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WUSTL COVID-19 Research Request Form

In this time of unprecedented research need, the Washington University Institute of Clinical and Translational Sciences is coordinating Washington University COVID-19 research activities to prioritize, promote, and actively support the most promising studies, and enhance patient safety.

The COVID-19 pandemic has caused major changes to the conduct of patient care and research at Washington University (WU) and BJC hospitals. For basic and clinical/translational research alike, study design and conduct must comply with WU/BJC policies on COVID-19 infection prevention, and should reflect federal, state, local, and University recommendations. Institutional leadership has invested the ICTS with the additional responsibility and authority to determine which COVID-19 studies may go forward, and which merit prioritized support.

All prospective interventional studies that plan to enroll inpatients at BJH or SLCH must submit a description of their work below and will be reviewed by the COVID Clinical Studies Committee (CSC) and other applicable committees within the ICTS research governance structure. The CSC will review clinical studies with a particular focus on the burden they pose to patients, front-line providers, and resources.

We expect investigators to receive feedback within approximately 2-4 weeks of ICTS survey completion, PROVIDED sufficient information is submitted to enable a quality review. Review times will be highly dependent on the level of detail provided.

At a minimum, the following study details will be required before a review will be initiated:

1) An updated study protocol, or if not available, details on the following:

The study hypothesis and objectives, participant eligibility criteria (including whether they are COVID positive, under evaluation for COVID, in convalescent phase, or other status).
The locations and means by which participants will be recruited. The nature (drug, device, biologic, other) and regulatory status (approved indication, off-label use, investigational) of the intervention.
Targeted recruitment goal (at WU site specifically) with brief statistical justification.
Nature (in-person visits, remote visits, blood/imaging/other testing methods) and duration of follow-up assessments.
Safety precautions and monitoring.
Ways in which COVID-19 infection of the participants, research workers, and others will be avoided.

2) Informed consent document, if available

3) Any other relevant study documentation as available

Please complete this form for your planned COVID-19 research projects at Washington University in St. Louis. Complete a form for each individual research project involving an intervention.

Please view the COVID-19 Clinical Research page for more information about the submission of interventional clinical studies.

If there are questions about the review process or required study documents, please contact Tera Jarvis at tjarvis@wustl.edu

Please note, as of March 2022, researchers are only required to submit details for prospective interventional clinical studies that enroll inpatients at BJH or SLCH. If this study does not contain an interventional component, you may discontinue the survey. If there are any questions, please contact Tera Jarvis at tjarvis@wustl.edu.

Research Team Information

Please enter the following details about the Principal Investigator (PI)

PI Name:

* must provide value

PI email address:

* must provide value

PI phone number:

* must provide value

PI Department:

* must provide value

Please enter details about the Secondary Contact

Contact Name:

Contact email:

Contact phone number:

Funding

Please identify Funding Sources being sought or secured

* must provide value

Departmental/Internal

NIH

Industry Partner (specify)

Foundation (specify)

Other (specify)

None

Specify Industry Partner

* must provide value

Specify Foundation

* must provide value

Specify Other

* must provide value

Secured

Being Sought

Departmental/Internal

NIH

Industry Partner

Foundation

Other

Please provide a 1-paragraph summary of resources (funding, study drug, staffing, etc.) required to conduct the study, including what has been procured by what mechanisms (NIH, industry, other). If there are additional gaps in resources, please identify.

* must provide value

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Research Details

Study Title

* must provide value

Expand

Brief description of the proposed work:

* must provide value

Expand

Please Indicate the Type of Research (check all that apply)

Prospective interventional clinical trials

Other interventional clinical study

Observational study

Other non-interventional clinical study

Biosampling and phenotyping

Retrospective electronic health record data analysis

Other (specify)

Specify Other

Is this a multi-site trial?

* must provide value

Yes

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Please indicate WUSTL's role in the multi-site trial:

* must provide value

Lead site

Participating site

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What type of IRB is being used

* must provide value

WUSTL IRB as central IRB

External IRB as central IRB

No central IRB is being used

Uknown

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IRB Status

* must provide value

Not yet submitted

Submitted and under review

Approved

Other (specify)

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Please enter details about the patient population and enrollment

What is the enrollment target? If this is a multisite study, please specify WU-specific target.

* must provide value

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Research location (check all that apply)

* must provide value

Outpatient

Inpatient: Non-ICU

Inpatient: ICU

Emergency Department

Other (specify)

Does this study plan to enroll health care workers as study participants?

* must provide value

Yes

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Please specify the type of health care workers

* must provide value

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Resources

Please select any resources needed to facilitate the study (check all that apply).

Please note, this list does not guarantee the below services are immediately available, but simply assesses general resources required for study conduct.

Additional clinical coordinator staff

Case report form development

Collaborators

Consent form preparation

Data management

Data and Safety Monitoring

EHR access

Electronic consent form preparation

IRB protocol preparation and submission

Multicenter study coordination or guidance

Recruitment support

Statistical assistance

Study design

Other (specify)

None

Specify Other

Study Documents

Is there a protocol?

* must provide value

Yes

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Please upload the protocol or other detailed study synopsis

Upload file

At a minimum, the CSC will need to understand some key aspects of the proposal. Please upload a text document including the following information:

The study hypothesis and objective
Participant eligibility criteria (including whether they are COVID positive, under evaluation for COVID, in convalescent phase, or other status)
The locations and means by which participants will be recruited
The nature (drug, device, biologic, other) and regulatory status (approved indication, off-label use, investigational) of the intervention
Targeted recruitment goal (at WU site, specifically) with brief statistical justification
Nature (in-person visits, remote visits, blood/imaging/other testing methods) and duration of follow-up assessments
Safety precautions and monitoring
Ways in which COVID-19 infection of the participants, research workers, and others will be avoided.

Upload file

If there is an approved or draft version of the Informed Consent, please attach:

Upload file

Please attach any Pharmacy Manual(s), if available:

Upload file

If there is other relevant study information (e.g., Investigator Brochure), that might assist the CSC in their review, please attach:

Upload file

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