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Required format:

/^((0?[1-9])|([1-8][0-9])|(9[0-8]))[0-9]{3}$/

/^((29([-\/])02\3(\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00)))|((((0[1-9]|1\d|2[0-8])([-\/])(0[1-9]|1[012]))|((29|30)([-\/])(0[13-9]|1[012]))|(31([-\/])(0[13578]|1[02])))(\11|\15|\18)\d{4}))$/

/^((02([-\/])29\3(\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00)))|((((0[1-9]|1[012])([-\/])(0[1-9]|1\d|2[0-8]))|((0[13-9]|1[012])([-\/])(29|30))|((0[13578]|1[02])([-\/])31))(\11|\15|\19)\d{4}))$/

/^(((\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00))([-\/])02(\6)29)|(\d{4}([-\/])((0[1-9]|1[012])(\9)(0[1-9]|1\d|2[0-8])|((0[13-9]|1[012])(\9)(29|30))|((0[13578]|1[02])(\9)31))))$/

/^(((\d{2}([13579][26]|[2468][048]|04|08)|(1600|2[048]00))([-\/])02(\6)29)|(\d{4}([-\/])((0[1-9]|1[012])(\9)(0[1-9]|1\d|2[0-8])|((0[13-9]|1[012])(\9)(29|30))|((0[13578]|1[02])(\9)31)))) (\d|[0-1]\d|[2][0-3]):[0-5]\d$/

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Protocol Feasibility: Part 1

Please complete the following UHCRC Project Feasibility questionnaire.

The focus of the UHCRC Feasibility Assessment is to access the number of eligible participants available for recruitment in the research project within UHHS. Research projects including sponsored research, clinical trials, and FDA regulated studies (including investigator initiated) are subject to this policy. Retrospective chart reviews, biorepositories, tissue and blood sample banking, exempt research, questionnaire studies, and behavioral research are ALL exempt from this requirement. IF research design includes elements that span both exempt (chart review) and non-exempt (FDA regulated), then this SOP would apply to that research protocol.

To obtain the number of eligible participants for the study, a query of the electronic medical record (EMR) will be conducted through TriNetX Software based on the information provided below.

Date of Submission

M-D-Y

Requestor First Name

* must provide value

Requestor Last Name

* must provide value

Requestor Email

* must provide value

PI First Name

* must provide value

PI Last Name

* must provide value

PI Email Address

* must provide value

Study Department

* must provide value

Other Department

Study Coordinator's Email

* must provide value

Regulatory Coordinator's Email

* must provide value

Velos Study Number:

Study/Protocol Title

* must provide value

Expand

Short Study Title

* must provide value

Protocol Origin

* must provide value

Study Phase

* must provide value

N/A

Phase 1

Phase 2

Phase 3

Phase 4

Post-Approval

reset

Type of Study (select all that apply)

* must provide value

Drug / Product / Supplement

Device

Surgical Procedure

Software

Biologic

Rollover/Long-Term Follow-Up (study extension)

Other (describe below)

Other

IND/IDE Holder

* must provide value

Investigator (single site)

Investigator (multi-site)

Sponsor

reset

Funding Source

Other Funding Source

* must provide value

If NIH, provide award type and PI name

* must provide value

Foundation Name/Sponsor Name

* must provide value

Study Institution

* must provide value

CWRU

reset

Is this an oncology study being conducted through Seidman CTU?

* must provide value

No Yes

reset

Study Classification- Please identify if your protocol is recruiting any of the following:

* must provide value

Rare Disease

Specific Genotype

Acute Illness

Recruiting Healthy Volunteers ONLY

Recruitment from Community Sites or Non-UH Sites

Eligibility criteria that is not available in the UH EMR systems and/or unable to be queried through TriNetX

N/A- None of the above apply to this protocol

Please explain:

* must provide value

Expand

Anticipated Accrual Across ALL Study Sites

* must provide value

Anticipated Accrual at Local Site

* must provide value

Proposed UH Recruitment/Accrual START DATE:

* must provide value

M-D-Y

Estimated UH Recruitment/Accrual STOP DATE:

* must provide value

M-D-Y

ENROLLMENT:

To obtain the number of eligible subjects for study participation, a query of the electronic medical record (EMR) BY THE CRC will be conducted through TriNetX Software based on the information provided below.

For best results, please:

1) Complete Primary Diagnosis and Age fields, as these are MANDATORY for entry into TriNetX. ICD-10 codes are preferred if available.

2) Copy and paste the inclusion and exclusion criteria directly from the most recent protocol to help narrow the focus and range of the query through TriNetX. Please be sure characters or symbols are entered correctly.

3) Please avoid using Inclusion Criteria of "must sign informed consent".

Start Date for Query

* must provide value

M-D-Y

Stop Date for Query

* must provide value

M-D-Y

Age Minimum

* must provide value

Age Maximum

* must provide value

Primary Diagnosis (ICD10)

For COVID-19 please select: "U07.1"
You can list all other codes in the inclusion free text boxes if you cannot find the exact code you need.
This field is pulled from an ICD dictionary and may be missing some newer or very specific codes.

* must provide value