FULL OPERATIONS

LIMITED OPERATIONS

AFT sponsor

 Pharmaceutical collaborator sponsor

AFT holds IND

 Pharmaceutical collaborator holds IND (regulatory)

AFT responsible for entire conduct of the study

 Pharmaceutical collaborator responsible
 for entire conduct of the study

Site contracts are with AFT

 Site contracting responsibilities determined per
 agreement with collaborators

Pharmaceutical collaborator shares in study development; provides funding, drug supply and distribution and data submission for regulatory approval (registration trials)

AFT responsible for AFT site selection and site performance monitoring, assists with patient recruitment efforts at minimum; other functions are per  agreement with collaborators

CRITERIA

Overall good standing as Alliance member

AFT reviews previous site performance and accrual reports to determine site selection in general

AFT conducts feasibility process to assess site’s capability to conduct trial based on specific protocol requirements

AFT invites site to participate

                                     AFT

                                     ALLIANCE

Study Selection and Development

Study design by Alliance scientific and modality committees

Study design by Alliance scientific and modality committees

Studies available by invitation

Studies available through CTSU menu

Studies open to invited sites

Studies open to Alliance and NCTN members

Site Selection

Studies limited to selected sites with network

Generally, studies open to all components of network

# of sites limited based on study and funding

# of sites within member network may be limited; entire network, including affiliates may not be invited

Operations Systems and Partners

Separate Interactive Response Technology (IRT for patient registration), Clinical Trial Management System (CTMS), AFT Medidata RAVE electronic data capture, Argus Safety System (expedited adverse event reporting), electronic Trial Master File (eTMF), AFT Biospecimen Management System

• CTSU Oncology Patient Enrollment
• Alliance Medidata Rave electronic data capture
• CTSU Regulatory Support System
• Alliance BioMS (biospecimen management system)

Central Institutional Board Review (CIRB) (Quorum or other CIRB)

• NCI Central Institutional Board Review (CIRB)

Mayo Clinic Statistics and Data Center

• Mayo Clinic Statistics and Data Center

Biorepository at Washington University

TBD

• Biorepositories at Washington University, Mayo Clinic, Ohio State University

Contracts and Funding

Master Services Agreement or Clinical Trial Agreement

• Agreements through Brigham and Women’s Hospital
• Purchasing Service Agreement (PSA) allows per case funding from NCTN grants
• Agreements with Mayo Clinic allows per case funding through NCORP grants

Negotiated budget (study, patient case reimbursement, administrative site costs)

• Standard NCI per case payment, and additionalpayments per study funding sheet

Per case payment for patients and accrual and pass through costs

• Agreements with Mayo Clinic – case reimbursements through NCORP grants

Alliance Membership Accrual

One patient intervention accrual credit toward Alliance membership recorded after network has met 15 patient treatment/intervention accruals per year (cannot use AFT accruals to make up Alliance deficiency – e.g., 15 Alliance accruals + 10 AFT accruals = 25 Alliance membership accruals; however, 10 Alliance accruals + 10 AFT accruals = 10 Alliance membership accruals)

• 15 patient treatment/intervention accruals per  network/per year
• 5 patient treatment/intervention accruals per affiliate/per year