UNC Health Care Carolina Data Warehouse for Health

UNC Health Care – Carolina Data Warehouse for Health Project Review Request

Please complete all information requested to the best of your ability. If project does not require IRB, please attach a detailed description of the proposed project in lieu of IRB application.

Monthly Deadline for submission: Last Friday of the month in order to be considered for approval at the following month’s Operations Committee Meeting.

Date of request: Click here to enter a date.

Requester Information Requester Name: Role: ☐ Undergraduate student ☐ Graduate student Position/Title: ☐ Medical student ☐ Resident ☐ Fellow ☐ Faculty ☐ Other: Department/Division/Center:Click here to enter text. Internal Mailing Address:Click here to enter text. Email:Click here to enter text. Phone:Click here to enter text. Faculty Advisor (if applicable):Click here to enter text. Principal Investigator (PI): Click here to enter text. (if different from requestor) PI Position/Title:Click here to enter text.

Project Information Project Title: Click here to enter text. Project Type: ☐ Research ☐ QI ☐ Clinical Operations IRB Number: IRB Status:

☐ Not submitted ☐ Submitted ☐ Approved

☐ Exemption approved by IRB ☐ NHSR determined by IRB General Subject Area (e.g., Cancer, Click here to enter text. Diabetes): Summary Description of Project: Click here to enter text.

CDW-H Data Request Details (for complex requirements, please attach a separate sheet) Summary of CDW-H Data Request Click here to enter text. Needs:

UNCHCS Version 20130801 Page 1 of 4 Date Range for Data: Click here to enter text.

Type of Data Requested: Purpose of Data Request:

☐ De-identified ☐ Identification of potential subjects for recruitment ☐ Limited Data Set ☐ Under limited HIPAA waiver ☐ As Consented Subjects

☐ PHI ☐ IRB-approved retrospective data collection (*see definitions at the end of this document if unclear) ☐ Other (describe): Specific Data Elements Requested e.g., Click here to enter text. names, MRN, DOB, age, inclusion and exclusion criteria, lab tests, procedures, diagnosis (please provide diagnosis codes and/or CPT codes if applicable): List All Users Requiring Access to Data Click here to enter text. (names/roles – must also be listed on the IRB as having access to the data): Will this data or derivatives of it be Click here to enter text. shared with anyone outside of UNC? (Please specify what data will be shared and the recipient) Project requires chart review following receipt of data? ☐ Yes ☐ No Requested Data Frequency: ☐ One-time

☐ Recurring: ☐ Monthly ☐ Quarterly ☐ Annually ☐ Other: End date: Click here to enter a date. Please indicate how long you require for Data will be archived: analysis of the data set: ☐ 3 Months ☐ 6 Months ☐ 9 Months ☐ 1 Year

Note: IRB approval must be current ☐ Other time period: throughout this time period after (the last instance of, if recurring) the data set is provided Please indicate any hard deadlines for Click here to enter text. delivery of dataset and reason for deadline (i.e., deadlines for manuscript submission, patient enrollment deadlines):

Funding Details Is project funded? ☐ Yes ☐ No If project is funded: Funding Source: Click here to enter text. Total Funding Amount: Click here to enter text. UNCHCS Version 20130801 Page 2 of 4 Total Funding Allocated to Support Click here to enter text. CDW-H : If project is not funded: Funding Pending? ☐ Yes ☐ No Plans for Future Funding: Click here to enter text.

* Data Set Definitions:

Limited Data Set:

A limited data set may not include any of the following direct identifiers of the individual or of the individual’s relatives, employers, or household members:

• Names • Any geocodes that identify an individual household such as street address • Telephone numbers • Fax numbers • Electronic mail addresses • Social security numbers • Medical record numbers • Health plan beneficiary identifiers • Account numbers • Certificate/license numbers • Vehicle identifiers and serial numbers, including license plate numbers • Device identifiers and serial numbers • Web universal resource locators (URL) • Internet protocol (IP) address numbers • Biometric identifiers, including finger and voice prints • Full face photographic images

Note: a Limited Data set may include: • All elements of dates directly related to an individual, including birth date, admission date, discharge date, dates of health care procedures or other services, and date of death. • Geocodes above the level that would identify an individual household such as State, county, city, town, census track, precinct, zip code.

De-identified Data Set:

A deidentifed data set may not include any of the following direct identifiers of the individual or of the individual’s relatives, employers, or household members:

• Names • Geographic subdivisions smaller than a state

UNCHCS Version 20130801 Page 3 of 4 • Zip codes • All elements of dates except year directly related to an individual, including birth or death or dates of health care services or health care claims

• Telephone numbers • Fax numbers • Electronic mail addresses • Social security numbers • Medical record numbers • Health plan beneficiary identifiers • Account numbers • Certificate/license numbers • Vehicle identifiers and serial numbers, including license plate numbers • Device identifiers and serial numbers • Web universal resource locators (URL) • Internet protocol (IP) address numbers • Biometric identifiers, including finger and voice prints • Full face photographic images • Any other number, characteristic or code that could be used by the researcher to identify the individual

Note: Although a de-identified data set cannot contain a birth date, it may contain the individual’s age expressed in years, months, days, or hours, as appropriate, except for individuals who are aged 90 years or more. For persons aged 90 years and above, the age in a de-identified data set can only be stated as being within the category of age 90 or above.

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