General Qualifying Application

Section 1: Site Information

Name of Site:*

Street Address:

Street Address:

City, State, Zip Code:

* As it should appear on the ACRIN contract, website and database

Name of ACRIN Site Investigator* (Attach CV):

Street Address (if different than above):

Street Address:

Telephone Number:

Fax Number:

Email Address:

* The ACRIN Site Investigator is responsible for oversight of ACRIN activities at the institution; he/she may also function as a Principal Investigator on one or more ACRIN studies.

This application is for: (Check all that apply)

One hospital

One hospital with affiliated, freestanding facilities (clinics, imaging centers, etc.)

A multi-hospital system

A multi-hospital system with affiliated, freestanding sites (clinics, imaging centers, etc.)

One freestanding, non-hospital affiliated facility (clinic, imaging center, etc.)

More than one freestanding, non-hospital affiliated facility (clinics, imaging centers, etc.)

Site Accreditation:

In the table below, please list your site name and, if applicable, the names of all affiliated hospitals, facilities, clinics, etc. covered by this application.

Name of Site /Affiliated Facility
and address / JCAHO* Accreditation / Other Accreditation
(General Facility)
Yes No
Yes No
Yes No
Yes No
Yes No

* Joint Commission on Accreditation of Healthcare Organizations. For sites not JCAHO accredited, attach a “Site Quality Indicators” summary that includes a description of the site’s facility safety program, quality improvement program, and incident reporting procedures.

Comments (optional):

HIPAA Compliance:

Compliance with the requirements of the HIPAA Privacy and Security Rules for the handling of Protected Health Information (PHI) is a requirement for participation in ACRIN trials. In addition, sites must have a designated HIPAA Privacy Officer or federal compliance person.

Are all sites covered by this application HIPAA compliant? Yes No

If yes, please record the name(s) of compliance officer(s) or person(s):

If no, describe what actions will be put in place to become compliant with HIPAA rules and the associated timeline for achieving compliance:

Section 2: Personnel

Position Type / Number of FTE Staff / Certification or Equivalent / Number of Certified Staff
Diagnostic Radiologists / ABR
Nuclear Medicine Radiologists / ABNM
Physicists / ABMP
MRI Technologists / RT(MR)
CT Technologists / RT(CT)
PET Technologists / ARRT(N)
Research Associates and/or Data Managers / CCRP/ACRP
Other:

Is your site involved in training radiology residents? Yes No

If yes, record the number of residents:

Comments (optional):

Section 3: Technology Infrastructure

Do you have:

1.  Internet access? Yes [ Broadband / Dialup] No

2.  Browser: Internet Explorer 4.0 or Netscape 4.0 higher? Yes No

3.  Capability to view PDF documents? Yes No

4.  Technical support related to software installation and

image management? Yes No

Comments (optional):

Section 4: Equipment Inspection

Inspection/certification by state, city or local agencies for x-ray and other ionizing-radiation-producing equipment. (Attach copy of most recent report)

Agency

/ Frequency of Inspection

Comments (optional):

Section 5: Regulatory

Does your site have Federal-wide Assurance (FWA) approval as required by the Department of Health and Human Services and the Federal Drug Administration? Yes No

If yes, please provide your FWA number:

If no, please note that this approval is required to participate in ACRIN trials.

Visit: www.hhs.gov/ohrp/assurances for more information.

Does your site have an Institutional Review Board? Yes No

If no, please provide the name and address of an affiliate institution’s IRB or a commercial IRB that will provide this service for you:

Name of IRB:

Street Address:

Street Address:

City, State, Zip Code:

Comments (optional):

Section 6: Research Experience and Support

Please indicate prior research experience, if any, conducted at your site in the past five years by checking the relevant box(es) and indicating the research sponsor.

Single-institution retrospective research

Sponsored by Federal or state government

Sponsored by pharmaceutical or device company

Multi-center retrospective research

Sponsored by Federal or state government

Sponsored by pharmaceutical or device company

Single-institution prospective research

Sponsored by Federal or state government

Sponsored by pharmaceutical or device company

Multi-center prospective research

Sponsored by Federal or state government

Sponsored by pharmaceutical or device company

List site’s participation in research of other National Cancer Institute’s clinical trials cooperative groups:

(Check all that apply)

ACOSOG CALGB COG ECOG GOG NCCTG NSABP RTOG SWOG

Does your site have access to a tumor registry? Yes No

Research support available at your site: (Check all that apply)

Research contract support

Research budget development support

Public relations and participant recruitment support

List any unique features of your program of potential value to ACRIN:

Signature of ACRIN Site Investigator Date

Signature of Radiology Department Chair Date

Please forward entire application to:

or

ACRIN Administration

American College of Radiology Imaging Network

1818 Market Street, Suite 1600

Philadelphia, PA 19103

Phone: (215) 574-3240

ACRIN GQA Version: 05.04.07 Page 1 of 4