Role of the GUMC Office of Sponsored Research in Clinical Research Activities

1. Role of the GUMC Office of Sponsored Research in Clinical Research Activities Doreen Robinson, PhD, CRA SAVP for Sponsored Research 24 April 2014 Presentation to the Clinical Research Network

2. GUMC Office of Sponsored Research Function • Provide pre- and post-award (pre-financial) research administration support to Georgetown University Medical Center (GUMC) and Medstar Georgetown University Hospital (MGUH) investigators conducting sponsored research R&D Grants and Contracts…including Federal Clinical Trials • Investigator-initiated grant applications • Federal cooperative agreements or contracts • Multi-center project or multi-site clinical trial • Government, non-profit and for-profit organizations Industry-Sponsored Clinical Trials • Investigator-initiated • Sponsor-initiated

3. OSR Pre-Award Roles: R&D • Review and approve all GUMC R&D applications to be submitted to federal and non-federal sponsors • Sponsor-dictated content (abstract, specific aims, research strategy, biosketches, etc.) • University-required content (transmittal, conflict of interest, PI assurance, IRB, risk management, IP issues, etc.) • Review solicitations to ensure that proposals comply with sponsor requirements & guidelines • Review proposal budgets to ensure that costs are calculated correctly • Submit completed applications to sponsors • Federal applications and some foundations

4. OSR Pre-Award Roles: CTAs • Negotiate industry-sponsored clinical trial agreements • Authorized Organizational Representative for GUMC and MGUH CTAs • Coordinates and collaborates with: • GUMC Clinical Trials Office (CTO): budgets • GUMC Regulatory Affairs: IRB, subject injury, COI etc. • GU General Counsel: indemnification, governing law, etc. • GU Technology Commercialization: IP, publication & data rights, etc. • Other relevant offices • GUMC CTO works with PI and clinical staff to developand negotiate external and internal budget • Becomes part of the final agreement

5. OSR Post-Award Functions • Receive, review and accept award notices • Process resulting Sponsored Program Award Notices (SPANs) • Establish RX (Restricted Access) accounts • Handle issues pertaining to: • Award budgets • Sub-award Agreements • Independent Contractor Agreements • No-cost extension requests • Progress reports • All other research-related administrative award issues that require prior approval

6. Activity Submission to OSR DepartmentSubmission to OSR PACTS Industry-Sponsored CTA TRACS Federal or Private Grant Proposal TRACS: https://georgetownresearch.interneer.com/intellect/ Review, Approval, Submission Contract & Budget Negotiation PACTS: https://georgetown.interneer.com/intellect/ STARS Sub-Award Setup (Additional Sites) STARS Sub-Award Setup STARS: https://georgetownsubs.interneer.com/intellect/

7. TRACS/PACTS/STARS Benefits • Transparency • Principal Investigators, Chairs, administrators have access to current and previously submitted proposal information • Accountability • Tracks submission progress and current “owner” • Identifies outstanding items (e.g., IRB approval) • Efficiency • Electronic routing eliminates need for paper routing and signatures • Dashboard facilitates tracking of many proposals at once • Effective Communication • Efficient information transfer • CTA-related attachments and system notes can be accessed remotely by multiple parties simultaneously

8. OSR Requirements for CTAs • Fully-executed Confidentiality Disclosure Agreement (CDA) • Negotiated by GUMC Office of Technology Commercialization (OTC) • NOT the clinical investigator or other hospital personnel • Note: some sponsors require a fully executed CDA prior to sending the study protocol • Completed eTransmittal Form in PACTS (see OSR website) • Draft Clinical Trial Agreement from sponsor • Study Protocol • Sponsor Contact Information (POC, email, phone etc.) • Additional Questions

9. OSR Additional Questions • In PACTS • Is study PI-initiated or sponsor-initiated? • PI initiated: Did investigator(s) write or contribute to the protocol? • Phase of Trial • Outside of PACTS • Has protocol been submitted for IRB review? • Compassionate use? • Zero dollar study? • Has CTO initiated budget negotiations with the sponsor? • Additional sites? Medstar? Others? • Is GHUCCTS involved? If so, has GHUCCTS been contacted?

10. PACTS CTA Initiation Process PACTS: https://georgetown.interneer.com/intellect Complete transmittal PI Review* PI Assurance Dept Chair Review* CTO Budget Negotiation* OSR Contract Negotiation* OSR Management Review* • For steps marked with an asterisk, the eTransmittal can be returned to the submitter for clarifications or changes. • The exchange is a direct interaction between the person reviewing and the submitter – the transmittal will not need to go through the approvals that have already been done again.

11. Office of Sponsored Research (OSR) Website http://gumc.georgetown.edu/osr/

12. Office of Sponsored Research (OSR) Website http://gumc.georgetown.edu/osr/

13. PACTSPre-Award Clinicals Tracking System GU NetID GU Password

14. PACTSActivity Emails We can set this up with a Medstar email address

15. Pre-Award Process for GUMC Industry Sponsored CTA Research Team CRU CTO CRU App etc. Patient Care Costs CDA Request Protocol etc. Transmittal TCO IRB Department Chair Cost Analysis CTA, Protocol etc. Review Budget Prep Sponsor Approval IP Review OSR Budget Contract Review Negotiation Patient Enrollment Executed Contract RX Account

16. Pre-Award Process for LCCC Industry Sponsored CTA Research Team CMRO Patient Care Costs CDA Request Protocol etc. Transmittal Cost Analysis TCO IRB Department Chair Budget Prep CTA, Protocol etc. Review Sponsor Budget Approval IP Review OSR CTO Contract Review Budget Review Negotiation Approved Budget Patient Enrollment Executed Contract RX Account

17. Tips for Faster CTA Negotiation • Contact OTC early to negotiate a CDA • Especially if sponsor requires it before sharing the study protocol • Enter required information in PACTS • Communicate early and often with OSR • Especially…competitive enrollment, additional sites, compassionate use, zero dollar studies • Engage responsible GUMC offices to work various elements of the agreement in parallel • OTC: CDA execution • IRB: Protocol approval • CTO: budget development, negotiation, approval • OSR: review, approval and coordination with other university offices • Risk management • Notification from IRB of protocol approval • OTC: CTA may required intellectual property (IP) negotiations • University Counsel: GUMC/MedStar relationship, indemnification • Check PACTS notes and follow up with responsible offices

18. Finalizing a CTA……and Starting Enrollment • DO NOT set up a site visit until OSR has completed negotiations and has a fully executed agreement • Budget and contract negotiations must be finalized before an agreement can be fully executed (signed by sponsor and GU rep) • OSR establishes and maintains an RX account • Notice of IRB approval is requiredto set up an RX account • Basis of the RX account is the internal budget prepared by CTO • Any agreement modifications will be executed by OSR • Departmental Responsibilities • Coordinate with OSR to issue Personnel Service Agreements (PSAs) for MGUH personnel (issue subawards for other Medstar hospitals) • Adjust salary distribution for study personnel

19. What are Possible Holdups? Reviews, Approvals, Coordination CTO OTC OSR Interface with Department Negotiate CDA with Sponsor Work Budget with Department Interface with Sponsor Negotiate IP Terms with Sponsor Negotiate Budget with Sponsor Interface with GUMC Offices Interface with OSR & Other GUMC Offices Negotiate & Finalize Terms & Conditions Interface with OSR & Other GUMC Offices Departmental Sponsor-Related Inflexible Terms & Conditions Working Agreement Elements Serially vs. in Parallel Slow Response to GUMC Requests Lack of Communication with Responsible GUMC Offices GUMC/MedStar Agreement Insufficient Understanding of GUMC Requirements/Processes Additional Sites

20. Communications with Sponsored Research • Notify OSR of: • Change of Principle Investigator (PI) • No cost extension request • Change in number of study subjects or number of visits • Budget must be modified • Change in study protocol • IRB re-review is required • A modified budget is required • Study cancellation or suspension • Study termination based on a serious adverse event • Study completion • RX account closeout

21. OSR Contact Information

22. Related Offices Contacts