READi Project Intake Form

READi Project Intake Form

Questions? E-mail us at readinavigators@unmc.edu.

DO NOT ENTER ANY PHI INTO THIS FORM - INCLUDING MRN's

Qualified Investigator First Name*

*A Qualified investigator is a UNMC Faculty Member or a staff member of the Health System from which data is being requested.

Qualified Investigator Last Name*

*A Qualified investigator is a UNMC Faculty Member or a staff member of the Health System from which data is being requested.

Is the Qualified Investigator the PI of the Project?*

Yes

Qualified Investigator Email Address*

This email address will be the designated contact for our team, expect future correspondence to be exchanged with this address.

Select or enter value

Qualified Investigator College*

Select

Should someone else be included in communications regarding this request?*

e.g. A Project Coordinator, student/fellow on project, etc.

Please note that automated status update emails will be sent to the contacts listed below as well as the Qualified Investigator's email address.

Yes

Additional Contact's Name

Additional Contact's Email Address

Additional Contact 2 Name

Additional Contact 2 Email Address

Is there a statistician associated with this project that will need data shared with them?*

Yes

Would you like us to connect you with a statistician to help with analyzing data for your project?*

Yes

Statistician Email Address:*

Preferred Project Name*

Is this project a feasibility ONLY request at this time?

Yes

Is this a follow-up submission to a prior feasibility request?

Yes

What was the prior request number or name?

Is this request for a student project?*

Yes

Student Project Statement

If EHR is to be used for a student project, the supervision of a faculty member with EHR data expertise is required.

What is your primary research question?*

My project is currently...

Very Early: I am looking for collaboration to fully form it AND/OR numbers to determine if it's feasible.

Beyond ideation, but not full formalized: My project has a well-developed research question but does NOT have actionable inclusion/exclusion criteria AND/OR a complete data collection plan AND/OR a complete data analysis plan.

Formalized and complete: My project has a well-developed research question AND actionable inclusion/exclusion criteria AND a complete data collection plan AND a complete data analysis plan.

My project involves multiple sites/institutions.*

No, it is only at UNMC (Nebraska Med and/or Children's)

Yes

UNMC is the central IRB?

Yes

Unsure

My project involves only historical data.*

My project involves historical data only

My project involves prospective data only

My project involves both historical and prospective data

My project is best described as...*

Research

Registry Build [i.e Creation of a data registry for the purpose of banking data (including PHI) for future, unspecified research]

QI/Program Evaluation

Data Source List*

Select all that apply.

Electronic Health Record

Nebraska Biobank (Only limited non-PHI data available in biobank database)

Nebraska Hospital Association

Other administrative data (e.g. Medicaid/Medicare claims, national survey data, etc.)

Registry that Nebraska Medicine participates in

Registry that Children's Nebraska participates in (e.g. PHIS, STS, etc.)

Data Collection Form Built by READi

Other

I don't know yet

Which Health System?

Select all that apply

Nebraska Medicine

Community Connect Site (Requires direct permission from the site)

Children's Nebraska

Which Community Connect Site?*

What other administrative data sources would you like to use?

Which Nebraska Medicine registry:

Which Children's Nebraska associated registry:

Please specify any other data sources you would like to use:

IRB Status*

HIPAA Identifier Definitions

Get IRB Determination Here

Completed

No, This project is still in the design phase and the IRB is still in process

No, this project will use only de-identified data (please check to make sure you need none of the 18 identifiers per HIPAA before selecting this option)

No, this project is not human subjects research (e.g. QI, operations, etc.)

No, this is a biobank only request and thus doesn't require an IRB

Please provide justification of ethical access to this patient database:*

What are your inclusion criteria?*

Please use standardized codes when possible (e.g. ICD for diagnoses, CPT for procedures, etc.)

What are your exclusion criteria?*

Please use standardized codes when possible (e.g. ICD for diagnoses, CPT for procedures, etc.)

What is the time-frame these criteria should be run for?*

e.g. admitted within the last 5 years, visits occurring between 1/1/20 and 12/31/22, etc.

What additional counts besides total # of patients meeting inclusion/exclusion criteria are needed?

e.g. basic demographics, proportion admitted, etc.

What is the unit of analysis (i.e. the row) of the problem you are looking at with these data (e.g. patients, encounters, etc.)?

Which variables would you like reported about the patients/encounters/etc. that meet inclusion/exclusion criteria?

Specimen Type/Volume Requested:

Select all that apply.

Serum (500 μL / sample)

Plasma (500 μL / sample)

DNA (2 μg / sample)

Number of patient samples needed:

Enter '0' if only control samples are needed

Please specify Tissue type:

Please specify specimen type:

Number of control samples needed:

Enter '0' if no control sample needed

Please specify what assay(s) will be performed:

Who will perform these assays?

Specimen will be transferred outside of one of the NU campuses.

Where will the requested specimens be stored and evaluated?

Do you need our assistance identifying subjects for recruitment?*

Yes

Will you be using Opt-In?

Yes

Will you need data imported into REDCap so additional data can be collected manually or directly from patients?

Yes

Will you need our assistance to build the REDCap?*

Yes

Please provide a link to the REDCap:

Will these data be needed just once, or will you need it to be refreshed on a regular basis?

Just Once

Refreshed Regularly

The funding* status of my project is:*

*Funding of any type including departmental funding.

Not funded with no plans for funding

Not funded, but applying for funding

Funded and in pre-award planning

Funded and on the clock

Please provide any additional details that you believe would be helpful (e.g., project objectives)

UPLOAD FILE(S) HERE:

Please upload the following as applicable:

DO NOT UPLOAD ANY PHI - INCLUDING MRN's

1) The central site IRB protocol (if using a central IRB other than UNMC).

2) If this project is a QI Project and/or not human subjects research, the letter from the IRB must be uploaded below.

Get IRB Letter Here

3) If requesting Community Connect data, upload proof of permission from the Community Connect Site.

4) An excel spreadsheet with columns labeled with the variable names you would like in your report. (This is optional but helps us make sure what we build matches what you expect to receive).

Drag and drop files here or

Send me a copy of my responses

Project Information

Student Project Statement

Data Sources

IRB Information

UPLOAD FILE(S) HERE: