Data Request Agreement
utCRIS Clinical Research Data Warehouse
Principal Investigator (P.I.) Name:
Submitter name (if other than P.I.)
Submitter phone:
Submitter email:
Request date:
Account Number to charge request to:
Project title:
IRB Number(s):
IRB Approval Date:
Will this data leave the UT Southwestern Campus?
What data are you requesting?
Date Range of Data
Provide all requested ICD9 Diagnosis Codes (Provide logic: And, Or, Not)
Provide all requested CPT Procedure Codes (Provide logic: And, Or, Not)
List any Demographic Characteristics (Age, Gender, Race, Ethnicity etc…)
Clinical Laboratory Data – Provide both Test Name and Test number of Lab Procedures as well
as any specific values that are needed.
Radiology Procedures - Provide both Test Name and Test number of Radiology Procedures
Anatomical Pathology Reports – Provide as much detail as possible
Medications (Choose either Ordered Medications or Current Medication which include selfreported medication)
For internal use only
Reviewed date:
Date Data was provided:
CRDW Staff Member providing report:
□ I am an investigator with an IRB-approved research project. I am requesting access to a
specific utCRIS Clinical Research Data Warehouse dataset in order to complete the research
project, as detailed in the attached data request form. Responsibility for the security of data will lie
with all study team members and the principal investigator.
Under HIPAA regulations, the IRB/Privacy board has deemed access to these data allowable by
(mark all that apply):
□ IRB approved request of de-identified information
□ Investigator attestation that research involves only decedent’s information
□ IRB approved HIPAA authorization
□ IRB approved Waiver of HIPAA authorization
□ De-identified Data
□ IRB approved Data Use Agreement (if limited data set is going to be shared outside UT
Southwestern for an investigator not named on the UT Southwestern HIPAA Authorization form)
For de-identified datasets, possible indirect identifiers (e.g. rare diseases, extremes of age, and
combinations of data elements) will be obfuscated as needed to ensure privacy. utCRIS staff will
review the investigator’s plans for data storage and transfer to ensure plans are consistent with
the current UT Southwestern policies for data security. Remediation will be the responsibility of
the investigator and must be completed prior to data release. The data recipient assumes all
responsibility for data security once data are released from the utCRIS.
• I acknowledge that the data I request will be in compliance with the IRB approved research
protocol and that the data I receive will be in use only for the duration of the IRB approval for my
project. Should a project’s approval lapse, utCRIS staff will cease providing access to data to the
researcher for that study until there is evidence of approval unless the IRB determines that
access is necessary to protect the health, welfare, and safety of human subjects. I also
acknowledge that I will not share any of the data I receive with any other researchers or entities
outside of the investigators or research staff listed on the protocol or as approved by the IRB, nor
will I conduct any research with the dataset that is outside the scope of the IRB approval for this
project.
• I acknowledge that the data I request may not be under the jurisdiction of the utCRIS team. In
this case, the utCRIS cannot provide the data requested, but can help direct the investigator to
the appropriate party.
• I acknowledge that utCRIS staff may verify for each subject whether that subject has refused or
consented to participate in genetic research. Data from subjects who have refused to participate
in genetic research will be excluded from the dataset for genetic studies or will be flagged for
exclusion from genetic research by the investigator. I acknowledge that I will not use data from
subjects that are flagged for exclusion for any genetic research.
• I acknowledge that in order to facilitate processing of my request, utCRIS staff will be given
access to IRB study information within the UT Southwestern IRB system. I further acknowledge
that I may be required to provide proof of continuous IRB approval if using another IRB.
• I acknowledge that utCRIS staff will report all disclosures, in cases where accounting for
disclosures has been required by the UT Southwestern Privacy Office.
By completing the required information above and signing the form where noted, the Investigator
accepts the above conditions and agrees to abide by the utCRIS rules as stated above.
Printed name of PI requesting to receive data _______________________________________
Signature of PI __________________________ Date signed __________________________