 5/11/09                                                                                                                          Page 3 of 3
                     Yale University                   Subrecipient Compliance and Certification Form

Section to be completed by Yale PI or Business Office :
Yale Prime Award Information
PI:

Proposal Title:

Prime Sponsor:
Subrecipient Information
Subrecipient organization:
Subrecipient PI:
Does the project involve research with human subjects at the subrecipient site? (Check below as applicable)

      Yes      No         If Yes , the subrecipient organization must complete Human Subject Protections section below and submit supporting
                          documentation

Does the project involve research with animals at the subrecipient site?

      Yes       No        If Yes , the subrecipient organization must complete the Use and Care of Animals section below and submit supporting
                          documentation

Sections to be completed by the above identified Subrecipient Organization , as applicable:
Human Subjects Protections Certification:

The Authorized Representative, by signing below, certifies that the body of research described in the IRB protocol has been reviewed relative
to the research described in the scope of work submitted to Yale University. Attach a copy of the IRB approval and complete the following:

IRB approval date:
Protocol number:
Institutional FWA #:
List personnel for which certification of human subjects protections training is required, and attach certifications of training for each individual
listed:




         Please check here if the IRB (of the subrecipient organization) has determined that the human subject research activity to occur at the
         subrecipient institution does not require IRB approval in accordance with 45 CFR Part 46 and subrecipient institutional policy.

Use and Care of Animals Certification:
The Authorized Representative by signing below, certifies that the body of research described in the IACUC protocol has been reviewed
relative to the research described in the scope of work submitted to Yale University. Attach a copy of the IACUC approval and complete the
following:
IACUC approval date:
Protocol number:
Institutional AWA #:
         Please check here if the animal research will be taking place at a facility outside of the United States

Conflict of Interest Certification: (section to be completed by the above identified Subrecipient Organization if prime award funding
source is PHS, AHA or ACS)
I certify to the best of my knowledge, all financial disclosures have been made related to the research activities that may be funded by or
through a resulting agreement, AND all identified conflicts of interest will be reported to Yale University's Office of Grant and Contract
Administration by submitting a report that explains if the conflict has or will have been appropriately managed, reduced or eliminated in
accordance with the subrecipient institution's conflict of interest policy prior to the issuance of an agreement and expenditures of any funds
under any resulting agreement.
Signature of Subrecipient Organization's Authorized Representative


The information contained on this Subrecipient Compliance and Certification Form is accurate and correct to the best of my knowledge.

Signature: Subrecipient Organization's Authorized Representative
Title:
Phone number:                                         Email Address:
Date:
                                            Clinical Trial Budget Summary

                          Please send this form in Excel format to your Contract Reviewer

    PI:                                                                         Prosum #:
    Sponsor:
    Protocol

    Note: In some cases the Sponsor’s final approved contract budget can be used in place of this page, but only when
    the Sponsor's budget already provides a complete summary breakdown of the direct, indirect, and total project costs
    as shown here. Please confirm whether this can apply to your project.

    Non-Billable Treatment Costs
    (Please adjust the items listed below to suit each specific protocol; items below are examples only)

    Item                                                        Direct            Indirect               Total

    Patient Costs (5 @ $6538)
    Patient Costs (5 @ $8500)
    Screen failures (4 @ $1200)
    other procedures (itemize)

    Administrative Startup
    other Administrative fees not included in ppt costs

    Pharmacy Setup
    Pharmacy Closeout
    Pharmacy Quarterly Fees ($550 x 8 qtrs)

    IRB initial approval
    IRB annual renewal
    IRB amendment

    Total:                                                        $0                 $0                   $0

    Additional Items - list any items for which a cost has been agreed but which might only occur
    under specific conditions and for which entering a total budget amount would not be appropriate

    Item                                                        Direct            Indirect              Total
    e.g. Liver Biopsy                                           $500               $150                 $650




    Note: PI Signature on Prosum certifies that items paid by Study Sponsor in this budget will not be
    billed to study subject or submitted for reimbursement under study subject's insurance coverage.




Clinical Trial Addendum
ProSum dated 5/11/09
                                   Yale’s Assurance of Compliance
                            Certification of Individual NSRA Fellowships
                       http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-007.html

The certification below is intended to fulfill the compliance requirement issued by the National
Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ) wherein Yale
University agrees to secure and retain written assurances from the Fellow and Sponsor(s) prior to
submitting an individual fellowship application to the PHS. While this assurance is not required as
part of the submitted application, it is a sponsor compliance requirement. Therefore, Yale must obtain
a unique signature and date from each Fellow and their Sponsor(s) for each submitted application.
This assurance must be available to the sponsoring agency or other authorized HHS or Federal
officials upon request.
This certification must be provided to the Office of Grant and Contract Administration with all new
competing and non-competing (progress reports) applications and all prior approval requests for
Individual NRSA Fellowships.
Sponsor Certification: I hereby certify:
 (1) that the information submitted within the application is true, complete and accurate to the best of
 my knowledge;
 (2) that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or
 administrative penalties; and
 (3) that I will provide appropriate training, adequate facilities, and supervision if a fellowship is
 awarded as a result of the application.
Fellow Certification: I hereby certify:
 (1) that the information submitted within the application is true, complete and accurate to the best of
 my knowledge;
 (2) that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or
 administrative penalties; and
 (3) that I have read the Ruth L. Kirschstein National Research Service Award Payback Assurance
 and will abide by the Assurance if an award is made, and that the award will not support residency
 training.




Fellow (signature)                                                 Date



Sponsor (signature)                                                Date




Sponsor (signature)                                                Date



Sponsor (signature)                                                Date

				
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