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    Institutional Review Board (IRB)
    Full Committee Review Form

    MS Word Version: Full Committee Review Form

    If you have problems using the Word document, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, Suite 514,
    San Francisco, CA 94115

    For questions and help, please call:
    Human Research Protection Program at (415) 600-3688.

    Form Information

    • Title of Project:

    • Principal Investigator:
      * The Principal Investigator must be a medical staff member or an employee of CPMC. He or she is considered the responsible party for legal and ethical performance of the project.

      • Sutter Affiliation:

      • Dept.:

      • Mailing Address:

      • Phone Number:

      • Fax No:

      • E-mail address:

      • ** If you wish to designate a contact other than the PI to receive correspondence regarding this IRB submission, please include their information.
        • Name of Contact:
        • Contact Phone Number:
        • Contact E-mail address:

    • Sub-INVESTIGATOR (S):

      • Name:

      • Affiliation:

      • Dept.:

    • Anticipated Project Period: (include From Date, and To Date)

    • Total Expected Enrollment Number at this Site:

    • Recruitment Source (s):

    • Subject Payment:

    • Funding agency or sponsor:

    • COSTS: Who will be responsible for costs beyond standard patient care? Check all that apply.

      • Subject

      • Study Sponsor

      • Third Party Insurance

      • Other:

    • Estimated Extent of Potential Financial Liability to Patient as a Result of Participation in this Study: (dollar amount)


    Check affiliate site where research will be conducted:
    Greater Bay Area:

    • Alta Bates Summit Medical Center, Berkeley & Oakland

    • California Pacific Medical Center, San Francisco

    • Eden Medical Center, Castro Valley

    • Marin General Hospital, Greenbrae

    • Mills-Peninsula Health Services, Burlingame/San Mateo

    • Novato Community Hospital, Novato

    • Palo Alto Medical Foundation, Palo Alto

    • Santa Cruz Medical Foundation

    • St. Luke's Hospital, San Francisco

    • Sutter Delta Medical Center, Antioch

    • Sutter Maternity & Surgery Center of Santa Cruz

    • Sutter Medical Center of Santa Rosa

    • Sutter Regional Medical Foundation

    • Sutter Santa Cruz

    • Sutter Solano Medical Center, Vallejo

    • Sutter Tracy Community Hospital, Tracy

    Greater Sacramento Valley/Foothills:
    • Sutter Amador Hospital, Jackson

    • Sutter Auburn Faith Hospital, Auburn

    • Sutter Davis Hospital, Davis

    • Sutter Medical Center, Sacramento

    • Sutter North Medical Foundation, Marysville/Yuba City

    • Sutter Roseville Medical Center, Roseville

    Central Valley:
    • Memorial Hospital, Los Banos

    • Memorial Medical Center, Modesto

    • Sutter Gould Medical Foundation, Modesto

    North Coast:
    • Sutter Coast Hospital, Crescent City

    Clearlake:
    • Sutter Lakeside Hospital, Clearlake

    Other Sutter Affiliates:

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    Other Information

    Please provide answers to:

    1. Is the research study open to any of the following Special Subject Populations?

    2. Yes/No (If Yes, indicate all that apply):
      • Children (below 18)

      • Cognitively or psychologically impaired

      • Fetuses

      • HIV/AIDS patients

      • Human in vitro fertilization

      • Pregnant women

      • Terminally ill (Deteriorating from a life-threatening disease or condition for which no effective standard treatment exists)

      • Comatose

      • Prisoners

      • Non-English speaking

      • Students or staff

      • Other

    3. Will investigational drugs be used?
      Yes/No. If Yes, provide FDA IND number

    4. Will an approved drug be used for an unapproved use (off label)?
      Yes/No. If Yes, provide FDA IND number

    5. Will investigational devices be used?
      Yes/No. If Yes, provide FDA IND number
      If yes, is the device: Category A or Category B or Non-significant risk

    6. Will an approved device be used for an unapproved use (off label)?
      Yes/No. If Yes, provide FDA IND number ;or indicate that Non-significant risk

    7. Will radioactive materials be used in this study?
      Yes/No. If Yes, approval of the Radiation Safety Committee Department Chair is required.


    8. Radiation Safety Committee Approval
      As Chairman of the Department, I have reviewed the attached protocol and agree to support its implementation by providing name/signature/date.
      Radiation Safety Committee Department Chair’s Signature:
      Date:
    9. Tissue/Blood Banking: Will tissue or serum samples be sent outside of the institution?
      Yes/No.

    10. Does the research protocol involve questionnaire(s)?
      Yes/No. If Yes, please submit questionnaire(s).

    11. Do questionnaires involve special sensitivity (e.g., drugs/alcohol abuse; sexual behavior)?
      Yes/No. If Yes, please submit questionnaire(s).

    12. Will any advertising (print ads, radio, television, or Internet) be used to recruit study subjects?
      Yes/No. If Yes, please submit recruitment materials.

    13. Conflict of Interest (COI): Have all CPMC Investigators listed on this application completed the COI form for the current year?
      Yes/No. If No, please submit the COI form with this application. A copy of the form can be requested by sending an email to coi@cpmcri.org

    14. Education of Human Subject Protection:
      Have all CPMC Investigators listed on this application taken a course about Human Subject Protections or Responsible Conduct of Research?
      Yes/No. If No, please refer to “List of Training Options in Human Subjects Protections”, “IRB Submission Requirements Checklist” or please contact the IRB Office at (415)600-3686 or 600-1477.

      Have the research staff (s) taken the same course?
      Yes/No. If No, please refer to “List of Training Options in Human Subjects Protections”, “IRB Submission Requirements Checklist” or please contact the IRB Office at (415)600-3686 or 600-1477.

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    Administrative Acknowledgement of the Protocol

    My signature acknowledges that I have reviewed the attached protocol and agree to support its implementation by providing name/signature/date.
    Principal Investigator’s Department Chair’s Signature:
    Date:

    Principal Investigator’s Certification and Assurance
    My signature below constitutes my certification and assurance that:

    1. I certify that the information provided in this application is complete and correct.

    2. I understand that as Principal Investigator, I have ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the CPMC IRB.

    3. The consent form will adequately inform the subjects of the nature, scope, and consequences of their participation in the project.

    4. I will adhere to the research protocol as submitted, unless approval for change is granted in advance by CPMC IRB.

    5. I will notify CPMC IRB within 5 working days of any deaths or serious injuries associated with the conduct of the experiment, any unanticipated problems and adverse reactions, and/or any deviations from the protocol.

    6. Appropriate records, including consent forms will be maintained and be available to the CPMC IRB upon request.

    7. I will report on the progress of the study at intervals required by CPMC IRB (at least once per year).

    8. I have disclosed all financial interests that I, the Co-Investigators, Sub-Investigator(s), or any close family members may have in the study sponsor or competing companies, or any benefits that I/we will receive from my participation in this study.

    9. I will adhere to Good Clinical Practice (GCP) and all applicable governmental regulations.

    10. I understand that failure to adhere to these policies and procedures is unlawful and unethical, and that any such action may result in no legal protection from my institution.

    11. I understand that CPMC IRB approval does not indicate institutional authorization to conduct this research study. I will obtain appropriate approval from all institutions involved in this research project.

    12. I understand if I will be unavailable to direct this research personally, I will assure that coverage is available in my absence. Either this person is named as a co-investigator in this application, or I will advise CPMC IRB by letter, in advance of such arrangements.

    Principal Investigator’s Signature:
    Date:

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    Study Contact Information

    The institutional Review Board (IRB) is always looking for ways to promote better communication between our staff and yours. Therefore, we would like to make sure our contact information for your office is as current as possible. Please fill out this form, and anytime thereafter, to report any changes in your contact information.
    Thanks you.

    Please type in the following information:

    • Name of PI

    • Department

    • Address

    • PI’s phone

    • PI’s fax

    • PI’s e-mail

    If you wish to designate a regulatory contact in addition to the PI, please list his/hers information below:
    • Name of Regulatory contact

    • Regulatory contact’s phone

    • Regulatory contact’s fax

    • Regulatory contact’s e-mail

    • Additional comments

    If you wish to designate a clinical coordinator contact in addition to the PI, please list his/hers information below:
    • Name of Clinical coordinator contact

    • Clinical coordinator contact’s phone

    • Clinical coordinator contact’s fax

    • Clinical coordinator contact’s e-mail

    • Additional comments

    • Date prepared

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