The Johns Hopkins University School of Medicine Office

The Johns Hopkins University School of Medicine Office of Research Administration Outgoing Subawards Bootcamp Training Sept 2017 1

Our Work is Divided into Two Categories… Drafting, execution, and termination of outgoing subgrants and subcontracts Purchase order creation, management, and termination 2

When is an Outgoing Subaward Necessary? A subgrant or subcontract is necessary when: The site will perform work which satisfies a direct objective or deliverable of the Prime Award The site will be responsible for programmatic decisions or design The site will be held accountable to the compliance regulations or seek to publish/co author the study results The site will use the Prime Award funds to carry out its own programmatic work The site provides cost sharing or has key personnel mentioned in the Notice of Grant Award (NGA) 3

Other Types of Agreements… (Not Drafted by Subawards Team) Service/Vendor Agreement (drafted by Purchasing, Purchase Order (PO) set up by dept): Storage (drug, supplies, etc. ) Website design & management for a clinical trial. Draft Examples: http: //ssc. jhmi. edu/supplychain/forms/index. html The federal government calls these sites Contractors Complex Data Use Agreement Complex Material Transfer Agreement Collaboration Agreement 4

Types of Prime Sponsor Funding… Subaward Agreements under Federal and state grants/contracts Foundation grants Commercial contracts Subaward Agreements with funding from multiple sources Please try to make us aware of all the sources of funding (commercial and non-commercial) for the Subaward Agreements under internal JHU awards (800 accounts) or master affiliate agreements 5

Internal JHU Funding & Other Special Situations… INTERNAL NTAP – Neurofibromatosis Therapeutic Acceleration Program PACKARD – The Robert Packard Center for ALS Research CONSORTIUMS WITH MASTER AGTS TBCRC – Translational Breast Cancer Consortium ABTC – Adult Brain Tumor Consortium IMPAACT – International Maternal Pediatric Adolescent AIDS Clinical Trials AFFILIATES CRN – Clinical Research Network (AAHSRI, INOVA, PRMC, RHMC, AHN) ACRI– All Children’s Research Institute KKI – Kennedy Krieger Institute JHHG/JHHCG CAPRES – Capital Region Research 6

SOM ORA Subawards Process Chart… Subaward Paperwork ORASUBCONTRACTS@jhmi. edu receives notice of prime award set up with Subawards under it ORASUBCONTRACTS emails COEUS PD dept contact to request prime award specific Department sends back ALL requested paperwork and file is assigned to Subs Team Member (STM) Subaward Preparation STM evaluates paperwork and information, STM requests additional information from dept if necessary and drafts agreement STM requests vendor number (if necessary), 96 IO, and Shopping Cart for Purchase Order STM submits draft for internal review and corrects draft accordingly Subaward Negotiation STM sends draft to subsite for review and negotiation Subsite returns revisions for STM approval STM (supervisor) approves/rejects revisions, emails site with explanation/clean draft (repeat until draft is satisfactory to both parties) Subaward Execution STM receives signed copy from subsite partially executed (PE) and adds PO number to original agreements or money to PO for modification agreements STM submits PE to supervisor for signature; supervisor reviews, signs and dates agreement (FE) ORASUBCONTRACTS sends fully executed (FE) to dept & subsite separately with invoice instructions and closes file 7

Subaward Paperwork ORASUBCONTRACTS@jhmi. edu receives notice of prime award set up with Subawards under it ORASUBCONTRACTS emails COEUS PD dept contact to request prime award specific paperwork Department sends back ALL requested paperwork and file is assigned to Subs Team Member (STM) 8

Subaward Paperwork ORASUBCONTRACTS@jhmi. edu receives notice that the prime award has been set up and there are Subawards indicated 9

Subaward Paperwork ORASUBCONTRACTS sends an email to the department contact indicated on the COEUS PD to request paperwork 10

Subaward Paperwork The paperwork requested is specific to the type of Prime Award: Federal, Commercial, Foundation. 11

Subaward Paperwork Department contact sends back ALL requested paperwork. Paperwork is saved & file is assigned to a Subs Team Member (STM). 12

Subaward Paperwork All paperwork submitted is saved to our share drive. 13

Subaward Paperwork A Log entry is created in our database for tracking. 14

Subaward Paperwork An internal email is created and sent to the assigned Sub Team Member (STM) letting them know that the file is setup and ready for drafting. 15

Subaward Preparation Subs Team Member (STM) evaluates paperwork and information, STM requests additional information from dept if necessary and drafts agreement STM requests vendor number (if necessary), 96 IO, and Shopping Cart for Purchase Order STM submits draft for internal review and corrects draft accordingly 16

Subaward Preparation 17

Subaward Preparation For originals: A Subrecipient Determination Form (SDF) A Subaward Information Sheet A budget for the subsite F&A and Fringe Rate Agreements (Federal Prime, Cost Reimbursement Only) A statement of work for the subsite IRB/IACUC approval for the subsite (if applicable) Wire transfer agreements for subsites in foreign countries Conflict of Interest Documentation (SFI) (Federal Prime) (if applicable) And for new sites…Subrecipient Questionnaire For modifications: A Subaward Information Sheet A budget for the subsite (not for no cost extension (NCE) or carry over alone) F&A and Fringe Rate Agreements (Federal Prime) A statement of work (only if it has changed significantly) Updated IRB/IACUC approval (if applicable) Conflict of Interest Documentation (SFI) (Federal Prime) (if applicable) 18

Special Considerations for Subsites Under Federal Funds… Under Federal grants and contracts, all Subrecipients should be registered in the System for Award Management (“SAM”) [high risk sites], and must have a DUNS number SAM website: https: //sam. gov DUNS number requests: http: //fedgov/dnd. com/webform 19

Special Considerations for Subsites Under Federal Funds… High Risk Subrecipient Monitoring: ORASUBCONTRACTS will provide the JHU (https: //apps. finance. jhu. edu/depts/frc/sub_risk_rating. html) and the Federal Demonstration Partnership (FDP) (https: //fdpclearinghouse. org/) link to dept who will identify sites that need to complete a Subrecipient Questionnaire The Dept will send the Welcome Packet and Questionnaire to the identified sites and return it to ORASUBCONTRACTS Office of Research Administration (ORA) Subawards Group rates the sites and notifies the dept and to Financial Research Compliance (FRC) who confirms the rating and performs subsite audits FRC reviews the ratings periodically and may change a site’s rating; check the rating list prior to invoice processing The dept can request a review by FRC to increase or decrease a rating High Risk Subrecipients must submit invoices on the template included as an exhibit to the cost reimbursement Sub Agreement (unless they have a similar template). The JHU dept must complete additional invoice audits per the FRC regulations which took effect on 7/1/14. FRC is available to assist in the invoice audits and determination of sufficiency of back up paperwork required for the audit. 20

Conflict of Interest Under Federal Funds… As of 8/24/12: Subsites are required to submit Conflict of Interest (COI) information at the time of JHU application to the JHU Grants Associates if they are not registered in the Federal Demonstration Partnership (FDP) Clearinghouse. http: //sites. nationalacademies. org/PGA/fdp/PGA_070596 If the site is not registered in the FDP Clearinghouse, Subs team will request that the dept get an SFI from the Subsite prior to submission of Subaward documents to ORASUBCONTRACTS. 2 Options: Complete, and certify best ability at time of JHU application Opt to complete certification at time of Subagreement award Subs team will choose appropriate COI language for the Agreement 21

Subaward Preparation: SDF 22

Subaward Preparation: Infosheet 23

Subaward Preparation: Infosheet 24

Subaward Preparation: Infosheet Always provide all information, even if it seems like common sense knowledge (i. e. providing your building’s exact address, zip code, etc. ) Include credentials for JHU PI (i. e. MD, Ph. D). Be sure to list all JHU persons who should be copied when the Subaward is emailed to the Subsite. 25

Subaward Preparation: Infosheet Provide the subsite’s legal name, not their commonly used name. Provide the Subsite PI/Project Director’s credentials (i. e. MD, Ph. D). The ORA contact address can’t be a PO Box 26

Subaward Preparation: Infosheet The first 3 items can typically be found in the Prime Award. The last 3 items are JHU-specific. When providing the Prime Award Current Budget Period, please note that a) this is a date range, not a monetary amount, and b) this refers to the budget period of the Project/Study as referenced in the current Prime Award under which the Subagreement is funded. 27

Subaward Preparation: Infosheet Subsite budget period dates must be within the Prime Award current budget period dates. The budget total should include only direct and indirect costs for this iteration of the Subaward. Federal Prime: Provide the Subrecipient’s Indirect Cost Rate (IDC) Rate Agreement. If the Subrecipient IDC rate is less than 10% (domestic) or 8% (foreign), please provide documentation showing that the Site declined to receive minimum amount. Federal Prime: Provide the Subrecipient’s Fringe Rate Agreement (FRA). If the subsite does not have an FRA, provide documentation of rate calculation and dept verification of reasonableness. 28

Subaward Preparation: Infosheet Answer YES if a) carryover approval is required under the Prime Award (check the Original Subaward if you’re unsure), and b) the Subrecipient has unspent funds from previous years that you want them to be able to spend in the current Budget Period. Please check your PO# to confirm the carryover amounts you provide. 29

Subaward Preparation: Carry Over Office of Research Administration’s (ORA) default position on carry over - subs follow the terms of the prime grant or contract However, even in cases where the prime grant/contract allows for automatic carryover, the department and Principal Investigator (PI) may request ORA to set up subs so that the subsite must obtain authorization to carry over any funding. In order for funding to be carried over under Federal funding, the balance should be reported on the Financial Status Report as an “unliquidated obligation. ” ORA will require verification from Sponsor that the carryover has been approved. If the prime award is from a foundation, the carryover process should comply with award guidelines about how much money can be carried over, etc. 30

Subaward Preparation: Infosheet If human subjects or vertebrate animals are involved, please send us the Subrecipient’s IRB/IACUC approval (use JHU’s approval for Kennedy Krieger Institute (KKI)/Clinical Research Network (CRN). 31

Subaward Preparation: Infosheet Deliverables Chart required for all Original subawards, and for any modifications under which the Scope of Work (SOW) is revised. Please list all tangible deliverables. If there are none, list something like conference calls. 32

Subaward Preparation: Infosheet The Reports Table isn’t required. If it isn’t completed, we will include standard reporting requirements language. Invoices do not need to be listed as a financial report; they are addressed elsewhere in the Subaward. 33

Subaward Preparation: Infosheet 34

Subaward Preparation: Infosheet If you are working with patients but are not paying them a perpatient (or per-sample, etc. ) fee, you will be required to pay them for the work they do regardless of whether they meet their recruitment goals. A per-patient fixed price budget should be provided. This can be a simple Word document that lists the costs that make up the total per-patient fee. If you are paying the Subrecipient for partial completion, please provide the details: how much they will be paid and what they need to accomplish in order to be paid that amount. 35

Subaward Preparation: Infosheet If a study drug is being supplied to the Subrecipient, we will need to draft a separate agreement to cover the study drug. The Subaward won’t be able to be drafted until the Pharma Agreement is fully executed. 36

Subaward Preparation: Infosheet If physical materials are involved and they were not generated/invented/created as a result of this study/project, we will need to draft a Materials Transfer Agreement with the Subsite. This will be drafted by a) us (the MTA cannot be negotiated), b) Tech Ventures (the MTA can be negotiated), or c) the Subsite (only if the materials are being sent from the subsite, to JHU; the MTA can be negotiated). If the Subsite is paying for disposal/return of the materials, please make sure these costs are reflected in their budget. 37

Subaward Preparation: Infosheet If equipment is being “supplied/sent” to the Subsite, and the Subsite is buying it with the funding we supply, make sure it is listed on the budget. 38

Subaward Preparation: Infosheet EPIC data is treated differently than other human subjects data and requires separate approval documentation. 39

Subaward Preparation: Infosheet Have the JHU Principal Investigator review and sign the Information Sheet before submitting. This page can be submitted as a separate PDF document. 40

Subaward Preparation: Budgets Cost Reimbursement budgets for subs under Federal grants should include: Names of personnel Breakdown of costs for equipment, supplies, and “other expenses” Explanation of travel costs Fixed Fee budgets: if the site is going to be paid for each patient it accrues, or for each sample it obtains, etc. , the budget must indicate the number of patients/samples and the amount that will be paid for each one. Consider whether the costs are allowed under the terms of the award/contract. 41

Subaward Preparation: Budgets 42

Subaward Preparation: Budgets 43

Subaward Preparation: Scope of Work (SOW) Alternately known as a “work scope”, the SOW is a short paragraph describing what the Subsite is doing. The SOW should NOT be a summary of the whole grant. The SOW should also state what the subsite is going to provide to JHU in exchange for being paid (“deliverables”). Examples include patient data from clinical trials, blood samples, tissue samples, assays, scans, and analysis of samples, or even reports/publications and conference calls to discuss results. Deliverables can be tied to payment (Fixed fee budgets: the site will be paid $10, 000 for every five patients it enrolls) SOW should be understandable to non-scientists. The SOW is used in a dispute to determine whether the site is performing in accordance with the agreement, so be clear and specific. The Deliverables table will be part of the SOW and subaward and should include concrete due dates/time lines. 44

Subaward Preparation: SOW 45

Subaward Preparation: 96# The 96 # simply refers to the SAP account number for the sub. The 96 # will be set up with the sub amount, plus whatever Indirect Cost (IDC) JHU is entitled to take. Generally speaking, the IDC rate for the 96 # must match the IDC rate for the IO # it is based upon, although there may be some (limited) exceptions. After the first year of the Subaward, the departments are responsible for distributing money to the 96 #. SAP Role: GM_Budget_Create Gift accounts (800) do not receive 96 #s. 46

Subcontracts and Indirect Costs… Under Federal subs…Modified Total Direct Costs (MTDC) For subs under federal grants and contracts, JHU takes additional Indirect Cost (IDC) on the first $25 K of the subcontract budget. For every original subaward agreement drafted JHU IDC is requested regardless of multiple projects or PI’s at the subsite Under non-Federal agreements…Total Direct Costs (TDC) Generally, under foundation awards and commercial contracts, the same IDC rate is applied to both the JHU and the subsite budget. For foundation awards, the subs team gets the IDC information from the Grants Associate who completed the application When setting up 96 numbers for subs under commercial agreements with fixed fee budgets, JHU does NOT charge any additional IDC against the 96#; For commercial clinical trials a “receipt tax” is charged at the time the money is paid to JHU. When setting up 96 numbers for subs under commercial agreements with cost reimbursement budgets, JHU does charge additional IDC against the 96# per the prime award budget/terms; 47

Subaward Preparation: 96 request 48

Subaward Preparation: 96 request 49

Subaward Preparation: Purchace Order (PO) Once Sponsored Projects Shared Services (SPSS) provides the created 96 #, a Shopping Cart is created. The created Shopping Cart generates a Purchase Order number (PO) and establishes the first line of the PO. �Fixed Price/fee shopping carts are set up for 1 patient or start up/costs or invoice-able fees �Carryover/reduction agreements do not reflect on the PO �When the final invoice is submitted, send request to close PO to ORASUBCONTRACTS@jhmi. edu. (Termination Agreement needed if budget period is still valid) 50

Subaward Preparation: Purchase Order (PO) 51

Subaward Preparation: Purchase Order (PO) �Creation: PO is created when the contract is created �Modification: Time and/or money added when sub is modified. �Close-out: PO is closed per department request when project period of grant/contract ends, or sub is terminated early. If money is left on 96#, the close out process will unencumber it. **Do NOT have Purchasing or SAP help do these things!** 52

Subaward Preparation: Agreement The Subagreement is drafted in tandem with the 96 # request. It is drafted on either a JHU Template or an Federal Demonstration Partnership (FDP) Template. When to draft on JHU template: �The subsite is High Risk and/or a foreign institution �There are multiple projects under the same site �An Material Transfer Agreement (MTA), Data Use Agreement (DUA), Equipment Transfer Agreement is necessary �The budget is Fixed Fee/Per Patient/Per Milestone �The Sponsor is not NIH, NSF, USDA, EPA, NASA, AFOSR, ARO, ONR, AMRMC, AMRAA 53

Subaward Preparation: Agreement Who Prepares What? Director: Original subcontracts under federal and Subcontracts under commercial contracts (to include commercial terms for sites funded by other grantors) CRN SSA’s, NTAP, TBCRC, 800 accounts Senior Associate: Subs under state grants & contracts/foundation awards Modifications of subcontracts under federal contracts TEDCO, PCORI Associate: Subs under foundation awards/federal grants Modifications as assigned by Director 54

Subaward Preparation: Agreement Intellectual Property Payment Information Indemnifica -tion Technical and Financial Reporting What’s in a Sub Agreement? ? Certifications to the Grantor or Sponsor Contact Information Period of Confidentiality Termination Adverse Event Reporting Performance 55

Subaward Negotiation Sub Team Member (STM) sends draft to subsite for review and negotiation Subsite returns revisions for STM approval STM (supervisor) approves/rejects revisions, emails site with explanation/clean draft (repeat until draft is satisfactory to both parties) 56

Subaward Negotiation Draft is sent to the subsite for review and negotiation Subsite returns revisions (redlines) for approval Revisions approved/rejected Email sent to site with explanation/clean draft (repeated until draft is satisfactory to both parties) 57

Subaward Execution Sub Team Member (STM) receives signed copy from subsite (partially executed (PE)) and adds PO number to original agreements or money to PO for modification agreements STM submits PE to supervisor for signature; supervisor reviews, signs and dates agreement (fully executed (FE)) ORASUBCONTRACTS sends FE to dept & subsite separately with invoice instructions and closes file 58

Subaward Execution Site returns a signed copy of the agreement (partially executed (PE)) Sub Team Member (STM) confirms receipt of Federal Demonstration Partnership (FDP) 3 B attachment and IRB/IACUC approval, if applicable Database file is updated Purchase Order is updated Originals – Purchase Order number is added to the partially executed (PE) Modifications - Update Purchase Order PE is sent to supervisor for signature Supervisor reviews, signs and dates agreement (fully executed (FE)) FE sent by ORASubcontracts@jhmi. edu to department; Separate FE email sent to subsite **Everyone named on infosheet will receive FE** 59

Subaward Execution 60

Subaward Execution 61

Post Execution: Purchase Order (PO) Close Out Office of Research Administration (ORA) closes the Purchase Order per a dept request once the final invoice is approved, submitted to Accounts Payable (AP), confirmed and paid. If the period of performance for the subaward has expired, the department sends the ORA Subawards Team (ORASUBCONTRACTS@jhmi. edu) an email with the PO number and indicating that it should be closed. PLEASE DO NOT EMAIL PURCHASING/AP/SPSS/SAP/PO MAINTENANCE FIRST! The Subawards Team does not move money off of or unencumber money from the 96. If this does not automatically happen when the PO closes, please reach out to Purchasing@jhu. edu or SAPHelp@jhu. edu for more help. 62

Post Execution: Purchase Order (PO) Close Out There are several situations where a Subaward Purchase Order (PO) might need to be closed out before the period of performance expires. If the period of performance has not expired AND a final invoice has been paid: The department should send an infosheet to ORASUBCONTRACTS On the infosheet the period of performance should start on the date of their last agreement and end on the final invoiceable date On the infosheet the amount should be the total amount paid for that period of performance ORA will send the site a termination modification AND close out the Purchase Order (PO)/Shopping Cart (SC) once the mod is fully executed The period of performance has not expired AND a final invoice has not been paid: The department should send an infosheet to ORASUBCONTRACTS On the infosheet the period of performance should start on the date of their last agreement and end on the last date the sub PI completed work for JHU ORA will send the site a termination modification The department should email ORASUBCONTRACTS when the final invoice is paid ORA will close out the Purchase Order (PO)/Shopping Cart (SC) at that time 63

Post Execution: Purchase Order (PO) Close Out � If the subsite Principal Investigator is moving to another subsite and will still conduct work for JHU under the project The department should request paperwork from ORASUBCONTRACTS for a new subsite The department should complete and return the paperwork to ORASUBCONTRACTS Office of Research Administration (ORA) will draft and submit the new sub AND create new 96/Purchase Order (PO) no additional indirect cost (IDC) charged � If the subsite is appointing another sub-PI to do the work at their Institution The department should send an infosheet to ORASUBCONTRACTS with the new PI’s information on it and a new budget for that PI for the remaining portion of the current grant year ORA will modify the current agreement with the subsite The existing 96/PO will continue to be used 64

What the Departments do in relation to purchase orders: • Add money to the 96 each year/per patient invoice • Process and pay invoices • Complete goods receipts • Ensure consistency with Real Time Grant Report and other SAP reports 65

Invoice Process… Per the terms of our contracts, subsites should send invoices to the department financial contact on the sub information sheet. If Office of Research Administration (ORA) Subawards Team receives an invoice erroneously, it will be forwarded to the Financial Contact for the sub. Payment of invoices beyond the end of allowed period indicated in the Subagreement is discouraged. Contact ORASUBCONTRACTS if you have questions about this. Confirm with the Principal Investigator that the work has been performed and that any necessary reports have been submitted. Principal Investigator should be aware of payments. Partial payment is allowed if all deliverables are not met or if there is a dispute over other charges. Certification for Payment form should be completed for all invoices (regardless of the Sponsor or Subsite risk rating), and signed by the JHU Principal Investigator. Departmental contact sends invoice and Certification to Accounts Payable via POExceptions@jhmi. edu. Make sure to keep a copy. The e-mail should indicate if the invoice should be split between lines on the purchase order and how much to put on each line. For Fixed Fee/Per Patient budgets, dept should send an email to ORASUBSUBCONTRACTS asking for money to be added to the Purchase Order BEFORE submission of the invoice to Accounts Payable. 66

Invoice Review: Standard Items… Name of the subrecipient JHU purchase order number Date of the invoice Invoice number and project title Period of performance covered by the invoice Breakdown of costs in accordance with expenditure categories Current period costs and cumulative project costs Cost sharing (if applicable) Program income (if generated) Contact person for invoice questions Certification as to the truth and accuracy of the invoice Shouldn’t overlap with previous invoice and should NEVER exceed the termination date. Foreign sites: include wire account # YOU CAN ‘WRITE’ IN ANY MISSING ITEMS ON AN INVOICE BEFORE YOU SUBMIT IT TO ACCOUNTS PAYABLE!! 67

Goods Receipts… Goods Receipts (GR) are confirmations that goods or services have been received. A Goods Receipt must be completed for each invoice that is submitted to Accounts Payable (AP) for payment. Goods Receipts facilitate the “Three Way Match”, which means that the Purchase Order, the Goods Receipt, and the vendor invoice all show the same price and quantity. A GR request is sent to the ORA STM’s ECC inbox, who forwards it to the ECC inbox of the appropriate departmental contact. The Sr. Subawards Associate is able to reverse GR’s that were done through the ECC inbox. The dept is able to reverse GR’s that were done through Central Receiving. We prefer GRs to be completed via Central Receiving. (Central Receiving SAP Role: ZESC_SC_RCV_CNT_All) SAP manuals available at: http: //ssc. jhmi. edu/supplychain/training 68

Its taking too long! Can I pay the Subsite without the signed Subaward? Complicating factors in completing a sub: Subsite wants indemnification from sponsor Subsite has not obtained IRB approval Sponsor has to approve something- like the replacement of a project director. Payment/Purchase Order issues �Please do NOT: Make payments to subsites via online check requests Provide subsites with purchase order numbers before original contracts are fully-executed. Create goods receipts before the invoice has been posted in SAP. 69

Troubleshooting… �Generally speaking, the Subs group cannot resolve Enterprise and Real Time Grant Report issues (incorrect encumbrances, etc. ). �We only close the Purchase Order and reverse Good Receipt's, which should correct encumbrance issues. �For remaining encumbrance issues contact Purchasing (http: //finance. jhu. edu/depts/procurement/about/purc h_mission. html) or Sponsored Project Shared Services (http: //ssc. jhmi. edu/sponsoredprojects/index. html) accordingly. We can direct you to the correct group. �For invoice issues contact Accounts Payable (http: //ssc. jhmi. edu/accountspayable/po. html) 70

In General… If you have questions about what you need to submit or something the subsite is asking for, please call or e-mail us. Vacant Assistant Director 410 -361 -8352 Michelle Sloan, M. H. A. Sr. Subawards Associate 410 -361 -8367 msloan 7@jhmi. edu Rhanota Edwards, M. S. Sr. Subawards Associate 410 -361 -8371 redwar 20@jhmi. edu Subawards Associate 410 -361 -8356 pstuart 1@jhmi. edu Subawards Specialist 410 -361 -8341 orasubcontracts@jhmi. edu Paul Stuart, B. S. Patrick Sears, B. A. 71