ACRIN PA 4002 Site Activation Checklist

A. REGULATORY (Fax all information to the Regulatory Department: 215-717-0936)

IRB Approval Letter (June 8, 2007 protocol)

IRB Approved, Site-Specific Informed Consent Form (June 8, 2007 protocol)

IRB Correspondence, if appropriate

OHRP Federal Wide Assurance (FWA)

B. ADMINISTRATIVE (Fax all necessary information to PA 4002 Project Manager: 215-717-0936)

Required Application Approvals:

ACRIN General Qualifying Application (if not already an approved general ACRIN site)

ACRIN PA 4002 Protocol Specific Application (PSA)

Required Contract:

Executed ACRINPA 4002 Institution Agreement (2007-2009)

Executed ACRIN PA 4002 Case Reimbursement Schedule (2007 Budget Amendment to ACRIN Institution Agreement)

C. PERSONNEL (Fax all necessary information to ACRIN PA 4002 Project Manager: 215-717-0936)

Principal Investigator

Name:

Human Subject/ Ethics Education Certificate

Obtain an ACRIN Reader ID number via the ACRIN Username Request Form

Statement of Investigator and Curriculum Vitae

Primary Medical Oncologist

Name:

Human Subject/ Ethics Education Certificate

Obtain an ACRIN Reader ID number via the ACRIN Username Request Form

ACRIN Research Associate/Coordinator

Name:

Human Subject/ Ethics Education Certificate

Obtain an ACRIN web password for registration and data entry via the ACRIN Username Request Form (http://www.acrin.org/pdf_file2.html?file=password.pdf)

Oncology RN/Coordinator

Name:

Human Subject/ Ethics Education Certificate

Obtain an ACRIN web password for registration and data entry via the ACRIN Username Request Form (http://www.acrin.org/pdf_file2.html?file=password.pdf)

Request Form (http://www.acrin.org/pdf_file2.html?file=password.pdf)

Lead MR Technologist

Name:

Human Subject/ Ethics Education Certificate

Obtain an ACRIN web password for registration and data entry via the ACRIN Username Request Form (http://www.acrin.org/pdf_file2.html?file=password.pdf)

D. INFORMATICS

Computer to be used for image transfer on site network & capability to connect to Internet running Windows 2000 Pro or XP Pro (ACRIN provides software for electronic image transfer. Review protocol section 11.0 of the protocol document.)

Internet browser Internet Explorer 6.0 or Netscape Communicator 6.0

E. IMAGING (For questions, please contact the Image Management Center:)

Note: All credentialing of site equipment needs to be completed prior to recruitment/accrual to

the trial.

MR Requirements:

1.5T Siemens, GE, or Philips scanner

Multi-coil torso array or other coil suitable for abdominal MRI

Minimum gradient strength of 33 mT/m and slew rate of 120 T/ms

Capability to submit MR test subject studies and uniform phantom images in DICOM format on Magneto-Optical Disk (MOD), Compact Disc (CD) or via the internet – File Transfer Protocol (FTP)

Phantom and test subject images approval.

ACRIN PA 4002 Site Start-Up Checklist Page 1 of 2