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Rady Children’s Hospital-San Diego (RCHSD)

Record / Chart Review / Computer Database Research Study

**USE THIS FORM ONLY IF YOUR SUBMISSION IS A RETROSPECTIVE OR PROSPECTIVE RECORD/CHART REVIEW, CASE REPORT AND OTHER COMPUTER DATABASE RESEARCH STUDY

Instructions for submitting on paper
1.  This form must be accompanied your IRB application and other required documents associated with the project.
2.  The Principal Investigator must sign where indicated on the last page.

Section 1a: PROJECT TITLE*

*For sponsored projects include sponsor’s project identifier and version number.

Section 1b: Principal Investigator

/
Yes / No /
SECTION 2: TYPE OF RECORD/CAHRT/DATABSE THAT WILL BE REVIEWED FOR RESEARCH
Medical Record/Chart Review
Will the review involve more than one patient
Quality Improvement Records
Hospital administrative/billing records
Films/Xrays
Computer/Database (if different from other categories listed in this Section 2)
Trauma database
Will data and/ or specimen be sent outside of RCHSD. If so, is there any data transfer agreement and/or material transfer agreement in place?
OTHER TYPES OF RECORD(Specify)
Total projected records to be reviewed

Section 3: PROJECT INFORMATION

1. Individual(s) who will be responsible for querying medical records/charts and/or database. (This must be a RADY CHILDREN’S EMPLOYEES, PHYSICIANS ON THE MEDICAL STAFF)

2. Please list the names of all individuals who will be given access to the data.

3. Time period of the data to be obtained:______

(This refers to the data itself, not the time period over which you are collecting it.)

4. Specify the database(s) to be queried if applicable:

5. Specify the record(s)/ chart(s) to be queried, if applicable:

- Hospital Records

- Departmental records

- Other______

6. Data to be used for:

- Publication

- Oral presentation for educational purpose

- Oral presentation for research purpose

- Other______

7.  The following information is considered identifiable under the Privacy Rule regulations. Please check off whether any of the following will be obtained.

YES NO Patient/Subject Name

Address street location

Address town or city

Address state

Address zip code

Elements of Dates (except year) related to an individual. For example, date of birth, admission or discharge

dates, date of death

Telephone number

Fax Number

Electronic mail (email) address

Social security number

Medical record numbers

Health plan beneficiary numbers

Account numbers

Certificate/license numbers

Vehicle identification numbers and serial numbers including license plates

Medical device identifiers and serial numbers

Web URLs

Internet protocol (IP) address

Biometric identifiers (finger and voice prints)

Full face photographic images

Any unique identifying number, characteristic code

Link to identifier (code)

If any of these elements are checked off, the data cannot be considered de-identified and authorization from the subject or a waiver of HIPAA authorization from the IRB is required.

8.  If links to identifiers are used, please describe the coding mechanism to be used.

9.  Pursuant to the RCHSD confidentiality policy, anyone who is not an RCHSD employee, a physician on the medical staff, and a RCHSD GME approved trainee (e.g., residents, fellows, and students) must sign the confidentiality acknowledgement to access the patient protected health information. Please contact Health Information Department for more information at 858-966-4095.

Section 4: Signature

Principal
Investigator / Date:

Version 08/2008