Roles and Responsibilities

Clinical Trials

Sponsor Contact with PI
Process Initiation
Parallel Processing (PP)
Budgeting
Award Completion
Conduct of the Study
Closeout
VA/PAIRE Studies

**Initial Sponsor Contact**
PI and/or Study Coordinator	RMG	SPCTRM	OSR Contracts
Coordinates submission of FDA 1572 form. PI signs confidentiality agreements. Participates in Investigator/start-up meeting. Receives protocol from sponsor. Assesses study feasibility.	RMG: As needed, advises on feasibility or other requests. May prepare a feasibility budget.	SPCTRM: As needed, offers advice on study start-up, IRB preparation, hospital contacts, sponsor interactions. Provides training.	OSR Contracts: As needed, advises on confidentiality agreements.

**Process Initiation**
PI and/or Study Coordinator	RMG
Prepares IRB submission, forwarding copies of all materials to RMG. PI resolves conflicts of interest if necessary	Receives notification from PI that trial will be commencing. Establish initial institutional record for the study and tracks its status until awarded. Notifies PI of requirements needed to commence parallel processing. Obtains copies of IRB application as needed.

**Parallel Processing (PP)**
PI and/or Study Coordinator	RMG	OSR Contracts	SPCTRM
Prepares and submits the PP Packet with study protocol, sponsor payment schedule, and contact information to RMG.	Receives PP Packet from PI. Forwards to OSR Contracts to initiate contracting process. Monitors waivers and other internal requirements. Reviews study purpose to be sure study qualifies for CT F&A (Facilities and Administrative Cost Rates).	Receives PP Packet from RMG. Tracks status and notifies PI of assigned Contract Officer. Begins contract negotiation process. Discusses contract issues with PI, Risk Management, General Counsel, and Office of Technology Licensing	As needed, consults with PI and/or study coordinators on technical procedures, pricing, and study requirements.

Definition of Parallel Processing (PP):
The process that supports simultaneous budget development and negotiation, contract negotiation, and IRB review in order to expedite commencement of a study. RMG will send copies of all contract-related documents (the PP packet) to the OSR contract office once we receive documents (study protocol, etc.) for a new study from the IRB or the PI. This allows RMG, OSR, and the IRB to begin their review and negotiation processes in parallel, rather than sequentially.

**Budgeting**
PI and/or Study Coordinator	RMG	SPCTRM	Hospital
Completes Clinical & Translational Research Planning Workbook (CTRP Workbook). Consults with hospital ancillary services experts to correctly analyze feasibility, identify protocol required procedures and to schedule study subjects with hospital specialty areas. 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 and review payment terms. Acquires prices from available databases or Hospital Departments. Creates budget and obtains PI approval. Negotiates budget and payment terms with sponsor. Obtains waivers as needed.	SPCTRM provides budget/billing training , advises and helps to determine study requirements as needed.	Provides technical assistance in determining appropriate codes for tests/procedures. Establishes discounts for research prices.

**Award Completion**
PI and/or Study Coordinator	RMG	OSR Contracts	OSR Accounting
Approves final budget. Completes and signs SU-42. Signs agreements. Signs RPS (Research Participant Services form). See Staff only links on the SPCTRM website.	Initiates SU-42 and routes to PI. Routes study materials and final budget to OSR.	Coordinates submission of protocol to Adverse Events panel, if needed. Completes contract negotiations. Issues Notice of Award.	Establishes study account.

**Conduct of the Study**
PI and/or Study Coordinator	Department	Hospital
Requests 98 account (SHC) or mnemonic (LPCH) account. Insures that all study subjects are correctly registered or admitted for study-related services. Supervises recruitment, insures clinical appropriateness, and monitors study requirements. Notifies RMG if there is a protocol amendment or any changes to the CTRP (Clinical Trial Research Planning Workbook) (define & link) affecting the budget. Notifies IRB of any protocol amendments. See resources on SPCTRM website.	Monitors study expenditures and receipts in close cooperation with the Study Coordinator. Coordinates the invoicing process, either directly with sponsor or notifies ORA Accounts Receivable to invoice sponsor. Is responsible for all standard accounting procedures, including monitoring allocability and PI effort charged to study.	Establishes 98 (SHC) or mnemonic (LPCH) accounts. Based on RPS (Research Participant Services) forms bills third party payers or research accounts as appropriate. Provides weekly/monthly billing statements to Study Coordinator. Applies discounts to hospital charges. Journals research charges to University accounts monthly
SPCTRM	RMG	OSR Contracts
Liaisons with hospital billing for corrections to the CTRP Workbook. Provides research clinic space as needed.	Processes any needed corrections to the CTRP Workbook. Receives and processes amendments as needed.	Negotiates any contract amendments.

**Closeout**
PI and/or Study Coordinator	Department	RMG	OSR Accounting
Verifies that all Case Report forms have been submitted and that all study requirements have been met, including any final reports. Insures that all allocable costs have been charged to the study. Approves final accounting and verifies that funds to remain with Stanford have been appropriately earned. Submits closeout letter to IRB. Submits reports as needed to sponsor.	Ensures that all allocable costs have been charged to the study. Reviews study receipts with Coordinator to insure that all funds due Stanford have been received, and that all funds received have been earned.	Reviews PI effort. Determines appropriateness of funds to remain with Stanford. As needed, assists Department and PI with closeout process, including resolution of overdrafts.	Closes study account. Transfers balances to income accounts. Works with dept to resolve overdraft.

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**VA/PAIRE Studies**
If patients are enrolled at the VA, the PI and the VA need to work with PAIRE to develop a budget and negotiate the budget and contract directly with the sponsor. If a Stanford PI requires use of VA space or personnel to conduct a clinical trial, PAIRE will need to prepare a budget for those costs and submit it to RMG.