Institutional Membership Application

Institutional Membership Application

<p> ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION</p><p>Your complete application package must include the following documents:</p><p>Cover Letter from the Principal Investigator of the Main Member (see instructions for additional information)</p><p>Completed Membership Application</p><p>Federalwide Assurance Application/Documentation </p><p>NIH Bio-Sketch/CV (for Principal Investigator only)</p><p>List of Investigators and Specialties</p><p>List of Affiliate Sites (if applicable)</p><p>Copy of Audit Reports and Corrective Action Plans</p><p>(If application is incomplete, it will not be submitted to the Membership Committee)</p><p>Revised June 14, 2012 1 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION</p><p>Membership Application Type: Main Affiliate</p><p>Institutional Information Legal Name of Institution: (Confirm the legal name with an institution official. This should match the NCI ID Code, if assigned)</p><p>Legal Address of Institution: </p><p>NCI Identification Code: </p><p>Name of Principal Investigator: Phone: E-Mail: Name of Co-Principal Investigator (required for main member): Phone: E-Mail: Name of Lead CRA: Phone: E-Mail: Name of Institutional Official (contact for legal agreements): Phone: E-Mail:</p><p>FWA and IRB Information Federalwide Assurance #: Expiration Date: (If you do not have an FWA #, this application will not be processed) Name and address of Institutional Review Board: </p><p>IRB Registration Code Number: Expiration Date: (Applications will be delayed until this information is provided, as this is a NIH requirement)</p><p>Funding Information Does a Community Clinical Oncology Program (CCOP) Grant currently fund your institution/group? Yes  No If “yes," indicate the grant number and funding period. Grant #: Funding Period: If you are applying for a CCOP grant, please indicate your application submission date (mm/dd/yy). </p><p>Revised June 14, 2012 2 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION</p><p>MEMBERSHIP PROPOSAL </p><p>1. Indicate the resources available to assure timely compliance with Group administrative and data requirements (please mark all that apply).</p><p>Role Number of Personnel Comments Investigators Clinical Research Associates/Professionals Oncology Nurses Regulatory Support Pharmacy Personnel</p><p>2. Have you participated in cancer research cooperative group trials? Yes No</p><p>If yes, . List the group(s):</p><p> Provide a copy of the most recent CTMB audit report(s). If applicable, please include the corresponding corrective action plan(s). </p><p> Provide the total number of cancer patients enrolled onto all cooperative group clinical trials per year. ______(3 year average)</p><p>3. Have you participated in non-cooperative group cancer research trials? Yes No</p><p>If yes, provide the number of cancer patients enrolled onto non-cooperative group clinical trials per year. ______(3 year average) </p><p>Revised June 14, 2012 3 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION</p><p>If you have not enrolled patients on cooperative group clinical trials, complete items 4 and 5. Provide the details for the disease (s) or committee (s) appropriate to your Institution.</p><p>4. Document adequate patient resources available for entry into clinical trials. List your annual caseload by hospital and by disease.</p><p>Breast Cancer GI GU Leukemia Lymphoma Myeloma Neurologic Respirator Control y </p><p>5. Indicate anticipated accrual by types of studies (by disease or committee). You may wish to consult a recent studies list, which shows the current studies by committee, so you can make accurate accrual projections. This list is on the Alliance web page or available upon request.</p><p>Breast Cancer GI GU Leukemia Lymphoma Myeloma Neurologic Respiratory Control</p><p>Specify any disease areas (or committees) of Alliance research in which you do NOT foresee participation.</p><p>Revised June 14, 2012 4 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION</p><p>MEMBERSHIP PROPOSAL INSTITUTIONAL MEMBERSHIP INVESTIGATOR ROSTER INFORMATION</p><p>Complete the table below for each Investigator to be included on your roster </p><p>Name Specialty Discipline </p><p>Revised June 14, 2012 5 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION</p><p>MEMBERSHIP PROPOSAL</p><p>AFFILIATE SITES</p><p>(For Main Member Applicants Only) List all sites that meet at least one of the following.  Direct receipt of agent from CTEP;  Enrollment or consent of patients;  Direct receipt of federal funds; and/or  Responsible for submission of data to the study sponsor or their designee</p><p>NCI Legal (Full) Name of Principal Co-principal Address (must match Code Affiliate Institution Investigator investigator (if address for NCI Code, (should match NCI ID applicable) if assigned) Code)</p><p>Submit a separate Alliance Membership Application and Cover Letter for each site listed.</p><p>Revised June 14, 2012 6 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY INSTITUTIONAL MEMBERSHIP APPLICATION</p><p>MEMBERSHIP PROPOSAL</p><p>Application submitted by on:</p><p>Signature of Proposed Principal Investigator date</p><p>Signature of Institution Official date</p><p>Return Completed Application to: Membership Manager Marcia Kelly 230 W. Monroe Street Suite 2050 Chicago, IL 60606 [email protected] 773-834-7676</p><p>Revised June 14, 2012 7</p>

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