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REQUEST FOR PROPOSAL For Enterprise-wide Pre-Award and Compliance System (PACS) Issued December 5, 2014 The Research Foundation for The State University of New York 35 State Street Albany, New York 12207-2826 Copyright by The Research Foundation for The State University of New York. All Rights Reserved. December, 2014.

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Page 1: Section 1: General Information and Instructions - Web viewEnterprise-wide Pre-Award ... standard approach and architecture such as Service Oriented Architecture (SOA), data ... if

REQUEST FOR PROPOSALFor

Enterprise-wide Pre-Award and Compliance System (PACS)

IssuedDecember 5, 2014

The Research Foundation for The State University of New York35 State Street

Albany, New York 12207-2826

Submission Deadline: January 5, 2015 at Noon E.S.T.

www.rfsuny.org

Copyright by The Research Foundation for The State University of New York. All Rights Reserved. December, 2014.

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Table of Contents

Section Contents Page

Section 1: General Information and Instructions............................................................................................2A. Summary and Scope..........................................................................................................2B. RFP Proposal Submission and Due Date...........................................................................3C. Response to Inquiries/Bidder’s Conference........................................................................3D. Reserved Rights.................................................................................................................3E. Compliance with Laws and Regulations: Non-Discrimination, Equal Opportunity and

Affirmative Action Obligations.............................................................................................4F. Liability and Indemnification................................................................................................4G. Additional Terms and/or Conditions....................................................................................5H. Bidder Certification............................................................................................................. 6

Section 2: Proposal Requirements.................................................................................................................7A. Overview.............................................................................................................................7B. Mandatory Elements for Qualification.................................................................................7

Section 3: Selection and Evaluation Criteria and Timelines...........................................................................9A. General Selection Criteria...................................................................................................9B. Proposal Review Process Timeline....................................................................................9C. Evaluation Process and Criteria..........................................................................................9

Section 4: Business Requirements...............................................................................................................11A. Pre-Award.........................................................................................................................11B. Regulatory Research Compliance....................................................................................13C. System Integration............................................................................................................15D. Data Warehousing and Reporting.....................................................................................17E. Data Conversion, Maintenance, Support, Performance, Testing and Knowledge Transfer

Objectives......................................................................................................................... 18F. Cooperation with Independent Verification and Validation (IV&V)....................................19

Section 5: Implementation Strategy..............................................................................................................20Section 6: Attachments.................................................................................................................................21

Attachment A: Application for Contract with the Research Foundation for SUNY and Bidder Certification...........................................................................................................................212Attachment B: Overview of the RF’s Existing Business Systems.........................................214Attachment C: PACS Business Requirements (Detailed List)................................................29Attachment D: List of Requested Standard Reports...............................................................38

You are invited to submit a bid proposal to The Research Foundation for SUNY (RF) in response to this Request for Proposal (RFP). For more information about the RF visit our website @ www.rfsuny.org

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Section 1: General Information and Instructions

A. Summary and Scope

The purpose of this RFP is to solicit and evaluate bids to procure a pre-award and regulatory and research compliance administration software platform. The mandatory components of this RFP are for software license and implementation, including:

Data conversion Configuration Customization Testing Deployment Maintenance Support System performance management Training

For purposes of this RFP mandatory implementation is defined as the installation, data conversion, configuration, customization, out-of-the-box reporting, training, testing, deployment go-live support, and ongoing support and maintenance of a pre-award and regulatory research compliance administration software platform.

The optional components of this RFP include: System integration Data warehousing Ad-hoc reporting

Vendors may submit proposals including the mandatory components only or the mandatory components plus one or more of the optional components.

At the end of the project the RF would like a solution that is a scalable, multi-instance product suite for use by the RF’s central office and the 31 campus locations within the RF system that addresses core business processes in the following areas:

Pre-Award, including interactive proposal development Regulatory research compliance, including: Institutional Review Board (IRB - human subjects),

Institutional Animal Care and Use Committee (IACUC – animals), financial conflict of interest, Institutional Bio-safety Committee (IBC), export controls, and responsible conduct of research.

Workflow routing and approvals System integration, including the RF’s business applications and sponsor/third-party interfaces* Data warehousing* Reporting*

*Note: These components may be awarded to separate vendors depending on whether or not the winning bidder for this proposal included these optional components in their proposed solution.

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B. RFP Proposal Submission and Due Date

When submitting a proposal, you must:

1. Prepare a clearly readable document that provides information in the order requested and attach all required information.

2. Indicate any deviations from the specifications.

3. Sign the proposal. Your signature indicates full knowledge and acceptance of this RFP.

4. Submit five (5) hard copies of the complete proposal, one of which must have original signatures . Proposals should be sealed, clearly marked “Sealed Proposal: PACS Software Project,” and addressed to:

The Research Foundation for SUNY35 State Street2nd FloorAlbany, New York 12207-2026Attn: Dr. Hao Wang

5. Submit the proposal so that it is received by noon E.S.T. on Monday, January 5, 2015. This is a sealed bid. We will not accept electronic submission of proposals.Note: The vendors selected as finalists after review of the sealed bids will be able to submit materials for their product demonstrations electronically.

C. Response to Inquiries/Bidder’s Conference

Any inquiries about the requirements of this RFP or any apparent omission or discrepancy will be addressed during a bidder conference call on December 19, 2014 from 1 – 3 p.m.

All bidders are invited to participate to assure an equitable distribution of information. Please register by sending an e-mail to Min Yu ([email protected]). The RF also asks that you submit your questions in advance by close of business on Monday, December 15, 2014.

The bidder conference call information will be sent to those registered bidders.

If necessary, the RF representative will issue a written amendment to the Request for Proposal. Oral statements or instructions do not constitute an amendment to this Request for Proposal.

D. Reserved Rights

The RF reserves the right to:

1. Reject any and all proposals received in response to this RFP.

2. Request references and financial statements for the most recently completed fiscal year.

3. Contact any or all references.

4. Waive requirements or amend this RFP on notification to all bidders. Mandatory requirements may be eliminated if unmet by all bidders.

5. Adjust or correct cost or cost figures with the concurrence of the bidders if mathematical or typographical errors exist.

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6. Negotiate with bidders responding to this RFP within the requirements necessary to serve the best interests of the RF.

7. Begin contract negotiations with another bidder in order to serve the best interests of the RF, should the RF be unsuccessful in negotiating a contract with the successful bidder within an acceptable time frame.

8. Reject any or all portions of any offer, to negotiate terms and conditions consistent with the solicitation, and to make an award for any or all remaining portions.

9. Request clarifications from bidders for purposes of assuring a full understanding of responsiveness, and further to permit revisions from all bidders being considered for contract award, prior to award.

10. Waive minor irregularities.

E. Compliance with Laws and Regulations: Non-Discrimination, Equal Opportunity and Affirmative Action Obligations

The awarding of this business and continuation of services are subject to the requirements of Executive Order 11246 and 11375 and the rules and regulations of the Secretary of Labor (41 CFR Chapter 60) in promoting Equal Employment Opportunities.

The successful bidder must certify that it does not and will not discriminate or unduly favor any employees or agents on the basis of race, gender, national origin, religion or disability. As part of this contract, bidder must agree to comply with all applicable provisions of Section 503, Title V of the Vietnam Era Veterans’ Readjustment Assistance Act of 1972, as the same may be from time to time amended, together with all applicable regulations there under and all applicable provisions of Sections 503 and 504 of the Rehabilitation Act of 1973 (Public Law 93-516) as the same may be from time to time amended, together with all applicable regulations there under. F. Liability and Indemnification

The successful bidder will be responsible for the work, direction and compensation of its employees, consultants, agents and contractors. Nothing in the resulting agreement or the performance thereof by the successful bidder will impose any liability or duty whatsoever on the RF including, but not limited to, any liability for taxes, compensation, commissions, unemployment insurance, Workers’ Compensation, disability benefits, Social Security, or other employee benefits for any person or entity. The successful bidder shall hold harmless and indemnify the RF, their officers and employees from and against any injury, damage, loss of liability to persons or property resulting from or arising out of (a) the agreement, and (b) the acts, omissions, liabilities, or obligations of the successful bidder, any affiliate, or any person or entity engaged by the successful bidder as an expert, consultant, independent contractor, subcontractor, employee or agent.

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G. Additional Terms and/or Conditions

1. The following items will be incorporated into, and made part of, the formal agreement: (1) the RF’s RFP; (2) the successful bidder’s proposal.

2. In the event of any inconsistency in or conflict among the document elements of the agreement

described above, such inconsistency or conflict shall be resolved by giving precedence to the document elements in the following order: (1) the Agreement (2) this RFP (3) the successful bidder’s proposal.

3. Any terms that are attached or referenced with a submission shall not be considered part of the bid or proposal, but shall be deemed included for informational purposes only.

4. The resulting agreement shall be binding upon its execution by both parties.

5. The agreement may be revised at any time upon mutual consent of the parties in writing. Such written consent will not be effective until signed by both parties.

6. The relationship of the successful bidder to the RF shall be that of independent contractor.

7. Proposed prices should reflect all discounts including educational discounts.

8. The submission of a proposal constitutes a binding offer to perform and provide said services and cannot be unilaterally changed by the vendor. Such binding offer shall be firm and not revocable for a period of 180 days after the deadline for proposal submission and will continue thereafter until the successful bidder notifies the RF otherwise, in writing. Such deadline may be further extended by mutual agreement.

9. In the event the successful bidder uses partners, subcontracts or subcontractors, the successful bidder will remain responsible for compliance with all specifications and performance of all obligations under the contract resulting from this RFP.

10. The RF will not be liable for any cost associated with the preparation, transmittal, or presentation of any proposals or materials submitted in response to this RFP.

11. All bids or proposals submitted in response to the solicitation become and remain the property of the RF and should any doubt or difference of opinion arise between the RF and the bidder as to the items to be furnished or the interpretation of the provisions in the solicitation, the decision of the RF shall be final and binding upon all parties.

12. This RFP and the resulting contract shall be governed by the Laws of the State of New York.

13. Public announcements or news releases regarding this RFP or any subsequent award of a contract must not be made by any bidder without the prior written approval of the RF.

14. The successful bidder is responsible for compliance with all applicable rules and regulations pertaining to cities, towns, counties and State where the services are provided, and all other laws applicable to the performance of the resulting contract. The successful bidder shall provide all necessary safeguards for safety and protection as set forth by the United States Department of Labor, Occupational Safety and Health Administration.

H. Bidder Certification

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As evidence of bidders’ financial stability and ability to meet the service and requirements, Bidder MUST complete all information requested in Attachment A: Application for Contract with the Research Foundation for SUNY and Bidder Certification.

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Section 2: Proposal Requirements

A. Overview

This RFP asks bidders for a proposal to license and implement a pre-award and regulatory and research compliance administration software platform for the RF.

The requirements established by this RFP will be enforced in evaluating proposals. The bidder’s compliance with the format prescribed herein, as well as the bidder’s response to each specific requirement stated in the RFP will be considered during the evaluation process. Therefore, it is in the best interest of each bidder to become familiar with the content and format required.

B. Mandatory Elements for Qualification

Bidders must submit the following:

1. The completed and signed Attachment A: Application for Contract with the Research Foundation for SUNY and Bidder Certification. This form must have an original signature signed by an official authorized to bind the bidder to its provisions.

2. Describe how the features and functionality of your system provide the ability to meet the RF’s business requirements as stated in Section 4: Business Requirements of this RFP. Note: A secure online questionnaire covering the RF’s business requirements will be sent to those vendors moving forward with a proposal.

3. Your company’s most recently audited financial statements, as a separate attachment.

4. Describe your company’s ability to:

a. Provide the mandatory services related to license and implementation, including: Data conversion, maintenance, support, performance, testing and training support.

b. Deliver an implementation strategy as set forth by the RF.c. Interface with the RF’s business systems (refer to Attachment B: Overview of the RF’s Existing

Business Systems) and sponsor/third-party interfaces—including the technical architecture that is used.

5. Description of experience, resources and references to include the following information:

Experience:

a. Provide a brief company history and the year your entity was founded. b. Describe your experience in Higher Education and Sponsored Programs specifically.c. Describe your company’s size and commitment to Higher Education (including percentage of total

revenue derived from Higher Education clients and level of investment on pre-award and regulatory research compliance technology on an annual basis).

d. How much experience does your firm have with similar implementations? e. Tell us anything else about your company’s mission or vision that you think is important for us to

know.f. Include any other factors which you believe make your organization especially qualified to perform

this service.

Resources:

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a. Describe the background and experience of the specific personnel that will be assigned to the implementation.

b. Describe the specific personnel who will have overall responsibility for the project.c. Clearly state and specifically identify any subcontractors or subcontracts which are to be used to

deliver any of the services contained in the proposal. If any, approval of their involvement by the RF will be required.

d. Indicate resources/personnel that are required from the RF Information Services team and functional staff to implement and maintain the system.

e. Do you conduct annual users meetings?

References:

a. List the organization name, address, telephone number, and name of a contact person for three references with whom you have worked within the past two years and who can measure and attest to your qualifications specific to this area and to the persons you will assign to this project. Please provide a description of the services provided and the length of the relationship.

b. Confirm that, as part of this RFP process, your entity would be willing to participate in interviews with the RF. The specific date and location of such interviews will be determined subsequent to the review of proposal submissions.

6. Fee Proposal: The RF is seeking top quality services and expertise and understands that organizations that can offer such services are entitled to fair compensation for their services. At the same time, complete transparency in compensation for services is essential. Bidders must submit a separate financial exhibit (as an attachment to the RFP response) showing the fee for services within the scope of this RFP.

7. Information Security: Describe your ability to protect and secure campus data and to segregate campus data within one system.

8. Disaster Preparedness: The RF’s strategy is to use a third-party cloud computing solution such as Amazon Web Services (AWS). Describe the critical aspects of your disaster recovery plan in the event of a systems failure or other disaster at the primary processing site related to these services. Provide the date when the relevant aspects of the plan were last tested and the frequency by which the plan will be tested and updated.

9. Insurance: Bidder will at all times during the term of this contract, at their own expense, carry commercial general liability insurance and property damage insurance in the amount of $2,000,000 naming The Research Foundation for the State University of New York and the State University of New York as additional insured, and required professional liability insurance in the amount of $5,000,000. Excess policies can be used to meet required limits.

If you are not submitting a proposal the RF requests that you send an e-mail to Min Yu ([email protected]) stating the reason why you are not submitting a bid.

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Section 3: Selection and Evaluation Criteria and Timelines

A. General Selection Criteria

The contract award will be based on “best value” that optimizes quality, fees, and efficiency among responsive and responsible bidders. Proposals deemed by the RF to satisfy the requirement set forth in this RFP will be evaluated for the awarding of a contract.

Bidder must bid as requested. Award will be to one contractor in total. However, the RF reserves the right to award in its best interest. The award process is based on best value with the award being made to the highest scoring bidder.

If all requirements of bid submissions are met to the RF’s satisfaction, a contract agreement or purchase order may be issued after review and analysis of proposals and confirmation of qualifications, references, etc. Any contract or purchase order that results from this RFP will incorporate the terms and conditions of this RFP, unless otherwise agreed to in writing.

Termination of Contract: Failure of firm to meet the requirements of a contract shall constitute default. In such event, the RF reserves the right to cancel the contract for cause or convenience on written notice as further addressed in the resulting contract.

B. Proposal Review Process Timeline

December 19, 2014: Bidder conference call; Online business requirements survey opens

January 5, 2014: Proposals/responses due; Online business requirements survey closes

January 12, 2015: Top 2 finalists are selected and notified by close of business

January 20 – 21, 2015 Online vendor demonstrations by finalists

January 22 – 23, 2015 Steering Committee meeting and vendor leadership interview

January 26, 2015 Final vendor selected by close of business

February 26, 2015 Negotiated and signed contract in place by close of business

C. Evaluation Process and Criteria

All qualified proposals will be evaluated against the following criteria:

1. Cost effectiveness: The RF’s total cost for the mandatory components of the proposal, including: Software licensing, implementation costs, and ongoing maintenance costs.

2. Functionality: The degree to which the functionality of the solution meets RF business requirements.3. User experience: The satisfaction of the user experience. 4. Ability to deliver: Bidder’s ability to deliver the software and implementation according to the RF’s

implementation strategy and its ability for knowledge transfer and ongoing support.

A total of 100 points will be awarded based on the following:

Criteria Points subtotal

When to evaluate Who evaluates Point Total

Cost Effectiveness 30***

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Software License Fee* 10 Before demo Scoring; PLC**Implementation Cost 10 Before demo Scoring; PLCMaintenance and support costs for five years after go live

10 Before demo Scoring; PLC

Functionality 30Meets business requirements 30 Before and at

demoCampuses

User ExperienceGood user experience 10 At demo Campuses 10

Ability to Deliver 30Leadership team interview 10 After demo Steering

CommitteeAbility to maintain and support the system after go live

10 After demo Steering Committee

References 10 After demo Steering Committee

Total Score 100* For open source software, the software license fee would be the required consortium fee to obtain the right of use or access to maintenance and upgrades**PLC: Project Leadership Committee*** Bold numbers in the above chart indicate the scoring criteria that will be used to select the final two vendors who will proceed forward for the rest of the proposal review/selection process.

The top two candidates will be selected based on their total scores for the Cost Effectiveness and Functionality criteria.

The finalists will be invited to the RF for: A demonstration of their solution to RF and SUNY faculty and administrators. A management interview with their proposed project leadership team.

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Section 4: Business Requirements NoteRefer to Attachment C: PACS Business Requirements (Detailed List) for a complete list of the requirements that must be provided in the business solution.

A. Pre-Award

The RF wants to provide systems and tools that help principal investigators (PIs) increase their research capacity and performance.

Helping PIs author larger number of high quality proposals that are compliant with federal and state regulations as well as RF policies and procedures.

Reducing the administrative burden on researchers so they may generate more grant applications and focus more on creative ideas and innovations.

The following sections outline the RF’s business requirements for these pre-award functions:

1. Funding Opportunities

The proposed solution should include a user friendly interface that allows principal investigators (PIs) and research administrators identify funding opportunities, maintain HR profiles, and find potential collaborators. This includes the ability to search and match PIs with funding opportunities from all potential sources, including, but not limited to: Federal, state, industry and internal. Users should receive real-time notification of new opportunities that are available. It should be easy to maintain HR profiles and the profiles should connect with external sources of information including expertise, training, certification and salary. HR profiles should be available to be used to identify collaboration partners, develop budgets, and identify key personnel during proposal development.

2. Proposal Development

The proposed solution should allow PIs and research administrators to construct and collaborate on the creation of proposals. Standard templates and questionnaires, sometimes campus-specific, that help drive proposal development should be available. Research compliance areas including, but not limited to radiation safety, stem cell, FCOI, IRB and IACUC need to be identified early in the proposal process. Proposal development should include the ability to reuse common proposal elements. Searching on existing proposal documentation and attachments needs to be available. All aspects of collaboration need to be supported during narrative, abstracts, personnel identification and budget development.

HR profiles for staff identified during the funding opportunities should be readily available but not limited to PI for personnel and subcontractors. Additional HR profiles should be available during proposal to identify key personnel so the PI does not need to jump between applications to search and view expertise, training and certifications for individuals.

Budget development should be as basic or complex as needed, allowing for the upload or attachment of budget information. Standard budget templates, sometimes driven by funding opportunity type, should be made available as designed by both its central office and campus locations. Budgeting should use expenditure categories as defined in the RF Grants Management module, along with multiple fringe benefit and F&A rates and associated burden structures and rules for calculation. Multiple versions of budgets should be tracked for collaboration. Budgeting should include both paid and non-paid effort including identification of mandatory and voluntary cost sharing activities as well as multiple levels of credit distribution to faculty and organizations.

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Collaboration with subcontractors is also included during proposal development. This includes risk analysis of potential subcontractors. Once vetted, subcontractor could be part of proposal development and will need access to the application.

3. Institutional Routing and Approval

The proposed solution should handle the routing of proposals through the organizational unit hierarchy, including complex rules with multi-step, delegated access and notification requirements. The routing and approval process should allow for flexibility, adaptation and collaboration throughout. As comments, feedback and collaboration occur during the approval process, adjustments to the routing path could change and need to be flexible. Multiple users should be able to work on the proposal in a controlled environment during this process and allow for redirecting of approvals to occur when appropriate. The history and monitoring of progress of proposal through the routing and approval function should be available to PI and administrators.

4. Submission to Sponsor

The solution should provide the ability for various types of submission—electronic, e-mail and paper-based—with tracking of submission status. Grants.gov is used often so the solution needs to interface with Grants.gov and offer system-to-system submission that is as easy as clicking a button. Tracking the status of any submitted proposal should be readily available for monitoring. The solution should capture sponsor confirmation of the receipt, potential resubmission, deadlines, dates and updates as part of the history of the proposal.

5. Sponsor Review, Negotiation and Acceptance

The proposed solution should offer negotiation tracking to record any amendments or changes made to the award. There are many collaborators from various departments, including compliance offices and outside entities, so flexible collaboration is imperative. The RF needs the ability to load agreement templates that are designed by both its central office and campus locations. All actions taken, communications and annotations, need to be tracked and sometimes controlled—not every collaborator should have access to update or even view all information. The history and monitoring of progress from proposal through sponsor review, negotiation and acceptance should be available to PIs and administrators.

6. Award Establishment

The proposed solution should offer the ability to transfer proposal information needed for account establishment to the RF Grants Management Oracle module. This transfer of information should include both sponsored and non-sponsored proposals. Once an award is created in the RF Grants Management Oracle module specific award, project and task information needs to be sent back to the pre-award and regulatory research compliance system to complete the connection between the systems.

7. Close-Out

The proposed solution should offer the ability to transmit close-out information from the RF Grants Management Oracle module to the proposed solution.

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B. Regulatory Research Compliance

The RF, as a grantee institution receiving federally sponsored awards, and the State University of New York (SUNY) campuses where the research (sponsored and non-sponsored) is conducted are responsible to assure due diligence compliance with the U.S. federal government statutes and regulations that apply to the conduct of research. The research compliance areas are heavily regulated—often by several federal government agencies—and include:

1. Protection of human subjects 2. Protection of animal subjects3. Disclosure of financial conflict of interest4. Identification of hazardous/select agents and toxins5. Identification of export control situations – and licensing (if appropriate)6. Development of a responsible conduct in research program

1. Protection of Human Subjects

In brief, the campus Institutional Review Board (IRB) assures that all sponsored and non-sponsored research involving human subjects, including vulnerable populations (e.g., children), is in compliance with federal government statute (e.g., The Public Health Service Act) and regulation (e.g., Department of Health and Human Services). The sanctions for noncompliance (e.g., civil and criminal penalties) and potential damage to institutional reputation/integrity are significant/severe.

The functions the business solution must provide include, but are not limited to: Tracking and monitoring the IRB membership, identifying IRB member terms; routing phases for protocols between/among various campus offices; identifying different protocol phases (e.g., continuations); identifying different types of protocol review (e.g., exempt, expedited); documenting protocol approval; sending impact notifications (e.g., stop payment); connecting to other impact areas (e.g., biosafety); documenting the completion of applicable trainings; and assuring confidentiality is maintained.

2. Protection of Animal Subjects

In brief, the campus Institutional Animal Care and Use Committee (IACUC) assures that all sponsored and non-sponsored research that involves the use of, or intended use of, vertebrate animals in research, experimentation, testing, training, or related purposes is in compliance with federal government statute (e.g., The Animal Welfare Act) and regulations (e.g., Department of Agriculture). The sanctions (e.g., civil and criminal penalties) and potential damage to institutional reputation/integrity are significant/severe.

The functions the business solution must provide include, but are not limited to: Tracking and monitoring the IACUC membership; identifying IACUC member terms; routing phases for protocols between/among various campus offices; identifying different protocol phases (e.g., renewals); identifying different types of protocol review; documenting protocol approval; sending impact notifications (e.g., approval to order animal species - purchasing); connecting to other impact areas (e.g., facilities for inspections); documenting the completion of applicable trainings; and assuring confidentiality is maintained.

3. Disclosure of Financial Conflict of Interest

In brief, the campus assures that all persons responsible for proposing, conducting, and reporting sponsored research are required to disclose the existence of certain financial interests. The campus is required to review the disclosures to determine if any potential conflict of interest exists, and to establish mechanisms to manage, reduce or eliminate the conflict. The originating authorities for the regulations are the National Science Foundation and the Public Health Service. The sanctions for noncompliance are significant.

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The functions the business solution must provide include, but are not limited to: Supporting a repository for disclosures, identifying institutional responsibilities; connecting financial disclosures to institutional responsibilities; connecting to other impact areas (e.g., research compliance -IRB); sending impact notifications (e.g., post award); documenting the completion of applicable trainings, and assuring confidentiality is maintained.

4. Identification of Hazardous/Select Agents and Toxins

In brief, the campus Institutional Biosafety Committee (IBC) assures that all sponsored and non-sponsored research using an identified hazardous/select agent or toxin is in compliance with federal government statute (e.g., The Agricultural Bioterrorism Protection Act) and regulations (e.g., Centers for Disease Control and Prevention). The sanctions (e.g., civil and criminal penalties) and potential damage to institutional reputation/integrity are significant/severe.

The functions the business solution must provide include, but are not limited to: Tracking and monitoring the IBC membership; identifying IBC member terms; routing phases for reviews/approvals among various campus offices; identifying different and specific requirements (e.g., radiation, biohazards); connecting to other impact areas (e.g., research compliance - IRB); documenting the completion of applicable specific trainings (e.g., select agents, infectious agents); and assuring confidentiality is maintained. 5. Identification of Export Control Situations – and Licensing (if appropriate)

In brief, the campus assures that all sponsored and non-sponsored research that includes potential export control situations and impacts are identified. This includes but is not limited to: The export of controlled technical information to a restricted country/person; the transfer of deemed export services to a foreign national; and the transfer of funds to an embargoed country. Compliance is required with federal government statute (e.g., The Export Administration Act) and regulations (e.g., Department of Commerce). The sanctions (e.g., civil and criminal) for noncompliance are significant/severe.

The functions the business solution must provide include, but are not limited to: Identifying the different federal government requirements (e.g., three agencies) and the applicability; developing standard questions to trigger initial review (i.e., proposal submission); routing phases for license review/approval among various campus offices (if applicable); connecting to other impact areas (e.g., award establishment, post award); integrating with other impacted system modules (e.g., human resources/personnel); and assuring confidentiality is maintained.

6. Development of a Responsible Conduct in Research Program

In brief, the campus develops a campus-specific Responsible Conduct in Research (RCR) program to assure that the practice of scientific investigation is done with integrity. The program involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research. The originating authority is the National Institute of Health. The sanctions for noncompliance are customary to a grantee institution (e.g., auditable findings/remediation).

The functions the business solution must provide include, but are not limited to: Documenting the campus-specific program components; developing a schedule to identify and document that the various trainings associated with the campus-specific program (e.g., IRB, IACUC, FCOI) are completed – as applicable; and connecting to other impact areas (e.g., human resources). C. System Integration

The RF gathers data from many sources throughout the research life cycle, and pre-award and post award activities require many of the same data elements. The RF needs to integrate this data to improve our efficiency by eliminating duplicate entry and reducing data entry errors. The integration of data from different sources is

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also part of our data management lifecycle and is needed to conduct the data analysis that supports the RF’s decision-making process.

The bidder’s solution must allow for system integration between the bidder’s product and the RF’s current pre-award and post award systems and its reporting environment. The bidder’s solution is expected to adhere to industry standards for data and application integration. Standard integration framework such as Service Oriented Architecture (SOA) should be employed and standard data interfaces should be part of the solution. The solution must also contain the necessary protocols to extract, insert and/or attach information from third-party or Internet-based data sources.

The RF requires the following:

Funding Opportunities

1. Solution should provide the ability to export and import data to update faculty profiles.

Proposal Development

1. Solution should provide a protocol for the production of a flat file for use of exporting data from software systems such as Oracle EBS, third-party software and Oracle OBIEE to the bidder’s software such as:

a. Integrating HR information in all pre-award modules for each of the campuses participating in this project, with ability to interface cost structures and data such as personnel cost data, multiple department and center affiliations, bio-demographical information, educational qualifications, compliance HR data and indirect cost structures.

b. Integration of Oracle EBS, third-party software code tables for use in production of the pre-award proposal such as expense codes, sponsor, training, effort reporting, F&A codes, vendor (supplier) information, etc.

c. Integration of award, project and task information, including closing information back to vendor’s pre-award software.

2. Solution should provide ability to access Oracle EBS, OBIEE or third party software data information for use in proposal such as supplier file, sponsor files, expense codes, HR data, etc.

3. Each import and export should facilitate data conversion and ongoing pertinent information from existing RF sources and third-party systems including attachments:

a. COEUS (pre-award information, regulatory research compliance, subcontracts, award, negotiations)b. INFOEDc. Microsoft Excel based filesd. Microsoft Access based filese. Microsoft Word based filesf. IRBNET(human subjects, animal use, bio safety, stem cells)g. OSPREY(COI)

4. Solution should provide the capability to attach information from Oracle EBS, third-party software and internet based systems. The internet based systems should include compliance information that could be added as an attachment.

5. Solution should provide integration from third party and internet based compliance systems into vendor’s software solution.

6. Solution’s integration method should adopt industry standard approach and architecture such as Service Oriented Architecture (SOA), data dictionary, enterprise service bus, etc.

7. Solution should allow for monitoring and support current technologies such as XML, JSON, SFTP and REST Web services.

8. Connection to data source/database and data model and separation of data by campuses, row level security by campus.

9. Daily/real time interface with CITI training/trainee information.

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Institutional Routing/Approvals

1. Solution should support all campus approval hierarchy utilizing HR Org Structure that exist in Oracle EBS and campus based software

Submission to Sponsor

1. Solution should support system to system integration for submission/resubmission of proposal to sponsor.

Sponsor Review, Negotiation and Acceptance

1. Solution should support the ability to attach additional information necessary to complete the negotiation and acceptance.

2. Solution should provide the ability to upload documents from a variety of sources.3. Solution should provide the integration with email for approvals and correspondence to all engaged parties.

Award Establishment

1. Solution should provide a protocol for the production of a flat file for use of importing data to software systems such as Oracle EBS, third-party software and Oracle OBIEE.

2. Porting award and proposal information from pre-award to the RF’s post award Oracle business applications once the proposal is successfully funded:

a. Includes budget, personnel, department credit distributions, person credit distributions, title, sponsor, dates, installments, terms and conditions, F&A base, abstracts, effort, billing terms, reporting requirements, award notes, and references (e.g., human subject approvals, conflict of interest).

b. Standard approach to integrated data across systems and make data available for RF Report Center

3. Solution should provide the capability to attach information from Oracle EBS, third-party software and internet based systems. The internet based systems should include compliance information that could be added as an attachment.

Close-out

1. Solution should provide the transmission of closeout information including closure dates to the vendor’s pre-award system.

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D. Data Warehousing and Reporting

The RF wants to provide its users with robust reporting capabilities directly from the software solution and from the RF’s existing reporting solution—the RF Report Center.

The RF’s current pre-award solution does not provide standard out-of-the-box reports and there is a limited set of data in the data warehouse that is available to the user community for ad-hoc reporting. The RF wants the selected solution to provide many standard reports directly from the software application to the users. We need to build a strong data warehouse that will encompass all existing data points from the application, since users often get requests for data that might not be met by standard reports from the application.

To create a data warehouse the RF needs access to all application tables via data extract on at least a nightly basis. The RF can then enhance its existing reporting solution—the RF Report Center—to provide users with strong reporting capabilities that include dashboards, reports, and flexible ad-hoc query ability. These data extracts will also be used to feed campus-specific data warehouses and other campus ancillary systems.

To meet these reporting needs the RF identified business requirements in the following sections:

1. Standard and Ad-hoc Reporting2. External System Integration3. Security4. Documentation

1. Standard and Ad-Hoc Reporting

The proposed solution should provide users with as many out-of-the-box standard reports as possible. A listing of the RF’s requested standard reports is included in Attachment D: List of Requested Standard Reports. The new software should provide access to software database tables on a nightly basis to provide an extract of data to build our data warehouse. This nightly feed needs to include all data points from the software. The RF’s preference would be for any software product to integrate with Oracle Business Intelligence Enterprise Edition.

2. External System Integration

Any new software solution should successfully integrate with other systems and tools (e.g., ETL tools, Microsoft Excel, Microsoft Access, Oracle RDBMS, etc.). The solution should assimilate metadata from ETL tools from other vendors, including Informatica. Also, metadata should segregated by campus in case of multi-campus instances.

3. Security

Any new software solution should protect standard reports delivered through the software from unauthorized users. Also, the solution should allow for single sign-on access based on Shibboleth/InCommon and allow for multiple identity providers in one instance.

4. Documentation

The proposed solution should include providing the RF with a full, detailed data dictionary that outlines all data points by module to help with the creation of training materials.

E. Data Conversion, Maintenance, Support, Performance, Testing and Knowledge Transfer Objectives

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The RF’s existing pre-award and regulatory research compliance system contains multiple years of data for many campuses. The RF will require in its contract that existing data be converted to the new pre-award and regulatory research compliance system prior to launch in order to provide continuity.

The new system must: Be easily maintained Allow for cost-effective support Deliver high performance

The selected vendor must have sound financial strength and long-term sustainability, including: A clear support model for configuration, customization, and routine release management. Clearly defined pricing structures for configuration, customization, release management, and continuous

training and upgrade. Ample documentation, including manuals for users, administrators and developers.

Software and system maintainability is defined as the low and tolerable degree of difficulty for changes that can be made to the software and system. Changes can include bug correction, adaptation of a new RF business requirement or process, expansion to include new features and functionalities, and integration with other sister systems within the RF. Fulfillment of these change requests should be supported by a clearly defined Service Level Agreement (SLA).

The estimated RF user base is about 5,000 across 31 campuses. At any given time the RF expects that approximately 100 users will simultaneously access the system with this figure increasing to 250 during peak times. The PACS should deliver a speed of page refresh less than 5 seconds during both regular and peak times.

The selected vendor is expected to provide sufficient test plans for User Acceptance Test (UAT), system integration test, performance test, data integrity test and inter-instance segregation test.

The RF expects the selected vendor to transfer necessary knowledge and provide training to RF staff, including, but not limited to:

Technical knowledge of architecture and applications. Daily care and maintenance of the system. Third-party software required to support the system. Interfaces between the new system and other RF systems. PACS database. PACS modules. PACS administration.

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F. Cooperation with Independent Verification and Validation (IV&V)

This project will be a significant multi-year investment that is cross-functional and cross-campus. To assure its success the RF will acquire, through a competitive RFP process, the services of a separate vendor to provide Independent Validation and Verification (IV&V) services.

The IV&V vendor will assist the RF by: Providing quality assurance services during the project. Determining if deliverables are acceptable, and thus eligible for payment, during User Acceptance

Testing. Assuring that a full range of performance standards are met by the winning bidder, including, but not

limited to:o Information securityo Data integrityo Data conversion completeness and accuracyo System availabilityo System performanceo Defect resolution speed and yieldo Availability and quality of supporto Timeliness of deliverables

Any bidder that is awarded the contract for this RFP must withdraw their IV&V bid if they submitted one.

Performance Standards shall be negotiated and finalized during contract negotiation with the winning bidder. The winning bidder will be required to engage and support the IV&V vendor for fulfilling routine audit and documentation of performance standards. The winning bidder will track and submit all relevant data and reports required by the IV&V vendor.

In addition to assist Performance Standards, The IV&V vendor is expected to:

Review and evaluate deliverables. Independently report on the project status. Monitor the winning bidder’s quality management processes. Assess implementation processes. Monitor knowledge transfer. Provide ongoing risk management. Assess system testing.

The winning bidder is expected to fully cooperate with the IV&V vendor to fulfill the above functions.

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Section 5: Implementation StrategyThe RF’s desired implementation strategy is illustrated below:

Pilot Implementation

The vendor software will be implemented within 45 calendar days, on or about April 15 th, 2015, in a centralized cloud environment for two or more of our campuses. The vendor software will also be installed in a centralized cloud environment as a development sandbox for all campuses. This pilot arrangement is to demonstrate that:

1. The software of choice can be installed out of the box and largely meets our business requirements.2. The software of choice can be installed and operated securely in a cloud computing environment.3. The software of choice can allow data conversion from existing RF systems and largely meets the RF’s

data conversion needs out of the box—such data conversion should not be cumbersome.4. The vendor of choice can provide basic training to our campuses for adoption of the software.5. The software of choice can provide the foundation for multi-tenancy.

First Release of Customization and Configuration

12 months after the pilot implementation, the vendor of choice will customize and configure the software to meet the majority of our business requirements including all high priority requirements. This new release will replace the pilot install for those pilot campuses and become the system of record for the RF’s pre-award and regulatory research compliance system (PACS). During this release, knowledge transfer and broader training will happen.

Deployment to All Campuses

All other campuses will access and use the PACS Release 1. During the roll-out, the ability of regular releases and routine updates will be tested and certified and the support model will be established.

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Section 6: AttachmentsAttachment A: Application for Contract with the Research Foundation for SUNY and Bidder Certification

Attachment B: Overview of the RF’s Existing Business Systems

Attachment C: PACS Business Requirements (Detailed List)

Attachment D: List of Requested Standard Reports

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Attachment A

APPLICATION FOR CONTRACT WITH THE RESEARCH FOUNDATION FOR SUNY AND BIDDER CERTIFICATION

PROGRAM TITLE: Pre-Award and Regulatory Research Compliance Administration Software Platform

BIDDER NAME: (company):______________________________________________________

BIDDER CONTACT NAME:__________________________________________________________

ADDRESS: _____________________________________________________________________

TELEPHONE: ( ) ______________________ FAX NUMBER: ( ) _________________________

EMPLOYER’S FEDERAL ID # _____________________ E-MAIL ADDRESS: _____________________

Bidder Certification

1. Is the price quoted the same as or lower than that quoted other corporations, institutions or governmental agencies for similar service and/or like equipment or supplies?Yes: _____No: _____ If no, explain:

2. Does your firm agree that all presentations and materials will be free from racial, religious, or sexual bias?Yes: _____No: _____

3. Are you or any officer of your organization or any part owning or controlling more than 10 percent of your stock if you are a corporation or any member if you are a firm or association, an officer or employee of the Research Foundation for SUNY or of a public benefit corporation of the State of New York?Yes: _____No: _____

4. Within the past five years has your firm, any affiliate, any predecessor company or entity, owner, director, officer, partner or proprietor been the subject of a government suspension or debarment?Yes: _____No: _____ If yes, explain:

Compliance with RFP Conditions and State and Federal Laws I (we), the undersigned affirm the bidder is willing to comply with all the conditions set forth in this Request For Proposal, and with all applicable laws of the State of New York and the Government of the United States.

Willing To Contract I (we), the undersigned affirm the bidder understands that a separate contract will be established which will fully detail each party’s responsibilities in relation to the services requested by this RFP.

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I (We), the undersigned, attest that I am (we are) authorized to bind the bidder to the provisions of the attached

proposal.

NAME AND TITLE OF INDIVIDUAL OR FIRM’S OFFICER AUTHORIZED TO SIGN CONTRACT:

(PLEASE PRINT OR TYPE)

DATE: _________________ SIGNATURE: ____________________________________________

NAME AND TITLE OF PROJECT DIRECTOR (IF DIFFERENT FROM ABOVE):

(PLEASE PRINT OR TYPE)

DATE: _________________ SIGNATURE:_____________________________________________

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Attachment BOverview of the RF’s Existing Business SystemsThe RF uses various systems to conduct all business activity. This attachment provides a high-level overview of the business systems the RF uses in these categories:

A. Pre-AwardB. Regulatory Research ComplianceC. Post Award ManagementD. Enterprise Reporting

A. Pre-Award

Summary

The University at Albany, Binghamton University, University at Buffalo (UB), Stony Brook University, SUNY ESF and Upstate Medical University currently use an electronic pre-award and regulatory research compliance software system. There are roughly 5,000 individuals who have access to this system.

The system provides pre-award data entry, approval routing, and submission of proposals for several campuses. It has functionality for award tracking, negotiations, regulatory research compliance, (e.g., Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC)), subaward monitoring, and conflict of interest management. It also supports automated proposal submission to Grants.gov and other federal agency applications.

There are two interfaces used by campus staff, including: A web-based version that allows principal investigators (PIs) and research administrators to view and

create proposals, input budgets, complete regulatory research compliance questionnaires, and submit proposals for approval.

A full-featured application interface for research administrative staff to complete special requirements for institutional approval of proposals, additional budgeting functionality, and the ability to view institutional proposals and awards. This version is also used by system administrators to manage the system’s functionality.

The remaining campuses use a variety of tools to track pre-award data, including: Microsoft Access Microsoft Excel A custom pre-award form in the Oracle business applications Paper InfoEd PDF/Smart Forms E-mail

Hosting/Administration

The campuses who use the current electronic pre-award and regulatory research compliance software system share a common production instance that is hosted at UB. There are four database instances that include development, training, quality assurance and production.

These instances are supported during regular business hours, Monday through Friday, by UB’s Administrative Computing Services (ACS) group. Routine maintenance and regular backups occur outside of regular business hours.

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Modules Available in Current System

The decision to adopt the current system was based on many factors. The most important factor was the flexibility of the system to meet the individual needs of the campuses—whether university center, medical school or comprehensive college. Currently, the various modules available for implementation include:

The Proposal Development module allows PIs and research administrators to construct and route complete proposals from their desktop computers. Significant Proposal Development components include detailed cover-sheet information, Proposal Personnel, Budget, Narrative, Questionnaires, and Certifications. The Proposal Development module is integrated with centrally supported database information maintained in the Sponsor table (list of sponsors), Person table (updated by HR), Organization table (list of peer institutions for performance sites and subawards), and Rolodex table (list of outside contacts). These extensive data tables are easily accessed via searches, and the resulting data is consistently applied to each proposal. This module allows for proposals to be submitted to sponsors electronically.

The Institute Proposal contains summary data of proposals that have been approved and submitted to sponsoring organizations. While works-in-progress are stored and edited in the Proposal Development module, only complete submitted works are tracked and stored in the Institute Proposal module. Each proposal is assigned a unique identifier once it has been officially authorized by the organization prior to submission to a sponsor. Through this identifier the user can view basic data on funding source, title, department, PIs, and the amount proposed. Institute Proposal records may be modified to update pertinent information, such as the status of intellectual property review or special review status. Once a proposal is funded, the data in the Institute Proposal record may be used to form the basis of the Award module record or may be linked to an existing award.

The Institutional Review Board (IRB) module allows campuses to electronically submit, review, and monitor IRB protocols. This also allows the protocol and grant proposal to be linked, making the information easily accessible to the compliance and sponsored programs offices, enabling regulatory research compliance review to be more efficient.

The Subcontract module provides campuses with a subrecipient monitoring tool, tracking detailed information on subaward agreements, and maintaining historical information for the life of the award.

The Negotiation module allows sponsored programs offices to track negotiations for individual proposals and stand-alone contracts, which provides administrators with a tool to keep notes and track progress of a negotiation, facilitates sharing of electronic fields, and generates status reports.

The Conflict of Interest module allows users to complete and maintain all conflict of interest and financial interest disclosures. The module allows for flexibility with disclosure submission requirements across the campuses. Regulatory research compliance boards can review and track potential conflicts through the resolution.

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Support of Current System

Different levels of support and service are required across campuses using the same module because each module is adaptable for local requirements. Each campus provides functional support for their own campus administration, including items such as maintaining user accounts, unit hierarchies, F&A rates, and supporting other operational functions specific to their instance.

There are other functional maintenance issues that are maintained at the campus level that demand a certain degree of technical know-how, such as maintaining routing rules, validation rules, routing maps, questionnaires, and customizing style sheets for campus specific templates. While each campus is responsible for maintaining these items, a consortium of users from the larger campuses relies on the system administrator and application administrator at UB and a RF business analyst.

Even though the existing system is installed, hosted and managed at UB there are many integration points between the host servers at UB and servers at each of the campuses. These integration points are necessary to ensure the system uses the most recent and accurate person-data from campus-specific sources, as well as providing campus authentication of user log-in credentials. Each campus and RF central office IT Services provides technical support for the acquisition, formatting and delivery of person-data to the host servers at UB, as well as providing support for the coordinated authentication of user log-in credentials via a campus LDAP server or OID.

B. Regulatory Research Compliance

The RF’s existing system and processes do not include many of the features and functionality desired in a comprehensive regulatory research compliance system. The regulatory research compliance areas listed below need to be linked to pre-award, post award, compliance and other campus offices (e.g., purchasing) to make the information easily accessible. This will enable the campus sponsored programs and research compliance offices’ review processes to be more efficient and maintain confidentiality.

FCOI (Financial Conflict of Interest) includes annual disclosures, identification of financial entities, and links between financial entities and proposals and awards. Authorized users need to check and maintain all conflict of interest and financial interest disclosures that may compromise professional judgment in carrying out research work. Note: FCOI is more applicable to the campuses; the RF has a Corporate Conflict of Interest program outside of pre-award processes.

The IRB (Institutional Review Board) allows campuses to electronically submit, review and monitor IRB protocols. This also allows the human subjects protocol and the grant proposal to be linked, making the information easily accessible to the research compliance and sponsored programs offices, enabling their mutual reviews to be collaborative and efficient.

The IACUC (Institutional Animal Care and Use Committee) Protocol allows departmental administrators and investigators to develop complete protocols and electronically route them for IACUC review.

Export Controls consists of federal laws that require standards to be met which may include federal agency approval before the export of designated or controlled items, commodities, technology, software, or intellectual property can occur to restricted foreign countries, persons, or other entities, such as universities.

Responsible Conduct of Research includes most of the professional activities that are included in a PI’s research work to assure that the practice of scientific investigation is done with integrity. The campus determines the components of its responsible conduct in research program based on the types of research programs conducted at the institution. The program can include, but is not limited to: protection of human subjects and protection of animal subjects.

The Institutional Biosafety Committee allows campuses to electronically submit, review and monitor the biosafety committee protocols, track required training, provide links to guidance and regulations, create questionnaires, and the ability to add additional committees and processing/routing.

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The Radiation Safety Committee allows campuses to electronically submit, review and monitor the radiation committee protocols, track required training, provide links to guidance and regulations, create questionnaires, and the ability to add additional committees and processing/routing.

Campuses use a variety of tools to track regulatory research compliance data, including: The existing system to the extent available in implemented modules. IRBNet Microsoft Excel COI – Smart Paper InfoEd Microsoft Access COI Risk Manager (Osprey) PDF/Smart Forms E-mail CITI Training Homegrown databases

C. Post-Award Management

The RF uses the Oracle E-Business suite as its Enterprise Resource Planning (ERP) system for post award management activities. All campus locations use the Oracle business system to enter transactions, run reports, complete reports and analyze data. The RF’s ERP is grants-centric so that all transactions done in the system have the award, project, and task information embedded in them.

The RF uses these Oracle modules: Human Resources (HR) Labor Distribution (LD) Accounts Payable (AP) General Ledger (GL) Accounts Receivable (AR) Grants Accounting (GA)

In addition, the RF uses these third-party tools in conjunction with Oracle:

Kbace for in-depth reporting and analysis for HR/payroll transactions. GL Wand for general ledger analysis with the capability to drill into the other modules. EiS for entering hourly and overtime information for the calculation of the biweekly payroll. ECRT for effort reporting.

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D. Enterprise Reporting

Summary

The RF uses a reporting application called the RF Report Center that was built using Oracle Business Intelligence Enterprise Edition (OBIEE). The RF Report Center provides an analytical tool that allows campuses to view integrated information from the RF business system.

The tool provides data through interactive dashboards and an ad hoc analysis reporting tool. The RF offers two dashboards—the PI dashboard and the RF Activity Interface Reporting dashboard—to help users quickly and easily find data.

The RF Report Center consists of 28 subjects that provide data for both pre-award and post award management and is refreshed on a nightly basis. The data is primarily from the Oracle E-Business Suite but some data is sourced from the RF’s existing pre-award and regulatory research compliance system and other minor systems.

RF Data Warehouse Architecture

Extract Transform and Load (ETL) processing o Informatica 9.l Mapping and Data Extraction toolseto Oracle Database 11.2 G, PL/SQLo Appworx process flow and job schedulero Daily processing-- Net Change of Data or Incremental change—from midnight to 4 a.m.

Database Environmento Primarily Oracle 11.2 G for EBS Source Datao Oracle 11.2G for ETL/Data Warehouse Database

Business Intelligence Software and Environmento Oracle Business Intelligence Enterprise Edition Suite 11.1.1.7o Dashboards, Ad hoc Queries, BI Publisher, BI Map View, Score Cardso Scheduled Reports and Queries

Serverso Primarily an IBM LPAR 770 Virtual Unix environment running AIX 6.1

Availability

The RF Report Center and data warehouse are available 18-20 hours per day. ETL processing occurs daily-- net change of data or incremental change—from midnight to 4 a.m. Monday through Friday.

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