Sponsored Projects Training: Submitting Contracts & Other Research Agreements to ORA

Transcription

1 The Johns Hopkins University School of Medicine Office of Research Administration Sponsored Projects Training: Submitting Contracts & Other Research Agreements to ORA March/April 2013

2 We perform our work as a team: SPECIALISTS receive and pre-review contracts, proposals and other research agreements from commercial and federal sponsors. They collect required signatures and prepare the awards for workflow to Sponsored Projects Shared Services. DIRECTORS continue the review, negotiate and ultimately approve the contracts/ agreements. The Directors and Associate Dean for Research execute (sign) the agreements. 2

3 Types of agreements processed by Specialists and Directors at ORA (MRB) Funded Agreements Contracts & Subcontracts Commercial Grants & Subgrants Complex Federal Grants Non-Commercial Clinical Trials Non-profit Sponsored Contracts Non-Monetary Agreements Confidentiality Non- Disclosure Agreements (CDA or NDA) Data Use Agreements Collaborations Memorandum of Understanding (MOU) Equipment/Software Loan Agreement 3

4 1. Specialist receives COEUS PD in ORA mailbox, per Assigned Department 2. Specialist reviews COEUS PD Summary for accuracy and completion; performs initial review (pre-review) for the Required 6-Pack info 3. Specialist creates a MyRAP record; continues pre-review Approves the COEUS PD, except for grants 7. Specialist is identified as new owner; circulates agreement for required signatures 6. Director conducts review, evaluates content, negotiates the agreement, transfers ownership of folder 5. Ownership of Folder and MyRAP record transfer to a Director 4. Specialist starts a Folder : Agreement PD Summary IRB/IACUC 8. Specialist uploads fully executed agreement to MyRAP and processes the records for scanning to Oculus 9. Specialist transfers MyRAP ownership to ORA Operations Analyst, who completes the record when the documents have been scanned to Oculus 10. ORA Operations Analyst workflows funded agreements to SPSS via Oculus 4

5 Who do I contact in ORA? The Department Assignments for the Miller Research Building (MRB) Sponsored Projects Specialists are posted on the ORA website: However, one Specialist may be assigned to a particular Sponsor because of the volume of agreements, funded by that Sponsor, all across the School of Medicine. The MRB ORA Specialists are: Jenifer DeLeaver Mary Deloatch Celeste Hartman Angela Mellerson 5

6 How do we determine priorities? Hard sponsored deadlines in COEUS are noted and confirmed. If there is no hard deadline, please leave the field BLANK on the PD Grants and Contracts w/ hard deadlines are processed first; then CDA s and Data Use Agreements Urgent proposals, as noted on the Supplemental Information for Commercial Agreements form All others are processed in the order received 6

7 What information is necessary? 6-Pack For an initial or original agreement: Supplemental Information form Editable version of the Agreement (preferably in Word) Budget, when applicable Statement of work IRB/IACUC approval COEUS PD, with all documents uploaded For amendments: Supplemental Information form Editable version of the Amendment Budget Statement of work (but only if it has changed) Updated IRB/IACUC approval A COEUS PD incl Master Proposal #, with all documents uploaded 7

8 Who obtains the information? Departmental contacts are responsible for obtaining the required information for all contracts, agreements, and complex grants. ORA can help with the process by clarifying what is necessary, but we cannot get these materials for you. For commercial sponsors, there is a required Supplemental Information for Commercial Agreements form which must be completed and uploaded in order for your proposal to be reviewed. Please note that although information about the proposal was submitted with the application/coeus PD, the department must obtain all follow-up information requested by ORA staff to assure that the proposal continues to move through the process as quickly as possible. While most information is electronic, if you are delivering any related paper (hard copy) materials to ORA, please make sure that you indicate PD # on the envelope or folder. 8

9 Preparing Your 6-Pack for Commercial Agreements For an initial or original agreement: Supplemental Information for Commercial Agreements form website: Editable version of the Agreement (preferably in Word) Budget, when applicable Statement of work IRB/IACUC approval COEUS PD, with all documents uploaded For amendments: Supplemental Information for Commercial Agreements form Editable version of the Amendment Budget Statement of work (but only if it has changed) Updated IRB/IACUC approval A COEUS PD incl Master Proposal #, with all documents uploaded The most important areas to complete on the Supplemental Information form are isolated and displayed on the next 3 slides. Remember to upload the completed form to your COEUS PD. 9

10 Supplemental Information for Commercial Agreements PI: SPONSOR: PROJECT TITLE: I. Type of Study: (CHECK ONLY ONE) Clinical Research Defined as: All commercial clinical research that involves patients or PHI, or clinical testing or procedures, or drug/device diagnostic testing in humans or any planning/lab/clinical service in support of such clinical research. Please send directly to Clinical Research Contracting, 1629 Thames Street, Suite 200, Baltimore, MD or Other Research (anything other than clinical research as defined above) Includes (Check ALL that apply) Materials provided by sponsor or other (with a commitment to conduct specific research) Funding by sponsor or other Equipment provided by sponsor or otherother collaborations Other (e.g., services, lab analysis, etc.)please specify 10

11 Supplemental Information for Commercial Agreements II. Documents (REQUIRED) for Review of Agreements A. Contract documents (items a-c) a. Copy of proposed contract paper and/or electronic (preferred) b. Statement of work (protocol abstract, description) c. Other relevant documents (e.g. invention disclosure, investigator agreement, etc) B. Sponsor contact information for contract negotiation a copy of correspondence or is acceptable. Name Fax Phone Address 11

12 Supplemental Information for Commercial Agreements VI. Priority (select A or B below) A. Urgent -- The following are eligible for urgent review: compassionate use, limited site selection, capped accrual, or other emergent need. To be eligible for urgent review, an explanation of the reason for urgent review MUST be provided below. Without an explanation the agreement will be treated as Routine. (EXPLAIN): Note: Protocol must be submitted to the IRB before or simultaneously with ORA receipt of contract to be considered Priority A and eligible for urgent review. Please provide a copy of the submission (minimally the first page of the form). (ORA initial review within five business days) B. Routine -- All other corporate agreements, investigator initiated clinical trials, basic research agreements. (ORA initial review within ten business days) 12 C. Master or Model Agreements - - Studies that are being done under a Master Agreement, Model Agreement, or where the company has used a JHU template.

13 Information necessary to fill out the COEUS PD Summary Principal Investigator and Co-Investigators Responsible Cost Center number Sponsor Type of Proposal Sponsor grant/contract number, if known Master IPN, if not a new proposal Animal and/or human subjects protocol approvals, if applicable Period of performance dates Amount of the award request, if applicable 13

14 Budgets In all budgets, consider whether the costs are allowed by JHU and the Sponsor. Specifically, costs must be reasonable/necessary, allocable, consistently applied, and in conformance with JHU policy and the terms of the award. Consider whether the costs are allowed under the terms of the RFA or RFP Determine the appropriate Facilities and Administration (F&A) rates, also known as IDC rates. Refer to the following website for current rates: 14

15 Statement of Work Also known as a work scope, the SOW describes what the JHU PI or staff will do. The SOW is not always a summary of the whole proposal. Based on the statement of work, you and the ORA reviewers should be able to determine whether the budget is appropriate. 15

16 IRB and IACUC approvals Please be aware that ORA can review a proposal without current IRB or IACUC approval, but we must have the approval in order to fully execute the contract for account set-up. 16

17 Budget and Payment Information Intellectual Property Technical and Financial Reporting Subject Protection Indemnification What s in a contract? Contact Information Confidentiality Period of Performance Termination Statement of Work 17

18 Things to be aware of 18 If the proposal has a direct commercial sponsor or 3 rd party commercial sponsor AND is clinical research, then it will be processed at Fells Point. If the project has a commercial sponsor BUT the funding is from a federal sponsor, then it will be processed at the MRB. (e.g. SBIR) The PI and each Co-Investigator on the project needs to be listed as a team member on the IRB and/or IACUC approved protocols. Please be very careful when using copy paste features from a prior submission to complete subsequent documents. It is easy to submit documents with outdated information if this is done too quickly and not carefully proof-read. Please read your documents and update ALL information, as needed. The PI must be registered in MyRAP. Go to this link to login and register your MyRAP account:

19 Why is it taking so long?? Can t I just get my SAP update now?? Complicating factors that can delay a fully executed agreement: Negotiation issues w/ contract terms (e.g. Intellectual property) PI has not obtained IRB or IACUC approval Delays in Resubmission of corrected COEUS PD Communication gaps: Please cc Specialist on any follow-up information being provided to the Director Negotiator requires more information from Sponsor or PI Incorrect contact information for the Sponsor Late or no response when Partial Ex is sent to PI or Sponsor for signatures 19

20 So now we have a fully executed agreement, but what s next?? Preparing the File for SPSS Workflow What Specialists do to get you closer to an SAP Update: Purge: Specialists shred paperwork no longer needed to document an official agreement Upload Document to ORA Shared Drive & MyRAP: A complete record of the fully executed agreement and supporting documents is stored on ORA s server Fully executed agreement is uploaded to MyRAP Transfer File to ORA Operations Analyst for Final Review and Scanning: To Oculus To SPSS (via Oculus) for funded agreements 20

21 Please do NOT: - Submit a proposal directly to a Sponsor WITHOUT routing it thru ORA - Provide incomplete protocol approvals - Begin your project before both the ORA and Sponsor have executed the agreement. Only a fully executed agreement is recognized as authorization to begin the work. 21

22 What Departments can do to help us: Provide requested information in a timely manner Send complete documents Ensure consistency in documentation and accuracy when referencing COEUS PD, MyRAP, PI s, Project titles, etc. in communications Be kind and patient 22

23 Contact the Specialists If you have questions about what you need to submit, please call or us. Jenifer DeLeaver Mary Deloatch Celeste Hartman Angela Mellerson

24 Other team members Dezire Chaney, Sponsored Projects Asst Rhanota Edwards, Operations Analyst Rosalind Palmer, Sponsored Agreements Mgr Office of Research Administration Suite 117, Miller Research Bldg 733 N. Broadway Baltimore, MD