Roles and Responsibilities

• Clinical Trial Start Up Checklist
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• Investigator-initiated Clinical Trial Start Up Checklist
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Coordinates submission of FDA 1572 form.
PI signs confidentiality agreements.
Participates in Investigator/start-up meeting.
Receives protocol from sponsor.
Assesses study feasibility – staff, facilities, etc.

As needed, advises on feasibility or other requests. May prepare a feasibility budget prior to IRB submission, if requested by the PI/coordinator.

For PI-initiated studies, develops budget and reviews proposal for submission.

As needed, advises on confidentiality agreements. OSR will sign off as institutional representative, if required by the sponsor.

Prepares IRB submission. 
Negotiates consent form with sponsor. 
IRB notifies RMG of submission. 

Receives notification from IRB of application submission or from PI of new study.
Obtains copies of IRB application as needed.
Reviews study protocol and informed consent to be sure study qualifies for CT F&A (Facilities and Administrative Cost Rates) >>  and to determine if a contract is necessary.

Forwards sponsor payment schedule and contact information to RMG. Downloads and completes CTRP Workbook, available on the Spectrum website through Study Navigator, separating standard of care (covered by insurance) versus research costs (paid by the sponsor and included in the study budget).

Establishes initial institutional record for the study and tracks its status until awarded.
Sends acknowledgement to PI of receipt of study information/application and
notifies PI of missing requirements needed to commence budgeting; acknowledgment will also provide the name of the CT RPM who will work with the PI, and the SPO #, the unique institutional designation for every sponsored project.

Receives study notification from RMG. Obtains minimum required items from sponsor or PI to begin contract negotiations: 1) draft contract; (2) draft protocol; and (3) PI name.  Creates log to track status and notifies PI of assigned Contract Officer. Begins contract negotiations.

Determines study eligibility for Medicare NCD.
Identifies patient care costs in the study that are routine care versus research costs to be paid by the sponsor.  Completes Clinical & Translational Research Planning Workbook (CTRP Workbook) >>.
Determines the level of effort required for study personnel to execute a study.
Identifies the locations where the research related items will be performed.
If study qualifies under NCD, works with CT RPM to determine if any research costs can be billed to insurance.
Consults with hospital ancillary services experts to correctly analyze feasibility, identify protocol required procedures and to schedule study subjects with hospital specialty areas.
For procedures that are not included on the CTRP workbook, provides CPT codes for research related procedures.
May need to provide patient information for unusual or complex procedures in order to obtain billing reports.
Department DFA participates in approvals of unusual circumstances.

Reads protocol, IRB application, consent. Reviews sponsor payment schedule and contract. Meets with PI/Study Coordinator to evaluate protocol, obtain budget information, and review payment terms.
Provides guidance on NCD determination and whether research costs can be billed to insurance.
Compares CTRP Workbook vs consent vs payment schedule vs protocol to ensure consistency.
Acquires prices from available databases or Hospital Departments. Creates budget, revises as needed, and obtains PI approval.
Consults with OSR, IRB, Hospital, Spectrum OTC, PFS as needed.
Obtains Hospital approval for device studies.
Negotiates budget and payment terms with sponsor.
Obtains waivers as needed.
Obtains Medicare FI approval prior to completing budget.
Revises payment schedule to match approved and negotiated budget.

For PI-initiated studies, RMG prepares budget and obtains approvals prior to submission of proposal to the funding agency.

Provides budget/billing training, advises on hospital or regulatory issues as needed. Coordinates RAC review of studies with issues related to hospital billing or adverse event.

Provides technical assistance in determining appropriate codes for tests/procedures. Establishes discounts for research prices. Provides pricing information as needed. 

Approves final budget.
PI signs RPS (Research Participant Services form).
Reviews, completes and PI signs PDRF (Proposal Development Routing Form).
Department administrator and chair sign and approve PDRF.

Initiates PDRF and routes to PI and other approvers.
Notifies COI administrator if COI disclosed on PDRF but not in IRB application.

Requests 98 account (SHC) or mnemonic (LPCH) account after PTA is provided by OSR. Insures that all study subjects are correctly consented, registered or admitted for study-related services.
Supervises recruitment, insures clinical appropriateness, and monitors study requirements.
Submits study subject enrollment  information to PFS to ensure proper and timely billing of patient care costs.
Tracks enrollment and patient progress through the study protocol.

Monitors study expenditures and receipts in close cooperation with the Study Coordinator.
Reconciles study account monthly.
Coordinates the invoicing process with ORA Accounts Receivable to invoice sponsor.
Is responsible for all standard accounting procedures, including monitoring allocability and PI and staff effort charged to study, tracking of cost sharing commitments, etc. 

Establishes 98 (SHC) or mnemonic (LPCH) accounts. Based on RPS (Research Participant Services) form bills third party payers or research accounts as appropriate.
Works with PI to schedule subjects for hospital procedures.
Issues weekly and monthly reports to PIs on patient care charges for enrolled study subjects.

Processes any needed corrections to the CTRP Workbook that affect the budget and amends budget as needed.

Negotiates any contract amendments.

Ensures that all allocable costs have been charged to the study.