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tiE56XCebyIb5xpny4NPxMJmmhNaLgwI9XsfcdVJbaHsIY6eWERcFRoyPhCCKPpzzHbQCWtJFPsFLz7fzvbFbU94kbTx

UIC CCTS Data Request Authorization (DRA) Form

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Please make sure to first submit a Consultation Request via Research Ally. Once submitted, a Research Navigator will connect with you to schedule a meeting with the Biomedical Informatics Core. If you are requesting a data extract, Research Navigators will request that you fill out this Data Request Authorizatin (DRA) form prior to our meeting.

DRA Instructions: Please complete the UIC DRA form. This form is used to gather project requirements and collect the information necessary to accurately complete a data request. Please fill in all required and applicable fields. During our initial consultation, we will review the DRA and make any necessary modifications necessary before IRB submission.

Note: If needed, you will be given a return code to edit this page. Please select "Save & Return Later" to receive the return code.

The CCTS appreciates that any publications or presentations based on this work acknowledge CCTS support by referencing grant number UL1TR002003.

FAQ Sheet

Attachment:FAQ - CCTS CRDW UIC CIRCLE_Updated8.2023.pdf

CCTS Project ID:

Date of Request:

* must provide value

M-D-Y

Protocol or Project Title:

IRB Number:

Principal Investigator (PI) Name:

* must provide value

PI Email:

* must provide value

Requestor/Project Contact Name (If different than PI):

Requestor/Project Contact Email (If different than PI):

Identify dataset type requested (see "Explanation of Data Set Types" for more details):

* must provide value

Aggregate Counts (Dataset #1)

De-identified Data Set (Dataset #2)

Coded Data Set (Dataset #3)

Limited Data Set (Retrospective - Dataset #4a)

Limited Data Set (Prospective - Dataset #4b)

Identified Data for Subject Recruitment (Dataset #5)

Identified Data - Investigator Defined Group (Dataset #6)

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If you are ONLY requesting Aggregate Counts (dataset #1), an approved (IRB stamped) DRA form is not required.

Please provide inclusion and exclusion criteria including dates, ages, genders, procedure and/or diagnosis codes, etc. Other form fields can be left blank, as needed.

If you wish to also request clinical data extracts (dataset types #2-6), please complete a separate DRA form.

Are you interested in gaining access to QUICKSet?

QUICKSet is a self-service tool designed by the CCTS BI Core to help researchers obtain counts of clinical data for hypothesis generation and to determine study feasibility. Register for the required training here: CCTS Training

Yes

Already Have Access

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Explanation of Data Set Types

Attachment:Explanation of Data Set Types.pdf

Selection Criteria: Specify the inclusion and exclusion criteria - e.g. include a list of diagnoses and procedure names, diagnosis or procedure codes, and/or other specific parameters.

Note: ICD-9 codes should be provided for a date range prior to 10/1/2015, & ICD-10 codes should be provided for any date ranges that span past 10/1/2015

* must provide value

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What is the date range of data being requested?

Note: UIC CIRCLE currently has data from January 1, 2010 - present. Data from MaRS (Maternal Record System) spans from 2001-2015.

* must provide value

Specify age range. Please note whether the ages should be at the time of visit or current age.

* must provide value

Sex(es):

What is the maximum number of subjects approved?

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For Recruitment Lists, only - What is the maximum number of potential subjects you would like to receive in your recruitment list?

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If applicable, please describe how to handle cases where the result set is greater than the maximum number of subjects approved. (For example - only provide the most recently seen subjects, randomize subjects, etc.)

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Please specify the data elements/fields that you would like included in your result set.

Include explanations in the corresponding form fields that will appear after checking these boxes.

(Note: The inclusion and exclusion criteria provided above will be applied to the entire result set. Specify the data elements you wish to receive about subjects who meet the criteria.)

Patient demographics, please specify.*

Visit information (e.g. visit type: inpatient/outpatient/emergency, scheduling info), please specify.

Medications, please specify.

Vitals information (e.g. height, weight, BMI, temp, BP, heart rate, pulse, etc.), please specify.

Lab tests & dates, please specify.*

Lab results & dates, please specify.*

Diagnoses, please specify.

Procedure information, please specify.

Specific PHI/HIPAA Identifiers, please specify.**

Other, please explain.

Specify the patient demographics you would like included in your result set.

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Specify the visit information you would like included in your result set.

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Specify the medications you would like included in your result set.

Please explain any additional information you require related to medications - e.g. dose, route, frequency, etc.
Note: Only medication order information is available.

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Specify the vitals information you would like included in your result set.

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Please specify the lab test information you would like included in your result set:

If applicable, please specify specimen type.

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Please specify the lab result information you would like included in your result set.

If applicable, please specify specimen type.

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Please specify the diagnosis information that you would like included in your result set.

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Please specify what information related to procedures you would like included in your result set.

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**Please check all approved HIPAA Identifiers that you would like included in your result set. Please be aware that obtaining PHI requires IRB approval.

* must provide value

Names (First & Last)

Date of Birth

SSN (May not be available)

Email (May not be available)

Health Plan Beneficiary Number

Telephone Numbers

Street Address

City

State

ZIP Code

FIN (Financial Identification Number)

Any elements of dates (except year) directly related to an individual; Birth year of an individual who is 90 or elder

Any other unique identifying number, characteristic, or code (excluding unique codes assigned by a researcher)

Medical Record Number (MRN)

Fax Number (May not be available)

None/Not Applicable

**As needed, please further describe the specific PHI/HIPAA identifier(s) that you would like included in your result set.

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Please describe the "other" data fields requested.

Note: Please refer to the UIC CIRCLE FAQ sheet or contact the CCTS BI Core manager to ensure the type of data you are requesting is available.

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As needed, please provide any additional explanation of the requested data fields/result set.

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Describe the secure computing environment where the data will be stored:

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Please see the UIC CIRCLE FAQ sheet & table below to determine whether your request requires IRB approval.

If "yes", the CCTS Biomedical Informatics Core Data Request Manager will review your DRA form & protocol and email you a PDF copy to submit to the IRB (via UIC Research) along with any required protocol modifications.

Your IRB protocol must state that you are receiving data from the "CCTS CRDW - UIC CIRCLE" and all data elements requested should be detailed in the protocol document as well.

If this is already stated in your protocol, please ensure that the data elements requested on this form match what is approved in your protocol documents.

* must provide value

Yes - My request requires IRB approval, and I will need to submit an amendment or new application

Yes - My request requires IRB approval, but I have already stated these required items on my approved protocol

No - My request is exempt

I need assistance in determining whether my request requires IRB approval

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Summary of Required Documents and Approvals:

DRA=Data Request Authorization [Form]
IDUA=Internal Data Usage Agreement

Note: After your completed DRA form is reviewed, you will receive a personalized summary of your requirements from the CCTS BI Core Manager.

Upload IRB Protocol, if available

Note: For all requests requiring IRB approval documentation (protocol and approval letter - see table above), your research protocol must indicate that you are receiving data from "CCTS CRDW - UIC CIRCLE" and should include details on all data elements you plan to retrieve. If you do not have the IRB protocol ready at this time, please send it to the BI Core Manager via email once it is complete.

Upload file

IRB Approval(s) or Non-Human Subjects Determination

Upload file

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