New Study Information Checklist

New Study Information Checklist

Section I – Business Development Input

Protocol Name/Number: A PHASE III, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI−PD-L1 ANTIBODY) IN COMBINATION WITH ENZALUTAMIDE VERSUS ENZALUTAMIDE ALONE

IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AFTER FAILURE OF AN ANDROGEN SYNTHESIS INHIBITOR AND FAILURE OF, INELIGIBILITY FOR, OR REFUSAL OF A TAXANE REGIMEN

PROTOCOL NUMBER: CO39385

Sponsor Name/Contact: ______Hoffmann-La Roche

CRO Name/Contact: ____Genentech: Sherry Paulson cell: 650-922-5061

Central IRB: ______Copernicus ______

Anticipated Enrollment Completion Date: For ATEZ-Site activation is targeted from November 2016 to April 2017 and the recruitment period will have 17 months from December 2016 to April 2018. The total length of the study, from screening of the first patient to the end of the study, is projected to be approximately 42 months.

NCT #: ___They do not have one yet ____

Total per site # of Anticipated Enrollment Atezo-Screen=60 PTs/ Enroll= 33 PTs (From sponsor; Morerealistically, I might suggest 20 pts)

Date Submitted to HIRC:

Principal Investigator:

· Name: _John Haluschak______

· Email Address for trial correspondence: ______

· Years of clinical research experience __20+______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, Greater Dayton Cancer Center

Sub-Investigators: List Each Sub-I Below.

Sub-I #1 ______

· 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: ______

Sub-I #2 ______

· 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.

Sub-I #2 (continued)

· Site Investigator will be seeing patients: ______

Sub-I #3 ______

· 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 ______

· Address ______

· Departmental telephone number for subjects ______

· 24 hour phone number______

· BLS trained personnel Yes No N/A

· ACLS trained personnel & crash cart Yes No N/A

· Emergency drugs & supplies to stabilize

subject until emergency personnel arrive Yes No N/A

· Emergency response team within facility Yes No N/A

· Call 911 Yes No N/A

· Other______

Business Development Comments: ______Need to complete in 8 weeks for Dec SIV______

______

Section II - Research Manager Input

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:

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

Upon completion, please forward to:

Rev 20160203