Institutional Review BoardApplication Process

THCIC Program• Hospital Discharge Data• Outpatient Surgical / Radiological Procedures• Emergency Department Events

November 28, 2017

Research DataData Available for Research

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Two type of data files are available for health related research:

1. Research Data File (RDF)

2. Public Use Data File (PUDF)

Select the data file that best benefits your research needs.

Public Use Data FilePUDF

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• No DSHS IRB approval required

• PUDF released within days of payment

• Inpatient PUDF has about 290 variables

• Outpatient PUDF has about 260 variables

• Some variable masking or suppression (partial or complete ZIP

codes, patient race and ethnicity)

Order the PUDF at:http://www.dshs.state.tx.us/thcic/hospitals/Inpatientpudf.shtm

http://www.dshs.state.tx.us/thcic/OutpatientFacilities/OutpatientPUDF.shtm

Research Data FileRDF

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• RDF requires DSHS IRB approval.

• The approval process and data release can take several months.

• RDF has over 300 variables available.

• Cost is based on the number of variables and data years

selected.

• Justification for each selected variable must be provided.

• IRB application must be detailed and clear.

• Dates, data years, and data variables must match throughout all

forms.

• RDF Data must be destroyed by the project end date or must be

renewed through the DSHS program and DSHS IRB by the

project end date.

Research DataRDF or PUDF Datasets

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The following datasets are available through the THCIC program for both RDF and PUDF include:

Inpatient Data - Administrative Hospital Inpatient Discharge Claims Data

Outpatient Data - Administrative Hospital and Ambulatory Surgery Center Outpatient Claims Data. includes only those patients which received and one or more invasive surgical or radiological/imaging procedures.

ED Data - Administrative hospital based Emergency Department visit data.

Research DataRDF vs PUDF

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“What is the difference between the RDF and PUDF?”

• The RDF requires DSHS IRB approval; the PUDF does not.

• The RDF may take months to release the data; the PUDF data files

are released within days of receipt of payment.

• The RDF variables are selected individually for what is needed for

your specific IRB approved research project; the PUDF variables are

all included.

• There are more RDF variables available than what is available in the

PUDF. For example: The DSHS IRB approved RDF can have date of

birth, service dates, unsuppressed ZIP codes or patient race and

ethnicity codes. The RDF may contain Census Block or Census Block

Groups.

Getting Started

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Before contacting the THCIC program regarding your

research data request. The applicants should review and be

familiar with the following documents:

• THCIC (Inpatient, Outpatient or ED) Data Order Form(s)

• THCIC Inpatient User Manual or Outpatient Data

Dictionary or ED Manual (when available)

• DSHS IRB Forms

This will make the communications much more effective

and efficient.

RDF Program Inpatient Order Formsand User Manuals

Inpatient Order Form and User Manual are posted at:http://www.dshs.texas.gov/thcic/hospitals/RDF_IP_OrderForm.pdf• User Manual 1999-2003http://www.dshs.texas.gov/thcic/publications/hospitals/IP_RDF_DataDictionary1999_2003.pdf• User Manual 2004-3 Qtr 2015http://www.dshs.texas.gov/thcic/publications/hospitals/IP_RDF_DataDictionary2004_Present.pdf• User Manual 4 Qtr 2015-Presenthttp://www.dshs.texas.gov/thcic/publications/hospitals/IP_RDF_DataDictionaryQ42015.pdf

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Download the ProgramOrder Form(s) and review the User Manual/Data Dictionary

RDF Program Order FormsOutpatient Data Dictionaries

Outpatient / ED Order Form and Data Dictionary are posted at:http://www.dshs.texas.gov/thcic/hospitals/RDF_OP_OrderForm.pdf

• Data Dictionary 2010- 3 Qtr 2015

http://www.dshs.texas.gov/thcic/publications/hospitals/OP_RDF_Dictionary.pdf

• Data Dictionary 4 Qtr 2015-Present

http://www.dshs.texas.gov/thcic/publications/hospitals/OP_RDF_DictionaryQ42015.pdf

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Download the ProgramOrder Form(s) and review the User Manual/Data Dictionary

DSHS IRB Checklist and Forms

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DSHS IRB Application forms are located at: http://www.dshs.texas.gov/irb/applirb.shtm

Review the “Checklist” section for the type of application forms and select the most appropriate form for your situation. All new request will use the “Initial Submission Form”

DSHS IRB Required Training

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AllPersonsaccessing the data must take the required course: Human Participant Protection Education and submit their certificate with the application.

Contact the THCIC program to discuss your research study

Draft Application

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Application packet includes:

• Completed IRB forms.

• Human Participant Protection Education Certificate(s).

• Completed THCIC Order Form(s).

• Initial and sign all forms.

• Scan all forms into one PDF file.

• Email PDF file to the THCIC program at:

thcichelp@dshs.texas.gov

• Include the in Email Subject line the following:

“Draft IRB – (Name of Principal Investigator)”.

Email DRAFT application packet to the THCIC Program

Program Responseon Draft Application

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THCIC staff will review the draft application and respond to the Principal Investigator listed on the IRB application by email within 5 to 10 business days.

The THCIC staff responses are to provide feedback to the Principal Investigator on areas where the application needs more information or clarity, if needed.

Submit Finalized Application Packet

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• Principal Investigator finalizes their DSHS IRB application packet and returns to THCIC staff.

• Print out one original packet (single-sided) and one copy (single-sided) of the application packet.

• Mail both packets (one original packet and one (1) copy) to:

Regular mail:Texas Department of State Health ServicesCenter for Health Statistics, THCIC ProgramP.O. Box 149347, MC 1898Austin, Texas 78714-9347

Overnight mail:Texas Department of State Health ServicesCenter for Health Statistics, THCIC Program1100 W. 49th Street, MC 1898Austin, Texas 78756-3199

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The following DSHS programs must review and pre-approve the finalized IRB application packet prior to its delivery to the IRB Committee for placement on the meeting calendar. This pre-approval process take about two (2) weeks.

• DSHS THCIC program

• DSHS Office of General Counsel (OGC)

• DSHS Assistant Deputy Commissioner

THCIC IRB Application Process

THCIC IRB Application Process

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If any of the programs disapprove the application, the THCIC staff will notify the Principal Investigator of the contributing issues.

The Principal Investigator may submit another updated finalized application packet with the modifications.

It must include one original and one copy of the complete application packet.

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Once the application packet is pre-approved by the three review areas, the packet is delivered by THCIC staff to the DSHS IRB Administrator for placement on DSHS IRB Committee’s meeting calendar.

A pre-approved application packet must be delivered by the THCIC staff to the IRB Committee approximately three (3) weeks prior to a scheduled IRB Committee meeting. This requires submission by the Principal Investigator to THCIC staff five (5) weeks prior to the meeting

The IRB Committee meets the third Thursday of each month. (There are generally no DSHS IRB meetings scheduled for the month of August)

http://www.dshs.texas.gov/irb/applirb.shtm

THCIC IRB Application Process

THCIC IRB Application Process

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If your application is approved by the DSHS IRB Committee, it is forwarded to the DSHS Executive Steering Committee (ESC) for final approval. Note: This is Applicable for “first-time new submissions”.

Upon final decision by the IRB Committee or ESC, the DSHS IRB Administrator will email the Principal Investigator, as well as the THCIC program, whether the application is approved/disapproved. This may take about two or three weeks after the IRB Committee meeting before the Principal Investigator receives the email determination notice.

Receiving the Data

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Once THCIC staff receives the approval notice from the DSHS IRB Administrator, THCIC staff will email the Principal Investigator a billing invoice.

When the payment is received by the DSHS Accounting Office and THCIC are notified of the deposit, THCIC staff will begin building the DSHS IRB approved research dataset for your project.

The research dataset will be mailed to the Principal Investigator approximately 5 to 7 business days after the payment is received. This time may be longer for datasets that are multiple years, or for additional processes to provide the approved dataset.

Questions?

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• Contact the THCIC Program at 512-776-7261 or thcichelp@dshs.texas.gov

Data questions

• IRB FAQs at http://www.dshs.texas.gov/thcic/IRBFAQs.aspx

• Contact the IRB Administrator at 512-776-2202IRB form or required training questions