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    Institutional Review Board (IRB) - Medical Record, Chart Review, or Computer Database

    Printer-friendly verson: Medical Record, Chart Review, or Computer Database (MSWord 98KB)
    If you have problems using the Word document listed above, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, 5th Floor, P-Campus,
    San Francisco, CA 94115

    For questions and help, please call:
    Leigh Pruneau, PhD, RN, CIP.
    Human Research Protection Program Administrator
    at (415) 600-3688.

    Provide the following information for the Medical Record, Chart Review, or Computer Database Form

    • Title of Project:
    • Principal Investigator's name: 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:
      • Department:
      • Mailing Address:
      • Phone Number:
      • Fax Number:
      • 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 and E-mail address
    1. What type of record/chart/database will be reviewed for research? Please check as appropriate:
      • Medical Record/Chart Review
      • Films/X-rays/Other Images
      • Computer/Database
      • CPMC administrative /billing records
      • Quality Improvement Records
      • Other types of record (please specify):
    2. Are you receiving funding from any source to perform this research? Yes/No
      If yes, who is providing the funds?
    3. List all names of individual(s) who will be responsible for querying medical records/ charts and/ or database, indicate whether CPMC medical staff or employee, and role with the study or project.
    4. List all names of Individual(s) who will be given access to the data, indicate whether CPMC medical staff or employee, and role with the study or project.
    5. Purpose of the study (describe briefly).
    6. How many records will be reviewed?
    7. Will data be sent outside of CPMC? Yes/No
      If no, please note that subsequent release of data outside of CPMC requires approval by the IRB. Investigators will need to update their request.
      • If yes, where will data be sent?
      • Why is it necessary to send data outside of CPMC?
      • How will data be sent? Please describe actual methods and include plans for coding and/ or encryption).
    8. Data to be obtained for the time period of: (From Date: and To Date: ):
    9. If database(s) are to be queried, please specify.
      • Not using database(s)
      • Departmental databases/registries, specify:
      • Financial/billing database

      • Other, please specify:
    10. If record(s)/chart(s) to be queried, please specify.
      • Not using record(s)/ chart(s)
      • Hospital medical records
      • Other, please specify:
    11. Data to be used for:
      • Publication
      • Oral presentation
      • Other, please specify:
    12. Please check all categories of data that will be obtained during the record/ database review?
      • Demographics (age, sex, address)
      • Drug/Device utilized
      • Diagnosis

      • Length of Stay
      • Lab values
      • Location of service (OR, ED, inpatient, outpatient)
      • Radiology testing
      • Clinic Notes

      • Procedures/Treatment
      • Provider of record (who saw pt, signed d/ c note)
      • Billing/ Charges
      • Other, please specify:

    Principal Investigator's statement and acknowledgement that the information provided above is complete and correct

    I assure that the information I obtain as part of this research (including protected health information) will not be reuse or disclosed to any other person or entity other than those listed on this form, except as required by law or for authorized oversight of the research project. If at any time I want to reuse this information for other purposes or disclose the information to other individuals or entity, I will seek approval by CPMC IRB.

    Principal Investigator should provide signature/date