Clinical Trial AdministrationClinical Trial AdministrationPresented by:Presented by:

Jill Griffith and Shannon CondonJill Griffith and Shannon Condon

Presentation Overview:Presentation Overview:• Synopsis of Clinical Trial Synopsis of Clinical Trial • Benefits & Importance of Clinical TrialsBenefits & Importance of Clinical Trials• Clinical Trials at MUSC, Environment and Clinical Trials at MUSC, Environment and

Life CycleLife Cycle• Role of Business and Grant ManagersRole of Business and Grant Managers• Open DiscussionOpen Discussion

Clinical Trials

Clinical Trials-What are Clinical Trials-What are they?they?

Interventional Study - Studies to Interventional Study - Studies to determine whether a technology is safe determine whether a technology is safe and effective in humansand effective in humans Technology may be a diagnostic tool, a drug, Technology may be a diagnostic tool, a drug,

a device, or a behavioral intervention.a device, or a behavioral intervention. Observational studies - Individuals are Observational studies - Individuals are

observed and their outcomes are observed and their outcomes are measured by the investigators.measured by the investigators.

Clinical Trials-Who sponsors Clinical Trials-Who sponsors them?them? Government Agencies (e.g. NIH) - (translational res.)Government Agencies (e.g. NIH) - (translational res.)

Pharmaceutical IndustryPharmaceutical Industry Bio-Tech CompaniesBio-Tech Companies

ClinicalClinical Trials-Who can participate?Trials-Who can participate? Determined by inclusion / exclusion criteriaDetermined by inclusion / exclusion criteria Purpose – not to reject personally, but rather Purpose – not to reject personally, but rather

identify appropriate individuals and keep them safe.identify appropriate individuals and keep them safe.

Clinical Trials-BenefitsClinical Trials-Benefits Advancement of knowledgeAdvancement of knowledge Contribute to medical researchContribute to medical research Access to TherapiesAccess to Therapies Access to Network of ScientistsAccess to Network of Scientists Source of SupportSource of Support Residual FundsResidual Funds Patient CompensationPatient Compensation

Clinical Trials.govClinical Trials.gov 20052005

International committee of Medical Journal Editors International committee of Medical Journal Editors (ICMJE) mandated registration of clinical trials as a (ICMJE) mandated registration of clinical trials as a condition for accepting manuscripts for publication.condition for accepting manuscripts for publication.

20072007 Food and Drug Administration Amendments Act of Food and Drug Administration Amendments Act of

2007 (US Public Law 110-85) 2007 (US Public Law 110-85) Expands requirements for clinical trial registrationExpands requirements for clinical trial registration

Trials must be registered before onset of enrollmentTrials must be registered before onset of enrollment

MUSC Corporate Awards per MUSC Corporate Awards per FYFY

$20,729,377

$22,816,888

$19,985,178

$24,150,597

$34,285,583

$17,299,807

$-

$5,000,000

$10,000,000

$15,000,000

$20,000,000

$25,000,000

$30,000,000

$35,000,000

FY03 FY04 FY05 FY06 FY07 FY08Fiscal Year

Corporate Awards

Corporate Aw ards

MUSC FY07 Research MUSC FY07 Research ExpensesExpenses

9%

60%

2%

7%

4%

9%

2%5% 2%

CORPORATE SPONSORS

NATIONAL INSTITUTES OFHEALTH

DEPARTMENT OF ENERGY

NSF/SCUREF/OTHERFEDERAL

DEPARTMENT OFCOMMERCE

DHHS (NON NIH)

DEPARTMENT OF DEFENSE

FOUNDATIONS

STATE & OTHER SUPPORT

Clinical Trials- MUSC Clinical Trials- MUSC EnvironmentEnvironment

Compliance OversightCompliance Oversight Divisional ApprovalDivisional Approval Departmental ApprovalDepartmental Approval IRB Approval – Regular, Expedited, Exempt IRB Approval – Regular, Expedited, Exempt

ReviewReview ORSP ApprovalORSP Approval

Departments and CentersDepartments and Centers Leadership – Division Directors, Business MgrsLeadership – Division Directors, Business Mgrs Personnel- PIs, Study Coordinators, Data Personnel- PIs, Study Coordinators, Data

ManagersManagers FacilitiesFacilities Pre & Post Award Management Pre & Post Award Management Data and Financial SystemsData and Financial Systems

Life Cycle of a Sponsored Life Cycle of a Sponsored ProjectProject

Proposal Preparation

Sponsor's Review Award:

No Cost Extension Closeout

1st 2nd 3rd

Proposal Review

Negotiation and Acceptance

Budget Period Budget Period Budget Period

Institutional Review

Submission to Sponsor

Project Period

Pre & Post Award ProcessPre & Post Award ProcessPI has an idea Closeout Process

Search for funding Grant manager continuously reconciles & monitors faculty effort

Writes protocol Grant manager meets regularly w/ PI and Coordinator for AR review

Complete sponsor & university forms for grant submission GCA notifies Dept & Dept sets-up UDAK in UMS

Build internal budget ORSP sends 'NOA" to GCA for UDAK establishment

Contact sponsor for budget negotiation ORSP reviews, negotiates, & executes contract w/ sponsor

Route blue sheet, budget, and protocol to Chair for approval Route blue sheet, budget, and protocol to ORSP for approval

Role of the Grant ManagerRole of the Grant Manager

Sponsor

PIs

Study Coordinators

IRB

ORSP

GCA

Committees

Department Grant

Manager

Role of Grant ManagerRole of Grant Manager Provide support to Investigators to build Provide support to Investigators to build

infrastructure within their respective research infrastructure within their respective research programs and manage day to day operations.programs and manage day to day operations. Financial ManagementFinancial Management Understand restrictions and allowancesUnderstand restrictions and allowances Strengthen internal controls and demonstrate Strengthen internal controls and demonstrate

accountabilityaccountability Provide leadership and guidance to investigatorsProvide leadership and guidance to investigators Operations ManagementOperations Management Human ResourcesHuman Resources Purchasing/ContractingPurchasing/Contracting Space AllocationSpace Allocation

Keys to SuccessKeys to Success CommunicationCommunication Predicting the Flow of Predicting the Flow of

IncomeIncome Consistently Applying Consistently Applying

Practices and PoliciesPractices and Policies Meeting Financial and Effort Meeting Financial and Effort

Reporting Requirements in a Reporting Requirements in a timely fashiontimely fashion

ComplianceCompliance

CommunicationCommunication Role of Study CoordinatorRole of Study Coordinator

ProtocolProtocol and clinical managementand clinical management Role of Principal InvestigatorRole of Principal Investigator

ProtocolProtocol,, clinical, & financial management clinical, & financial management What is the key to effective communication?What is the key to effective communication?

TrustTrust An understanding of each key person’s roleAn understanding of each key person’s role Creating an environment of communicating Creating an environment of communicating

regularly and being a team playerregularly and being a team player

Predicting the Flow of Predicting the Flow of IncomeIncome

Understand payment terms on grants and Understand payment terms on grants and contractscontracts Know benchmarksKnow benchmarks Know payment schedule & payment amountsKnow payment schedule & payment amounts Know common invoiceable items; i.e., advertisingKnow common invoiceable items; i.e., advertising

Prompt payment of invoicesPrompt payment of invoices Slow receipt of income v. timely posting of Slow receipt of income v. timely posting of

expensesexpenses Strategically planning for gaps in funding or Strategically planning for gaps in funding or

cost over runscost over runs

ConsistencyConsistency Different clinical specialtiesDifferent clinical specialties Different sponsorsDifferent sponsors Different protocolsDifferent protocols Standardizing accounting proceduresStandardizing accounting procedures Standardizing operating proceduresStandardizing operating procedures Creating a climate where the PI can trust that Creating a climate where the PI can trust that

his grant manager will keep in orderhis grant manager will keep in order

ReportingReporting Financial ReportingFinancial Reporting

Budget to Actual Budget to Actual Standard Data to provide PIsStandard Data to provide PIs

Earned v Actual incomeEarned v Actual income Actual expenses, Actual expenses, per categoryper category

Outstanding commitmentsOutstanding commitments Projected fund balanceProjected fund balance

Effort ReportingEffort Reporting Certifying on a quarterly basis how percentage of time Certifying on a quarterly basis how percentage of time

(effort) was spent.(effort) was spent. Determining whether actual distribution and payroll Determining whether actual distribution and payroll

distribution match and how to handle variances.distribution match and how to handle variances.

Reporting Reporting Progress/Final Reporting to the SponsorProgress/Final Reporting to the Sponsor

Reporting to the sponsor annually on the progress of the Reporting to the sponsor annually on the progress of the research, and submitting final reports as required by the research, and submitting final reports as required by the sponsor.sponsor.

Meeting required deadlines of annual and final reporting Meeting required deadlines of annual and final reporting are usually contingent upon additional funding.are usually contingent upon additional funding.

Close out reporting, cooperative effort amongst PI, Grant Close out reporting, cooperative effort amongst PI, Grant Manger, ORSP and GCAManger, ORSP and GCA

ComplianceCompliance Rules and Regulations we must Rules and Regulations we must

followfollow A few examples:A few examples:

Protection of Human SubjectsProtection of Human Subjects HIPPAHIPPA OMB CircularsOMB Circulars University Policies and ProceduresUniversity Policies and Procedures

Any Questions?Any Questions?