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Required format:

OBGYN STUDY INTAKE FORM

Returning?

A A A

PLEASE READ BEFORE SUBMITTING

This intake form is used to obtain departmental approval for IRB submissions and/or get assistance with study planning and grant submissions.

This form is NOT for Data Service Requests; those can be submitted at: https://is.gd/washuobgynrequest.

A few notes to guide you:

Study planning/grant planning intakes: Include a basic research plan outlining study aims, and preliminary recruitment/data collection logistics. A 'one-pager' that succinctly summarizes the plan in lay language is ideal.
IRB approval intakes
- You should already have a draft protocol created in the myIRB system, with as many details as possible filled in. DO NOT SUBMIT THIS INTAKE until you have initiated a draft.
- If you feel you need more guidance before initiating an IRB protocol, you can submit this intake under the "Other (study consult)" category.
- You should not submit an IRB intake until you have secured funding (internal or external) - or if you received a JIT request.
Important: Due to the volume of intakes we receive, we prioritize grant proposals and IRB submissions for FUNDED projects over unfunded projects. If you have a hard deadline for an unfunded project, please explain details in a the notes box.

Questions can be directed to: obgynresearch@email.wustl.edu

Name of person completing this intake form

* must provide value

Date form entered (started)

* must provide value

M-D-Y

PI Name (last, first)

* must provide value

PI Division

* must provide value

General Gynecology

Family Planning

MFM

Gyn Onc

MIGS

FPMRS

REI

PAG

DCR

CRepHS

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The Study PI listed above is: (choose one)

* must provide value

Faculty

Fellow

Resident

Post-doc

Other trainee

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Faculty mentor name (last, first)

* must provide value

Please indicate the PRIMARY purpose of this intake:

PLEASE NOTE: Grant/LAB proposals should be completed before IRB submissions. We prioritize IRB protocol submissions for FUNDED projects first. If you have a deadline for an unfunded project, please include a note with relevant details.

DATA SERVICE REQUESTS can be made at: https://is.gd/washuobgynrequest

* must provide value

LAB proposal

Other grant proposal

IRB submission/departmental approval

Other (i.e. consult, general study planning)

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When is the grant due?

M-D-Y

Do you plan to pursue this project if the LAB/grant is not funded?

* must provide value

Yes

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Please indicate how you plan to conduct the project if your proposal is not funded (including funding source if applicable).

* must provide value

Study Nickname (i.e. short title)

* must provide value

Type of study (choose the best option)

* must provide value

Chart review or analysis only (no recruitment needed)

Biobank specimen acquisition/analysis only (no recruitment needed)

Prospective data/specimen collection (requires patient recruitment)

Intervention, drug, or device trial (requires patient recruitment)

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Brief Description of Study

* must provide value

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Attach Study Information (e.g. grant proposal, protocol, one-pager, etc.)

Upload file

Do you plan to enroll pregnant patients?

* must provide value

Yes

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Where do you plan to enroll pregnant patients? (select all that apply)

NOTE: The locations listed are pre-approved research sites. Conducting research in other locations may not be permitted/feasible.

* must provide value

COH3 OB Clinic

COH7 OB Clinic

Fetal Care Center

Labor & Delivery

WAC

Antepartum

Postpartum

Other

Do you plan to enroll non-pregnant patients?

* must provide value

Yes

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Where do you plan to enroll non-pregnant patients? (select all that apply)

NOTE: The locations listed are pre-approved research sites. Conducting research in other locations may not be permitted/feasible.

* must provide value

COH3 Clinic

COH7 Clinic

REI

Barnes Jewish Hospital

Other

Do you intend to collect any data/specimens on Labor & Delivery?

* must provide value

Yes

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Please describe your plans for identifying and enrolling patients into your study (e.g. screening methods, when/where/how you will contact and enroll patients, who will perform these tasks, etc.).

* must provide value

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Please describe your study procedures including all patient activities and data collection needs.

* must provide value

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Do you have a myIRB application drafted?

NOTE: Investigators (or coordinator/designee) should create the initial protocol draft in myIRB, completing as much as possible.

* must provide value

Yes No

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REMINDER! Please be sure that Kristen Powers and Cassara Cook are listed as delegates for you in the myIRB system. They will not be able to review your protocol until they are added.

Instructions for adding delegates:

Log in to myIRB.
Click on "Personalize" at the top of the page, then click on "Update my delegates".
Enter the first three letters of the last name of the delegate, then select the appropriate delegate from the dropdown menu, then click on "Add Delegate".
The delegate will now be listed in the box titled User Delegates.

****You or your designee will need to complete the first draft of the myIRB protocol before the Regulatory Team will review it. Please alert us when you have completed your first draft (obgynresearch@email.wustl.edu).****

If you need guidance on planning your study logistics, you can contact the DCR at obgynresearch@email.wustl.edu

REMINDER; Be sure that Kristen Powers and Cassara Cook are listed as delegates for you in the myIRB system. They will not be able to review your protocol until they are added. Instructions are shown below:

Instructions for adding delegates:

Log in to myIRB.
Click on "Personalize" at the top of the page, then click on "Update my delegates".
Enter the first three letters of the last name of the delegate, then select the appropriate delegate from the dropdown menu, then click on "Add Delegate".
The delegate will now be listed in the box titled User Delegates.

Please attach the myIRB application draft (only necessary if Kristen Powers/Cassara Cook are not listed as delegates)

Upload file

How will this study be funded? (choose all that apply)

* must provide value

Grant or contract

Division/Department funds

Faculty research fund

Other

Unsure/unfunded

Which DCR supports/services do you need (check all that apply)?

* must provide value

Recruitment (screening, enrolling)
Outpatient survey/specimen collection
Inpatient survey/specimen collection
Specimen processing/storage
Chart extraction/data entry
Project management/regulatory
Data management/REDCap development
Data analysis
Other
None

DCR services are available for a fee. Your responses indicate internal or no funding.

Please describe how you plan to pay for DCR services and provide a fund # if available.

Please contact DCR Manager, Jaime Strickland, for fees and assistance with budgeting (jaime.strickland@wustl.edu)

* must provide value

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Coordinator/Contact Name (if different than PI)

Include any additional Information that is relevant to this project

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Attach any other files helpful to processing this intake form

Upload file

Attach any other files helpful to processing this intake form

Upload file

Complete initial review now?

This is to be completed by the DCR regulatory team or management ONLY.

Yes

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Reviewed by (please choose your name if/when you review)

Inquiry status (please update status after reviewing)

In progress = still gathering info/discussing

Complete = review is complete (may still be waiting for IRB approval, funding, etc.)

Review notes

- Include any relevant discussion points or status notes
- Include data Project ID, if applicable

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Is this for a LAB proposal?

* must provide value

Yes

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Project status

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.