ACRIN PA 4008 Site Activation Checklist
Thank you for your interest and support of the ACRIN PA 4008 Trial. Please use this checklist to ensure that all necessary materials have been submitted prior to participation. The protocol documents, imaging requirements, contact personnel, recruitment materials and other resources are available on the ACRIN website (www.acrin.org). Select Protocol Summary Table and scroll down to ACRIN PA 4008 in the Cardiovascular Trial listing.
A. REGULATORY (E-mail IRB approval letter for the following materials along with approved ICF to Patty Blair at or fax to the regulatory department: 215-717-0936)
IRB Approval Letter for Protocol
IRB-Approved Informed Consent Form
IRB Correspondence, if appropriate
IRB Membership List and Federal Wide Assurance (FWA) documentation
B. ADMINISTRATIVE (E-mail materialsCynthia Olson ()
Application:
ACRIN PA 4008 Protocol Specific Application (PSA)
Curriculum Vitae (CV) of the principal investigator listed on the PSA
Required Contract:
ACRIN PA 4008 Institutional Agreement
ACRIN PA 4008 Case Reimbursement Schedule (part of Article IV of the Institutional Agreement)
C. PERSONNEL (E-mail (preferred) to Cynthia Olson or fax to ACRIN PA 4008 Project Support: 215-717-0936, )
Principal Investigator:
Completed ACRIN Statement of Investigator form, specific to the ACRIN PA 4008 trial signed by the Principal Investigator
Human Subject Protection Certificate (either institution’s own training program or the http://phrp.nihtraining.com/users/login.php)
Radiologist/Cardiologist:
Obtain an ACRIN Reader ID: Radiologists or cardiologists who will provide data for imaging-related case report forms must obtain an ACRIN Login & Password and Reader ID request by registering on line at User Registration for Web-based Data Entry.
Human Subject Protection Certificate (either institution’s own training program, CITI, or the http://phrp.nihtraining.com/users/login.php) *
Site Research Associate/Coordinator:
Human Subject Protection Certificate (either institution’s own or the http://phrp.nihtraining.com/users/login.php)
Obtain an ACRIN web password for registration and data entry. All site study related personnel should request an individual Login Name and Password if they will be registering patients or entering accrued patient data on the ACRIN website. A Reader ID should be obtained for all physicians interpreting study related images. The ACRIN Login Name and Password should not be shared with other study site personnel. An ACRIN Login Name and Password or Reader ID can be obtained using the link below: User Registration for Web-based Data Entry.
Lead MR Technologist:
Human Subject Protection Certificate (either institution’s own or the NIH cancer.gov course) *
* Please note that ACRIN does not collect the HSP certificates for these personnel but requires sites to keep in the regulatory binder for their records.
D. SITE EXPERIENCE
Site has at least minimal experience with arterial tonometry equipment in clinical research and is able to submit sample tests acquired by tonometry as outlined in the protocol specific application
E. IMAGING REQUIREMENTS
Note: Site equipment qualifications must be completed before your site may begin recruiting for this trial.
CTA and SPECT Modality Requirements:
Submission of one (1) test MR case prior to opening to enrollment accompanied by an ITW form (image transmittal worksheet) which can be found at the ACRIN website: www.acrin.org and by accessing the ACRIN PA 4008 link.
All readers must meet the qualifications outlined in the protocol specific application
F. COMPUTER HARDWARE AND SOFWARE
Computer to be used for image transfer (ACRIN provides software for electronic image transfer, please reference protocol section 9.0 for more details or contact the Triad support desk at Triad-Support @acr.org or by phone at 215-940-8820.
Please contact the ACRIN TRIAD Help Desk to arrange the installation of the TRIAD Software prior to submission of the test images at Triad-Support @acr.org or by phone at 215-940-8820.
ACRIN Site Specific Checklist (2012) Page 1 of 2