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New Study Information Checklist

New Study Information Checklist

Section I – Business Development Input

Protocol Name/Number:___ARAMIS: a multinational, randomised, double-blind, placebo-controlled, Phase III efficacy and safety study of ODM-201 in men with high-risk non-metastatic castration-resistant prostate cancer BAY 1841788 / 17712 Protocol Version: 3.0 19Jul16

Sponsor Name/Contact:______Bayer______

CRO Name/Contact:__ICON Sarah Hooper, Clinical Trial ManagerCell:+1 978-760-3656 Email:

Central IRB:______QUORUM, can use our preferred______

Anticipated Enrollment Completion Date: ___Summer 2017_(probably longer as took more than two years to get half of their enrollment and they have half to go)______NCT #: _NCT02200614

Total per site # of Anticipated Enrollment: _1 per month______(Dr. Haluschak has about 105 nmCRPC patients in EHR)

Date Submitted to HIRC: ____ Teresa Evanoff, the lead CRC, will complete ______

Principal Investigator:

  • Name:______John Haluschak (Has reviewed full protocol)
  • 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.
  • 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:__Dayton Physicians offices at Good Samaritan North and Greater Dayton Cancer Center

Sub-Investigators: List EachSub-I Below.

Sub-I #1 ______Shamim Jilani, MD______

  • Email Address for trial correspondence: ______
  • Years of clinical trials experience__15__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: ______Dayton Physicians offices at Good Samaritan North and Greater Dayton Cancer Center___

Sub-I #2 Nkeiru Okoye, MD

  • Email Address for trial correspondence: ______
  • Years of clinical trials experience__1___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.
  • Site Investigator will be seeing patients: ___Dayton Physician offices at Atrium and Greater Dayton Cancer Center _

Sub-I #3 ______NA______

  • 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 HospitalMiami Valley Hospital

One Medical Center Dr. 2222 Philadelphia Dr.One Wyoming Street
Middletown, Ohio 45005 Dayton, Ohio 45406 Dayton, OH 45409

Upper Valley Medical CenterGood Samaritan North Miami Valley Hospital - South

3130 N. County Rd. 25-A9000 North Main Street2400 Miami Valley Drive
Troy, Ohio 45373Dayton, Ohio 45415Dayton, OH 45459

Wright State Physicians Pulmonary & Critical Care Consultants

725 University Blvd.1520 South Main St.

Fairborn, OH 45324Dayton, OH 45409

If Not Listed Above:

  • Name of Facility ___Will eventually conduct trial in four Dayton Physician locations (Good Samaritan North, Miami Valley South, Greater Dayton Cancer Center, Atrium)
  • Address __This information has been provided for all Dayton Physician Locations
  • 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: We will add new Sub-Is as they complete their CITI training. When Sub-Is are added that see patients at Miami Valley South, we will begin to conduct the trial at this location.

______

______

Section II - Research Manager Input

Lead Coordinator Assigned: (prior to pre-site visit) ______Teresa Evanoff______

Total per site anticipated Screen Failures:______

If Subjects are Compensated, when: ______TotalAmount: ______

Billing/Invoicing/Budget Information:

  • Company Name:______
  • Attention To:______
  • Address:______
  • Telephone:______
  • Email:______
  • Special Instructions:______

______

  • Advertising Provision Amount: ______

List all research coordinators working on this study:

Teresa Evanoff Angie Shoen Ellen Cato

List additional individuals to be added to the Delegation of Duties Log:

  • List role associated with each individual ______

______

______

______

Check Alllaboratories (including addresses) which will be used:

AMC, One Medical Center Drive, MiddletownCompuNet, 2309 Sandridge Drive, Moraine

MVH, One Wyoming Street, DaytonOther ______

MVHS, 2400 Miami Valley Drive, Centerville

Research Manager Comments: ______

______

______

______

Questions, please contact Rachel Smith, Regulatory Specialist at

Upon completion, please forward to:

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