New Study Information Checklist

New Study Information Checklist Section I – Business Development Input

Protocol Name/Number: _____ POLARIS: Palbociclib (IBRANCE®) in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional Study (NIS)____ (A5481082)______Sponsor Name/Contact: ______Pfizer______CRO Name/Contact: CPI Global_____ Silvina Wills: Phone 609.720.1152 ext 112/[email protected] Kimberly Aguilar: [email protected] ______Central IRB: ______Schulman______Anticipated Enrollment Completion Date: _ Study duration will be approximately 5 years, assuming approximately 2 years of recruitment. It is expected the study to start enrollment by the end of 2016. NCT #: ______

Total per site # of Anticipated Enrollment: 15 subjects Date Submitted to HIRC: ______When CITI training is done______Principal Investigator:  Name: ______Shamim Z. Jilani, MD, FACP  Email Address for trial correspondence: __937-832-8803 ext 2032 [email protected]___ Operations Manager can also reach her: James [email protected]______ Years of clinical research experience __21___Years  CITI training, if not affiliated with WSU, please provide documentation (Modules required - BIO/COI/GCP) Yes No  If no CITI training, investigator has been informed that the study cannot move forward until CITI has been completed. Yes  Has this site and/or any investigator associated with this study been audited by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Health Products and Food Branch Inspectorate (HPFB) or Environmental Protection Agency (EPA) within the last five (5) years? Yes No  All sites where Investigator will see subjects:__ _Good Samaritan North Dayton Physicians Cancer Center_____

Sub-Investigators: List Each Sub-I Below. Sub-I #1 ______Nkeiru Okoye, MD  Email Address for trial correspondence: [email protected]______ Years of clinical trials experience __1-4_Years  CITI training, if not affiliated with WSU, please provide documentation (Modules required - BIO/COI/GCP) Yes No  If no CITI training, investigator has been informed that the study cannot move forward until CITI has been completed. Yes 2New Study Information Checklist  All sites where Investigator will see subjects: ____Atrium______Sub-I #2 Mark A Marinella, MD, FACP ______ Email Address for trial correspondence: [email protected]______ Years of clinical trials experience ______Years  CITI training, if not affiliated with WSU, please provide documentation (Modules required - BIO/COI/GCP) Yes No  If no CITI training, investigator has been informed that the study cannot move forward until CITI has been completed. Yes  Site Investigator will be seeing patients: __Good Samaritan North, Miami Valley South ______Sub-I #3 _____All oncology physicians at Dayton Physicians as they get their CITI training done ______ Email Address for trial correspondence: ______ Years of clinical trials experience ______Years  CITI training, if not affiliated with WSU, please provide documentation (Modules required - BIO/COI/GCP) Yes No  If no CITI training, investigator has been informed that the study cannot move forward until CITI has been completed.  All sites where Investigator will see subjects: ______

Research Facilities Used For Study:

Atrium Medical Center Good Samaritan Hospital Miami Valley Hospital One Medical Center Dr. 2222 Philadelphia Dr. One Wyoming Street Middletown, Ohio 45005 Dayton, Ohio 45406 Dayton, OH 45409

Upper Valley Medical Center Good Samaritan North Miami Valley Hospital - South 3130 N. County Rd. 25-A 9000 North Main Street 2400 Miami Valley Drive Troy, Ohio 45373 Dayton, Ohio 45415 Dayton, OH 45459

Wright State Physicians Pulmonary & Critical Care Consultants 725 University Blvd. 1520 South Main St. Fairborn, OH 45324 Dayton, OH 45409 If Not Listed Above:  Name of Facility ______Good Samaritan North Health Center Dayton Physicians Office______ Other: Atrium Dayton Physicians office, Miami Valley South Dayton Physicians office, Greater Dayton Cancer Center

Business Development Comments: Info on the 4 locations provided with Haluschak NSF CO30385______Section II - Research Manager Input 2 Rev 20160203 3New Study Information Checklist Lead Coordinator Assigned: (prior to pre-site visit) ______Total per site anticipated Screen Failures: ______

If Subjects are Compensated, when: ______Total Amount: ______Billing/Invoicing/Budget Information:  Company Name: ______ Attention To: ______ Address: ______ Telephone: ______ Email: ______ Special Instructions: ______ Advertising Provision Amount: ______

List all research coordinators working on this study: ______List additional individuals to be added to the Delegation of Duties Log:  List role associated with each individual ______

Check All laboratories (including addresses) which will be used:

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AMC, One Medical Center Drive, Middletown CompuNet, 2309 Sandridge Drive, Moraine

MVH, One Wyoming Street, Dayton Other ______

MVHS, 2400 Miami Valley Drive, Centerville

Research Manager Comments: ______

______

Questions, please contact Rachel Smith, Regulatory Specialist at [email protected] Upon completion, please forward to: [email protected]

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