Research Management Group (RMG)

Roles and Responsibilities

Industry-Funded Clinical Trials (PI initiated and Industry-initiated)

 

 

Start Up Checklists for PIs and Study Coordinators

 

 

 

 

 

 

 

 

Pre-study Start-up

PI and/or Study Coordinator
CT-RMG:
CT RPMs
CT-RMG:
CT Contract Officers
Spectrum

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.

For PI-initiated studies, consults with RMG to create a budget proposal to submit to an industry sponsor. Works through Spectrum Study Navigator to obtain services as needed.

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.

As needed, offers training and advice on study start-up, IRB preparation, hospital contacts, sponsor interactions. Conducts Coordinator orientation.

For PI-initiated studies, provides biostatistical, informatics, and ethics consultations.



Administrative Process Initiation

PI and/or Study Coordinator
CT-RMG:
CT RPMs

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

PI resolves conflicts of interest if necessary, responds to IRB.

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.



Parallel Processing (PP)

PI and/or Study Coordinator
CT-RMG:
CT RPMs
CT-RMG:
CT Contract Officers
Spectrum

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).

Supplies contact information and draft contract to OSR.

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.

Notifies OSR Contracts of new study

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.

Communicates with PI or study coordinator as needed regarding contract terms and conditions.
As needed, consults with RMG or OSR and/or study coordinators on clinical procedures, pricing, regulatory issues, hospital requirements, and clinical and/or operational aspects of the study.

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 coordinate with 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
CT-RMG:
CT RPMs
Spectrum
OTC

Hospital

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.

For device studies, prepares Medicare FI preauthorization packet for submission to Patient Financial Services.

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.

Revises internal budget as needed to match sponsor award.

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.

Tracks submission of Medicare Pre-authorization requests to Patient Financial Services (PFS).

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

Submits Medicare Pre-authorization requests to the Fiscal Intermediary.
 

Award Completion

PI and/or Study Coordinator
CT-RMG:
CT RPMs
CT-RMG:
CT Contract Officers
OSR Accounting

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.

PI signs contract agreements.

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

Sends study materials, final budget, and signed PDRF to OSR.
Completes contract negotiations. Signs contract as institutional official. Obtains PI and sponsor signatures.
Issues Notice of Award, including noting unusual situations such as account set-up, billing and invoicing, equipment, and financial reporting.
Establishes PTA in Stanford accounting system (Oracle) and sends PTA information to DFA.


Conduct of the Study

PI and/or Study Coordinator
Department
Hospital

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.

Responds to sponsor inquiries including monitor visits. Maintains regulatory documents, binders and records related to the study execution.
Reviews weekly reports of patient care expenses, ensuring that research costs are charged to the study (via the 98 account) and routine care costs are charged to insurance.
Works with department financial analyst to monitor effort charged to the study, patient milestones, and payments received.
PI signs Quarterly Certification of expenses. Notifies RMG if there is a protocol amendment or any changes to the CTRP (Clinical Trial Research Planning Workbook) affecting the budget.
Obtains annual renewal from IRB.
Files IRB revision applications as needed when protocol changes are made.

See resources on Spectrum OTC website >>.

If holder of IND or IDE, other additional responsibilities including monitoring and reporting AEs, annual reports to FDA, etc.

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. 

Obtains PI certification quarterly.

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.

Journals research charges to University PTA monthly. 
SPCTRM OTC
CT-RMG:
CT RPMs
CT-RMG:
CT Contract Officers
Serves as liaison with hospital billing for corrections to the CTRP Workbook. Provides ongoing support and advice as needed on clinical and/or operational aspects of study.

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

Receives and processes amendments as needed.

Negotiates any contract amendments.

Obtains no-cost extensions to contracts as needed and requested by PI.


Closeout

PI and/or Study Coordinator
Department
CT-RMG:
CT RPMs
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 final report to IRB.
Submits reports as needed to sponsor. Stores study records appropriately.

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.
Determines appropriateness of funds to remain with Stanford.
As needed, assists Department and PI with closeout process, including resolution of overdrafts.
Reviews PI effort. Closes study account. Transfers balances to income accounts. Works with dept to resolve overdrafts.


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.



Cancer Clinical Trials Office (CCTO)

The Cancer Clinical Trials Office (CCTO) has staff to assist with clinical trial initiation for cancer studies at no charge to the investigator.  Services include protocol development consultation; regulatory documentation preparation and tracking including IRB, GCRC, and IND/IDE; and study budget preparation and management for industry-sponsored clinical trials.  RMG will review the final budget packet for compliance with University sponsored project requirements.  For PI-initiated studies, CCTO and RMG will work with the PI to develop the budget and proposal for RMG submission to the sponsor. To request assistance from the CCTO see their webpage >>


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