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Completion of this form is required for all requests to the CTSI Informatics service branch. Upon submission, one of our service experts will correspond with you directly, when your request is next in their queue.
Partially completed forms cannot be processed and will be deleted in 7 calendar days. This form will be considered incomplete if you are making a data request and don't provide initials in the PHI Agreement section. If you are requesting a clinical data set, you are required to comply with HIPAA privacy regulations for appropriate uses and disclosures of PHI (Protected Health Information). You must limit your request of PHI to only the information required to conduct your research, per the HIPAA minimum necessary standard.
Additional information on HIPAA requirements can be found on the URMC and Affiliates intranet site. .
PLEASE NOTE: The CTSI Informatics service does not provide eRecord data for non-research projects. Please contact the UR Medicine Quality Institute for non-research initiatives such as QI/QA, hospital operations, etc. Data and service requests for such projects can be submitted at the Quality Institute intranet site .
What Informatics service are you interested in?
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Clinical Data Request - Use this service line for:
Study Design and Planning
Data Analysis
Population Health
Informatics Consultation - Data and Tools
Trial Feasibility (CTSI OCR Staff only)
COVID-19 Biobank sample request
Secure Environment for Research Data Analytics (SERDA)
CTSI Quality Improvement (CTSI Staff only)
TriNetX Research Dataset Request
BLIS or Biobanking
If you need more than one service area, select your primary need. We will triage your request within the informatics team.
Request Date
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Today M-D-Y
First Name
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Last Name
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Department
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Email
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Phone
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Are you the principal investigator?
NOTE: If you are the project lead, study coordinator, health project coordinator, sub-PI, or other project team member, you are NOT the principal investigator.
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Yes
No
Please provide the name of the principal investigator, intended principal investigator if still conducting feasibility:
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Email of principal investigator:
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Study name for future correspondence
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Due Date
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Today M-D-Y
Is this request for research?
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Yes
No
Based on your response, the project for which you are requesting data is not a research project. The CTSI Informatics service does not provide eRecord data for non-research projects. Please contact the UR Medicine Quality Institute for non-research initiatives such as QI/QA, hospital operations, etc. Data and service requests for such projects can be submitted on the Quality Institute's intranet site .
Covid Samples are for IRB Approved Research Studies only. Please indicate whether your project is Preparatory to Research (feasibility) or IRB approved?
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Preparatory
IRB Approved
Please note that only aggregated counts (no row level data) can be returned for the preparatory to research request of COVID-19 BioBank specimen. Has the IRB determined that your study is "exempt" from further review?
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Yes
No
Approval end date:
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Today M-D-Y
True
False
Please upload the HIPAA Preparatory to Research form, 25.3; it is accessible
here .
After completing the HIPAA 25.3 form, you will receive an email with your form attached as a PDF file. Please upload the file here.
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Please identify the IRB that reviewed and approved the study protocol.
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IRB Study ID#
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Please provide a copy of the most current IRB review letter.
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Please upload your protocol/plan.
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What is the funding source for your study?
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NIH Industry URMC Other Not Funded
You indicate that this data is not needed for a research project (i.e. your project is NOT either preparatory to research or IRB approved research). Please provide a detailed description of your non-research project.
The patients who will populate your data set will come from what source?NOTE : We strongly recommend that investigator provided patient lists include eMRN (ie NOT SMH MRN, HH MRN) to avoid a delay in production time.
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TriNetX query result
I already have a list of patients representing the study population and will upload a spreadsheet to this form.
I will provide selection criteria for the CTSI to find the patients.
You indicated above that the source for your population will be a TriNetX query. TriNetX is a cohort discovery tool that is available through the CTSI website here: https://www.urmc.rochester.edu/clinical-translational-science-institute/informatics/trinetx.aspx
Using TriNetX you can build a query and identify (count) populations that meet specific criteria. This section of the request form is specifically for those who have used TriNetX and want us to reidentify the population of a query result. Additionally, we can use a TriNetX population as the basis for extracting a data set/list of variables. If either of these options is not what you intended, you either:
(1) already have a known set of patients that you will upload to this request
OR
(2) want us to find the population.
If either (1) or (2) apply to you, please go back to the previous section of this form and make another selection.
The next few questions are for TriNetX users ONLY . They will help us identify your specific TriNetX query .
IMPORTANT: AFTER COMPLETING THIS FORM, YOU MUST GO TO THE TRINETX STUDY (IN THE TRINETX TOOL) THAT CONTAINS THE QUERY FROM WHICH WE WILL EXTRACT THE POPULATION, AND "SHARE" THE STUDY WITH USER: "DAVID J. PINTO". IN TRINETX GO TO: STUDY MANAGEMENT--> TEAM--> SHARE STUDY.
This data represents aggregated results from the TrinetX research network, representing over 100 different healthcare organizations (HCO) and over 110 million patients. TriNetX harmonizes electronic medical record (EMR) and other real-world data (RWD) sources from these healthcare organizations, allowing researchers to explore structured, deidentified patient facts within populations matching custom criteria on a user-friendly analytics platform. The deidentified results will not reveal from which HCOs the data is derived, including URMC .
To proceed with this request:
A dataset request must be submitted on TriNetX for a query built on the TriNetX Research network. TriNetX works with PI to create Data Set Order form The licensing terms, including pricing for the TriNetX data set, are subject to negotiation between you and TriNetX. If you are not the principal investigator, the PI details must be provided in the appropriate fields in this form. The PI will be notified of this request and must be included on all communications between yourself, CTSI, TriNetX and ORPA. PI create a new DUA in IORA and attach the Data Set Order form TriNetX will email PI the link to the dataset after the Data Set Order form is fully executed. CTSI must be included on all communications related to this request at: CTSI_Informatics@URMC.Rochester.edu If you want to request a TriNetX research network dataset and have submitted a request for a research network dataset within TriNetX, please complete this form.
If you are looking for a URMC data set, identifiable data, or something else, please go back to the previous section of this form and select Clinical Data Request.
If the TriNetX query was developed by someone other than yourself, please provide their username (URMC email).
TriNetX Study Name:
** DONT FORGET TO "SHARE" THE STUDY IN TRINETX, PER THE PREVIOUS INSTRUCTIONS!
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Name of TriNetX query that you want to pull data from:
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TriNetX query date and exact time:
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M-D-Y H:M
What is the funding source for your study?
* must provide value
NIH Industry URMC Other Not Funded
If other, please specify:
What is the purpose of the data request:
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How is the study cohort (inclusion/exclusion) defined?
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Is it limited to UR patients?
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Yes
No
How does the study team plan to use/analyze the dataset downloaded from the TriNetX Research network?
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Does the team have the capacity to handle a large volume of data?
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Yes
No
How long does the study team need to license the dataset from TriNetX?
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Please upload the data set order form you received from TriNetX. If you do not have an order form yet, please provide it to the CTSI upon receipt.
Yes
No
Please upload your complete Sample Request Application. The COVID-19 Biobank Governance Committee will review your application request and inform you of their decision.here .
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What type of sample do you need?
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What is the number of unique COVID-19 subjects (i.e. subjects that have had at least 1 positive COVID-19 PCR test) you need?
What is the number of unique control subjects (i.e. subjects that never have had a positive COVID-19 PCR test) you need?
What is the minimum serum volume needed per subject?
Do you want longitudinal inpatient serum samples from the same subject?
Yes
No
If yes, please describe your ideal time period between draws?
What is the number of unique COVID-19 subjects (i.e. subjects that have had at least 1 positive COVID-19 PCR test) you need?
What is the number of unique control subjects (i.e. subjects that never have had a positive COVID-19 PCR test) you need?
What is the minimum cell count needed per subject?
Do you want longitudinal inpatient serum samples from the same subject?
Yes
No
If yes, please select request inpatient time points (close to admission, ~3-5 days, ~8-10 or discharge)
What is the number of unique COVID-19 subjects (i.e. subjects that have had at least 1 positive COVID-19 PCR test) you need?
What is the number of unique control subjects (i.e. subjects that never have had a positive COVID-19 PCR test) you need?
What is the minimum plasma volume needed per subject?
Do you want longitudinal inpatient serum samples from the same subject?
Yes
No
If yes, please select request inpatient time points (close to admission, ~3-5 days, ~8-10 or discharge)
Do you want plasma subjects and timepoints paired with PBMC subjects and timepoints?
Yes
No
Patient Selection Criteria:
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What data are you looking for?
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What tool are you planning to use to work with your data? (please select all that apply)NOTE - DATA DELIVERY PROCEDURES :
When the data volume of an individual data set is small (< 1 million rows), data will be delivered on spreadsheets (Excel). This applies to most reports.
When the data volume is large, data will be delivered in tab-delimited plain text format (.txt file extension).
When the data volume is over 500MB, the preferred delivery mechanism is direct deployment to the requester’s SMDNAS folder. Alternative solutions will be considered, contingent on HIPAA and regulatory compliance. This is handled in a case-by-case basis because requesters may not have suitable network resources to receive data.
A data report may be delivered using more than one solution.
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What HIPAA dataset do you have IRB approval for?NOTE: This applies to the data that you receive from us, not how your study team will treat the data during or after analysis.
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Identifiable data
Limited Data Set (no PHI except ALL dates and Zip codes)
De-identified data
How will this data be used?
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Will this data be disclosed to anyone else (within URMC) besides the requestor? If "yes" document who in the "Comments" section.
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Yes
No
Will this data be disclosed to a third party outside URMC and Affiliates? If so document who in the "Comments" section.
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Yes
No
Will the population be activated for the "MyChart For Recruitment" utility, as per the CTSI Research Services branch?
NOTE: The "MyChart For Recruitment" tool requires a preliminary consultation with the Research Services staff at the CTSI. Select "Yes" here ONLY if you have had, or plan to have such a consultation.
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Yes
No
Please upload any data sets or other information that might assist us in understanding and processing your data request.
PHI Agreement (initials)
I understand and agree to comply with all URMC and Affiliates HIPAA policies regarding the use and disclosure of PHI.
Additional information on HIPAA requirements can be found on the URMC and Affiliates intranet site
here. * must provide value
This service includes determining the best methodologies (mixed methods, quantitative, qualitative), study design, study implementation strategies, and analytical plans to answer your research questions.
Which aspects of study design are related to your request?
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Please briefly describe your request.
Please upload any relevant files to assist with our first meeting that have not already been uploaded to the Research Request Dashboard.
The data analysis service help you make plans to develop or apply analytic and statistical methods to biomedical data.
Please provide a brief description for your research question/project.
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Please provide a detailed description of your study design.
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How will this data analysis be applied?
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Please list:
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How is your data formatted (statistical software, CSV, Excel, txt, etc.)?
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What is the sample size of your study?
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Please provide additional supporting/clarifying information for the sample size question, if necessary.
Please provide any other supporting information for your data analysis question(s).
Please provide a deadline for your data analysis.
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Today M-D-Y
Please upload any files with additional information that supports your data analysis request.
This type of request is for information relevant to the review, description, accessibility, or collection of health data for a general or specific population.
Please briefly describe your population health request.
What type of population health support do you need?
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What geographic level of data are you interested in?
* must provide value
For what unit-of-analysis are you planning?
* must provide value
Please upload any files with additional information that supports your population health request.
This service provides advice regarding innovative information technology, systems and tools, databases, or related methods, to support your research projects
Please provide details describing your project and what you want to get from consultation.
* must provide value
Please upload any information to support your request.
The Secure Environment for Research Data Analytics (SERDA) is a secure environment for researchers to access and analyze clinical data containing protected health information (PHI). It offers analytical tools, secure data storage and data backup - all accessible from your desktop.
Please provide details describing your project and why you are interested in joining Secure Environment for Research Data Analytics (SERDA).
* must provide value
Please provide details describing your quality improvement project.
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This service provides advice regarding study data pipeline, integration and management using CTSI's Biolab Informatics Server (BLIS) system, or biobanking need for your research projects.
Please provide details describing your project and what you want to get from consultation.
* must provide value
Please upload any information to support your request.
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