Clinical Trials Shared Resource

Provide assistance to investigators in the writing of LOIs, protocols and related documents including informed consents, progress reports, abstracts, publications and presentations.  

• Assistance in development and review of LOI’s with investigators
• Coordination of project team to develop protocol and other related components (Project Management)
• Assistance in development of draft budget based on concept
• Assistance in development of draft protocol, specifically related to adverse event reporting, Data Monitoring section, registration, data submission
• Work with sponsor, if applicable, regarding budget templates, deadlines, and review processes.
• Coordinate and provide assistance in development of abstracts and presentations
• Assist in development and review of publications

Provide centralized management of cancer clinical trials finances; including development of detailed budgets, assisting in contract negotiations, invoicing, dispersing funds for study related expenses, as well as provide quarterly PI account summary reports.

• Development of final budgets, including negotiation of research discounts for procedures and services
• Work with the Research Institute budgets and contracts office in finalization of study budgets, execution of contracts and obtaining a study billing number
• Route approved itemized study budgets and study billing numbers to appropriate investigator and research staff
• Track and invoice completed services for sponsor reimbursement
• Requisitioning support of investigators related to study related bills not Standard of Care (SOC)
• Create and provide quarterly reports to PI’s as to study funds invoiced, received and paid for study expenses

Provide oversight and assurance that protocols are conducted in accordance with institutional, state and federal regulations.  The RRAO consists of two major components, the Regulatory Affairs unit and the Research Assurance Unit, which includes the PRMC and DSMB functions as well as the QA/QC Program.

• Regulatory support
• Completion and submission of PRMC and HSC applications
• Completion of other study-start up regulatory documents (institutional checklists, feasibility questionnaires, radiation safety applications, etc.)
• Consent form development
• IND completion and submission
• Clinicaltrials.gov registration
• Completion and submission of IRB amendments/revisions for protocols and consent forms
• Coordinate, prepare for and participate in outside sponsor pre-study qualification visits, study initiation, monitoring and close-out visits
• Complete and submission of adverse event reports
• Participate in DWG meetings and provide comprehensive updates regarding DWG studies, accrual, etc.
• Assist investigators in membership applications, etc. for cooperative groups and committees
• Support the MCA sites related to regulatory support and SWOG membership
• QA/QC Program
• Coordinate and participate in internal audits, QA and QC reviews of therapeutic and non-therapeutic studies
• Coordinate and lead subsite qualification visits
• Provide site initiation to sub-sites, monitoring visits, close-out visits
• Prepare audit/monitoring visit reports
• PRMC Committee support
• Provide PRMC Coordinator to create agenda’s for meetings, select and follow-up with reviewers, coordinate meeting, take and distribute minutes and approval letters to PI’s, coordinators and committee members
• DSMB Committee support
• Provide DSMB Coordinator to create agenda for meetings, route serious adverse events to medical monitors for review between meetings, compile adverse events and serious adverse events by study for review at DSMB meetings, take and distribute minutes and approval letters to PI’s, coordinators, committee members and Office of Compliance

Provide the necessary research nursing, study coordination, clinical data management, correlative study coordination and investigational pharmacy resources to efficiently conduct protocols.

• Study Coordinator/Research Nursing support
• Obtain informed consents
• Schedule study related procedures
• Write orders for study subjects
• Work with investigational pharmacy
• Enrollment, registration and randomization of subjects
• Work with investigator related to management of subject while on study
• Adverse event assessment and reporting (MedWatch)
• Prepare for and participate in site initiation visits, monitoring visits and study close-out visits
• Participate in monthly DWG meetings, provide updates on subject accrual issues, screenings, etc.
• Clinical Data Management support
• Work with investigator, nurses and Center for Biostatistics and Advanced Informatics CRIS personnel on data collection forms as well as validation of forms
• Extract data from source documentation
• Complete Case Report Form’s  (CRFs) (electronic and paper)
• Submit data to relevant sponsor or in CRIS
• Respond to and resolution of data queries
• Prepare for and participate in site initiation visits, monitoring visits and study close-out visits
• Participate in monthly DWG meetings and provide updates to group
• Research Laboratory/Correlative Studies support
• Receive and track specimen study blood collection kits from outside sponsors, order new kits as needed or when expiring
• Process study specific related blood specimens
• Ship study specimens to sponsor, central lab or other required facility
• Obtain radiology and pathology reports and materials for submission to sponsor
• Compile and ship study kits to subsites for specimen collection and shipment
• Prepare for and participate in site initiation visits, monitoring visits and study close-out visits