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

Doreen Robinson, PhD, CRASAVP for Sponsored Research

24 April 2014

Presentation to the Clinical Research Network

GUMC Office of Sponsored ResearchFunction• 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

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• 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

OSR Pre-Award Roles: R&D

• 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 develop and negotiate external and internal budget– Becomes part of the final agreement

OSR Pre-Award Roles: CTAs

• 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

OSR Post-Award Functions

Activity Submission to OSRDepartment

Submission to OSR

PACTSIndustry-

Sponsored CTA

TRACSFederal or

Private Grant Proposal

Review, Approval,

Submission

Contract & Budget Negotiation

STARSSub-Award Setup

STARSSub-Award Setup(Additional Sites)

TRACS: https://georgetownresearch.interneer.com/intellect/

PACTS: https://georgetown.interneer.com/intellect/

STARS: https://georgetownsubs.interneer.com/intellect/

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

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

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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?

Complete transmittal PI Review* PI Assurance Dept Chair

Review*

CTO Budget Negotiation*

OSR Contract Negotiation*

OSR Management

Review*

PACTS CTA Initiation Process

• 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.

PACTS: https://georgetown.interneer.com/intellect

Office of Sponsored Research (OSR) Website

http://gumc.georgetown.edu/osr/

Office of Sponsored Research (OSR) Website

http://gumc.georgetown.edu/osr/

PACTSPre-Award Clinicals Tracking System

GU Password

GU NetID

We can set this up with a Medstar email address

PACTS Activity Emails

Pre-Award Process for GUMC Industry Sponsored CTA

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Research Team

Department ChairIRB TCO

CTO

OSR

CRU

Sponsor

Protocol etc.

Approval

ReviewCTA, Protocol etc.

CDA Request Transmittal Patient Care Costs

Cost Analysis

Budget Prep

CRU App etc.

PatientEnrollment

ExecutedContract

Negotiation

Contract Review

BudgetIP Review

RX Account

Pre-Award Process for LCCC Industry Sponsored CTA

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Research Team

Department ChairIRB TCO

OSR

Sponsor

Protocol etc.

Approval

ReviewCTA, Protocol etc.

CDA Request Transmittal Patient Care Costs

Cost Analysis

Budget Prep

PatientEnrollment

ExecutedContract

Negotiation

Contract Review

IP Review

RX Account

CMRO

Budget Review

Approved Budget

Budget

CTO

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 17

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 required to 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

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What are Possible Holdups?Reviews, Approvals, Coordination

Departmental

Working Agreement Elements Serially vs. in Parallel

Lack of Communication with Responsible GUMC Offices

Insufficient Understanding of GUMC

Requirements/Processes

Sponsor-Related

Inflexible Terms & Conditions

Slow Response to GUMC Requests

GUMC/MedStar Agreement

OSRInterface with Department

Interface with Sponsor

Interface with GUMC Offices

Negotiate & Finalize Terms & Conditions

OTC

Negotiate CDA with Sponsor

Negotiate IP Terms with Sponsor

Interface with OSR & Other GUMC Offices

CTO

Work Budget with Department

Negotiate Budget with Sponsor

Interface with OSR & Other GUMC Offices

Additional Sites

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

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Name Title Responsibilities Phone Email

Doreen Robinson Director, Office of Sponsored Research, Sr. Associate VP for Sponsored Research

Strategic management, outreach, coordination 202-687-1390 dar82@ georgetown.edu

Trudy Bright Deputy Director Operations, management, coordination, training 202-687-1227 brightt@georgetown.edu

Manuel Corday Assistant Director Systems & grants management, G&C Officer for Orthopedics, SNHS, Lung Biology

202-687-1372 cordaym@georgetown.edu

Elisabeth Crigler Pre-award Manager Pre-award review, submission 202-687-0020 criglere@georgetown.edu

Serena Ody Grants Specialist Pre-award budgets 202-687-8584 artiss@georgetown.edu

Clairice Lloyd Sr. Grants & Contracts Officer Program Projects & Center Awards 202-687-1207 lloydc@georgetown.edu

Marjan Mobini Sr. Grants & Contracts Officer Lombardi Comprehensive Cancer Center 202-687-7866 mobinim@georgetown.edu

Susie Vernon Sr. Grants & Contracts Officer Anesthesia, Biochemistry, Cardio & Thoracic Surgery, Cell Biology, Family Medicine, Microbiology, Neurology, Neuroscience, Pathology, Pharmacology, Physiology, Psychiatry, Surgery

202-687-4344 nmd@georgetown.edu

Bonnie Regini Sr. Grants & Contracts Officer Infectious Disease, Medicine, Neurology (CTs), Ob-Gyn, Pediatrics, Plastic & Reconstructive Surgery, Radiology, Rheumatology, Transplant, VA

202-687-1306 bmw@georgetown.edu

Shawnna Artis Grants & Contracts Specialist,Office Coordinator

Sub-awards, Office Coordination 202-687-8314 sma63@georgetown.edu

Armineh Ghazarian

Grants & Contracts Specialist,Office Coordinator

Sub-awards, Office Administration 202-687-4218 sev8@georgetown.edu

OSR Contact Information

Name Title Phone Email

Office of Technology Commercialization

Ruchika Nijhara Director 202-687-3721 rn86@georgetown.edu

Azra Chughtai Executive Assistant 202-687-7424 acf43@georgetown.edu

Clinical Trials Office

Tony Hursey Director 202-687-6408 tlh3@georgetown.edu

Pam Rampersaud Clinical Trials Project Manager 202-687-1207 pr36@georgetown.edu

Office of Regulatory AffairsSheila Cohen Zimmet SAVP for Regulatory Affairs 202-687-8437 zimmets@georgetown.edu

Presh Johnson-Arabitg Deputy Conflicts Officer and Regulatory Affairs Associate

202-687-3354 pj186@georgetown.edu

Related Offices Contacts