The RASP Advisor A Weill Cornell Medical College Research Community Resource

Transcription

1 The Research and Sponsored Programs Advisor Volume 3, Issue 5 Available for download at The RASP Advisor A Weill Cornell Medical College Research Community Resource Research Administrative Information System Enhancements (RAISE) WCMC s current IT systems landscape includes approximately 40 disparate modules within systems like Coeus, SAP, ERF, GECB, EPIC, etc. and other non-system electronic forms like the Human Research Billing Administration Form (HRBAF) and other tracking spreadsheets. These are managed by many offices within research administration, including but not limited to Research And Sponsored Programs (RASP), Finance/Research Accounting, Office of Billing Compliance (OBC), the Physician Organization (PO), the Clinical Translational Science Center (CTSC). Many opportunities exist in working together to minimize redundancy in the technology used to manage research. A steering committee was formed and charged the staff of the initiative to execute on an initial set of deliverables. The first, eirb, a web-based system to submit and track IRB submissions is scheduled to go-live at the end of June. Another focus of RAISE is Research Visibility, leveraging data in the existing systems to create reports and dashboards for individual PIs and department administrators. A bit farther down the pipeline is Proposal Development, a grants submission system with a direct interface to grants.gov. Sending information directly to the government and having multi-system reports and dashboards requires two additional projects under the RAISE initiative. The first has been named datasync to create data quality and entry standards across systems. The second, business process review, to make sure that the processes and best practices are being followed along with any enhancements to the technology used for research. In addition to the steering committee, several workgroups have been and will continue to be established to get expert and end-user feedback throughout the process. We anticipate that many of you will be asked to participate and we welcome your feedback and participation. IRB The Launch of eirb The Office of Research Integrity and Assurance is pleased to announce that the new online IRB submission system, called eirb, will be ready for use by the research community on June 25, In order to transition to eirb, the following changes to the submission procedures, IRB deadline and meeting schedule will be put into place. Feel free to contact me if you have any questions: 1. The IRB meeting scheduled for July 9, 2012 will be cancelled. 2. The deadline for the last IRB meeting before eirb goes live is June 4 th. After June 4 th, no new full board initial submissions or full board amendments will be accepted outside the eirb system. 3. JIRA will continue to accept expedited submissions and full board continuing reviews that will expire before the IRB meeting on July 23 rd IRB until June 13, 2012 (Those full board Continuing reviews will be put on the agenda for the June 25 th meeting). After June 13, 2012, the JIRA listserve will be deactivated. Immediate reports and short form consent approvals should be sent to irb@med.cornell.edu. 4. A member of the IRB staff will be adding limited information for currently active protocols into eirb. Any missing information for these protocols will have to be input the first time you will be submitting either an amendment or continuing review for the protocol, so please allow yourself extra time to prepare the submission. 5. For the meeting to be held on July 23, 2012, all submissions (amendments, continuing reviews and RTQs for already submitted applications as well as new full board applications) must go through eirb. The deadline for submitting to the IRB for this meeting will be extended to July 9, Please notify the sponsors of your protocols of this schedule for the months of June and July. Additional information will be provided at the eirb training sessions. We strongly recommend that anyone involved in human subjects research attend one of these trainings to become familiar with the system and the impact of this new system on the submission process. If you haven t yet registered for one of the training sessions, please go to the following link

2

3 Grants and Contracts Grants & Contracts and Office of Clinical Trials Listservs The Grants & Contracts Office and the Office of Clinical Trials Administration operate a number of Listservs that are monitored by staff members that will be able to assist you. The Listservs allow us to monitor incoming correspondence in case there are any absences to ensure continued service of your needs. The table below summarizes all of our current Listservs, which personnel monitor it and their purpose. The primary contacts are in boldface type. Listserv Personnel Purpose grantsandcontracts@med.cornell.edu Ady, Erica, Hilary, Stephen, Felicia, Jen, Business Official . Serves as point of contact for sponsors to reach WCMC with grant related matters. subawards-wcmc@med.cornell.edu sra@med.cornell.edu materialtransfer@med.cornell.edu octa@med.cornell.edu erf@med.cornell.edu sra_mta_cdas@med.cornell.edu Patricia, Stephen, Ady, Erica, Barbara, Diana, Gina, Seda, Barbara, Diana, Gina, Seda, Helen, Lee, Melanie, Seda, Felicia, Jen, Bess, Ady, Erica, Stephen, Amy Barbara, Diana, Gina, Seda, subaward related matters. industry-sponsored non-clinical trial research agreements. material transfer agreements. Serves as point of contact for sponsors to reach WCMC for industry-sponsored clinical trial agreement matters. ERF technical issue reporting and assistance. Confidential Disclosure Agreements relating to material transfer agreements and sponsored research agreements. New NIH Policy Regarding Just-in-Time Requests The NIH recently announced a new policy regarding Just-In-Time (JIT) requests. This new policy, which went into effect on April 20, 2012, includes the following: All applications having an impact score of 40 or less will receive a standard notice and request for submitting JIT information. Notices will be sent via automatic message from the NIH era Commons to the Project Director(s)/Principal Investigator(s) two weeks after release of the impact score. Applicants will have up to 60 days from the proposed start date to submit the JIT. It is expected that the number of JIT requests received will increase at WCMC. It is important to remember that a JIT request is not an indication of funding, but rather that the application has reached a level of review where it may be funded and the JIT information is required to make such determinations. Should your application propose animal work or human subjects research, be sure to request your Verification of IACUC Approval Letter and your IRB 310 Form from the IRB and IACUC Offices respectively. For more information, please visit:

4 WBS Request Form The Grants & Contracts Office has created the WBS Request Form in an effort to ensure that all new and competing award accounts provide WCMC staff with the appropriate level of access in SAP. Effective March 23, 2012 as part of the GCO NOA Processing Checklist, all departments and divisions will be required to submit the WBS Request Form for all new & competing awards. The form is available on our website here ** For Department of Medicine grants, please contact Monica Prabudoss for a departmental specific form. TCN Social Media Event The Tri-Institutional Collaboration Network (TCN) will be hosting a Social Media in Research event on May 18 th, 2012 from 10am-1pm in conference room A-126 at Weill Cornell Medical College. The event will explore the use of social media services such as LinkedIn for postdoctoral career planning and the how-to s of seeking alternative employment via social media. The event will also identify the tools of social media for online patient recruitment as well as the future of online requirements for federal researchers using VIVO a research-focused discovery tool that enables collaboration among scientists across various disciplines. Registration information for this event is located at Update on Confidential Disclosure Agreements A Confidential Disclosure Agreement (CDA) ensures confidentiality of proprietary information disclosed between parties. The purpose of a CDA is to enable the parties to review the necessary proprietary information to determine whether they will enter into research collaboration. A CDA is put in place prior to a research agreement and then superseded by a research agreement if the parties decide to collaborate. There is now a distinct listserv that is to be used for the submission and processing of CDAs for Material Transfer Agreements (MTAs) and Sponsored Research Agreements (SRAs). For such submissions, please use sra_mta_cdas@med.cornell.edu. Office of Clinical Trials Administration (OCTA) Reminder: Required Documents for Clinical Trial Agreements Before the Office of Clinical Trials Administration (OCTA) can negotiate a clinical trial agreement, we require receipt of four important documents. Some of these documents are generated internally and others are generally provided by the sponsor. Draft Informed Consent Form (ICF): There is important information in the ICF that can provide guidance to the OCTA Specialist during negotiations. Protocol: If the study is sponsor-initiated, the sponsor will furnish the study team with this document. If the study is investigator-initiated (i.e., WCMC PI authored the protocol), the study team should provide this document. Clinical Trial Synopsis Form (CTSF): This form can be found on the RASP website at This document is an important internal document because it provides the OCTA Specialist with detailed information such as: o the contact information for the sponsor and the research team, o whether the clinical trial will require use of NYPH facilities, o the type of clinical trial, and o whether the protocol is sponsor or investigator initiated. Clinical Trial Agreement Template: This is the template that the OCTA Specialist will negotiate into the final contract. It is most often provided by the sponsor. If the sponsor does not have one, please contact OCTA and one will be provided. The CTA template must be in editable form, (i.e. MS Word) to allow for required edits and revisions. We cannot accept non-editable versions (i.e., PDF) of the template.

5 Research Integrity Anonymous Hotline Available to Report Ethical Concerns A commitment to the highest ethical standards is the foundation of a great university. Underlying everything we do teaching, research, public engagement, and day-to-day operations this foundation is only as strong as our shared understanding of what constitutes ethical conduct. To ensure that everyone working on the university s behalf, from trustees to student employees, understands and adheres to ethical standards, Cornell University has outlined these standards in a formal policy, available at When concerns arise about research, financial matters, environmental health and safety, athletics, and other matters of integrity, the first approach should be to discuss the matter with a colleague, supervisor, department chair, or dean. However, if anonymity is desirable, a hotline is available, by telephone and online. Members of the Cornell community as well as those outside it can use this confidential hotline system to report concerns involving the Ithaca campus, the Weill Cornell Medical College campuses in New York City and Qatar, the New York State Agricultural Experiment Station in Geneva, and other Cornell offices and programs in any location. Both the telephone line ( ) and the website ( are administered by EthicsPoint, a company independent of Cornell. For reporting nonemergency criminal activity on or near the Ithaca campus, the site includes a link to the Cornell University Police Silent Witness Program. I hope and expect that few of us will ever need to use these services. But I am pleased that Cornell has in place a system that faculty, staff, students, and others can use with full confidence that their concerns will be heard while their anonymity is preserved. The integrity of the university depends on our collective efforts to maintain the highest standards of ethical conduct. Thank you all for your dedication and hard work and for strengthening Cornell s reputation for initiative, integrity, and excellence.

6 RASP Telephone Directory Grants and Contracts 407 East 61 st Street, 1 st Floor, RR106, WCMC Box 89 Michelle Lewis, M.S. mil Director, Grants & Contracts/OCTA Amy Zier, MBA, MSW aaz Assistant Director, Grants & Contracts Jennifer Cano jec Grants & Contracts Administrator Diana Gutierrez dig Grants & Contracts Administrator Felicia Andrade fea Grants & Contracts Administrator Hilary Elliot helliot Sr. Grants & Contracts Specialist Stephen Hunt sjh Sr. Pre-Award Manager & International Specialist Bess Jensen eaj Research Administration, Business Analyst Patricia Kennedy pak Subaward Specialist Prahalad Raju prr CFR- Software Development Manager M. Eugenia (Gina) Vergara mev Contract Manager Erica Umberger elu Sr. Grants & Contracts Specialist Ady Villegas-Estrada, PhD adv Sr. Grants & Contracts Specialist Barbara Lau hil Grants & Contracts Aid Mei Ling Acevedo mea Administrative Assistant Office of Clinical Trials Administration 407 East 61 st Street, 1 st Floor, RR106, WCMC Box 305 Helen Barkhudaryan heb Contracts Administrator Seda Galstian seg Senior Contracts Specialist Melanie Lebedowicz,JD mel Senior Contracts Specialist Lee Stetson, JD les Senior Contracts Specialist Mary Kay Wolfe mkw Financial Analyst I Research Integrity 407 East 61 st Street, 1 st Floor, RR106, WCMC Box 305 Rosemary Kraemer, PhD rtkraeme Director, Human Research Protections Program Andrea Campitiello anc Research Administration, Business Analyst Milda Plioplys mip IRB Manager Kristen Rogers krr Research Integrity Administrative Aide II Yaritza Saavedra yas IRB Administrative Aide II Allison Rodriguez alr IRB Administrative Aide II Cynthia Franco cyf IRB Administrative Aide II Kristine Pangilinan krp IRB Administrative Aide II Chad Davis chd IRB Administrative Aide II Amenophis Faussett asf Manager, Conflicts and Compliance Programs Andrew Nicholson, DVM, PhD nicholso Director, Animal Research Protections Program Jennifer Akl jea IACUC Coordinator Aron Arvai ara IACUC Administrative Aide I Lauren Odynocki lao Research Integrity Coordinator Spencer Campbell spc IBC and DSMB Administrative Aide Michael Murphy mgm2003 IBR Administrative Aide Mary Simmerling, PhD mcs Research Integrity Officer Dan Splitgerber das Research Compliance Officer Technology Development 418 East 71 st Street, Suite 61, WCMC Box 4 Brian Kelly, PhD bjk Director, Vice President of CRF Annie Cheng amc Administrative Assistant Carol Dempster, PhD cjd Senior Licensing Professional Joan Falciano jaf Intellectual Property Coordinator Liyan He, PhD lih Senior Licensing Professional Bruce Toman bet Licensing Professional