Completion of this form is required for all requests for CTSI Informatics services. Upon submission, one of our service experts will correspond with you directly when your request is next in their queue.
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 needed for your research or business purposes, per the HIPAA minimum necessary standard.
Please note:
If you only partially completed any of the required fields above, we cannot process your request and it will be deleted in 7 calendar days. The form will be considered incomplete if you are making data request and don't provide initial in the PHI Agree section URMC and Affiliates 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
IT Systems & Tools for Research
Trial Feasibility (CTSI OCR Staff only)
COVID-19 Biobank sample request
Secure Environment for Research Data Analytics (SERDA)
CTSI Quality Improvement (CTSI Staff only)
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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If this data will be used for research or planned research, 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).
If this data is NOT for a research project, are you the project lead?
* must provide value
Yes
No
Please provide the name of the principal investigator, intended principal investigator if still conducting feasibility, or project lead if not research:
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Email of project lead.
* must provide value
Project title 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
Please indicate whether your project is Preparatory to Research (feasibility) or IRB approved?
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Preparatory
IRB Approved
Please note that the request of COVID-19 BioBank specimen is only available to existing IRB approved research study.
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.
* must provide value
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.
* must provide value
TriNetX query result
I already have a list of patients 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.
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
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:
* must provide value
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.
* must provide value
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.
* must provide value
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.
* must provide value
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.
* must provide value
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.)?
* must provide value
What is the sample size of your study?
* must provide value
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?
* must provide value
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 the support you need from the CTSI IT Systems and Tools specialist.
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).
Please provide details describing your quality improvement project.
* must provide value
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