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Required format:

Core Resource Request

Returning?

A A A

Please complete the survey below so that we can best determine which Core services may best benefit your project.

Thank you!

Name of person submitting the form:

Email address for the person submitting this form:

Which Cores will your project benefit from support from?

Core A: Neuroimaging

Core B: Computational Neuroscience

Core C: Assessment, Implementation and Regulatory Support

What Core A services are you requesting? (Select all that apply)

MRI study start-up assistance and/or planning

MRI study design development

MRI staff training

MRI processing

MRI analysis

Behavioral task development

Database construction

Programming

What Core B services are you requesting? (Select all that apply)

study start-up assistance and/or planning

study design development

EEG study design consultation

EEG staff training

EEG technician

Equipment request

EEG processing

EEG analysis

General computational questions

Brown CCV Utilization

What Core C services are you requesting? (Select all that apply)

If you are unsure of which category your needs fit under, please select other.

Regulatory assistance - need help preparing initial submission to IRB, R&D, and/or Safety Committees

Regulatory assistance- need help with submission of amendment or other packages

Regulatory assistance - need help with continuing/annual status reports

General regulatory assistance - need review of prepped submissions by study team/general questions

Study start-up assistance and/or planning (SOP development, logistics, space/equipment needs, etc)

Assistance with study procedures, including Core C RA services

Statistical analysis

Data entry

Staff training

External audit preparation and/or attendance

Internal study audit/quality control

DTUA or Tech Transfer requests

FDA/IND submission

Protocol methodology/feasibility review

Grant submission

Space and/or Equipment needs for current grant

Other

If checked other, please describe:

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PI's Name:

What is the project title?

IRBNet number (if applicable):

What is the project funding source?

Please provide a brief summary of your study:

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Anticipated/Actual Dates of Project

Start:

End:

At what phase is the study at currently?

Grant in preparation

Grant submitted, pending notice of award

Pending initial submission to regulatory committees for approval

Approved by regulatory committees, in study start-up phase (SOP development, piloting. etc.)

Open to enrollment/data collection

Closed to enrollment, in data analysis phase

Other

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Other:

Is a Core A leader or Core A staff person currently listed in your budget?

Staff listed:

Percent Effort listed at:

Yes

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Is a Core B leader or Core B staff person currently listed in your budget?

Staff listed:

Percent Effort listed at:

Yes

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Is a Core C leader or Core C staff person currently listed in your budget?

Staff listed:

Percent Effort listed at:

Yes

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Is your budget finalized?

Yes

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Regulatory Assistance

Please answer each question as best you can.

If applicable, what stage is the submission/IRBNet package in?

Not started

In discussion phase with study team

Regulatory documents are in preparation by PI and/or study team

Regulatory documents have been prepared and need a final review

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What committee(s) are you planning to submit to review your study?

IRB

R&D

Safety

IACUC

FDA

Unsure

Does the study involve human subjects?

Yes

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Are you planning to submit an Exemption Request?

(For criteria - Review the Exemption Request form under the VHA ORPP&E Library for Human Subjects Research in IRBNet)

Yes

Unsure if it meets criteria

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Will the submission involve a privacy or information security review?

Yes

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What is your anticipated submission date?

M-D-Y

If applicable, what is your study's expiration date?

M-D-Y

What type of review will your study receive?

Full Board Review

Expedited Review

Unsure

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Study Start-Up Request

Please describe your request for assistance starting up a study.

Do you need assistance with SOP development?

If applicable, have you completed mock sessions?

Do you need assistance with database set-up?

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What is your projected study start date?

M-D-Y

Space and Equipment Needs Request

Will you need space for personnel?

Yes

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If yes, how many people will you need a VA workstation for? How often will they be in the office?

Will you need additional space, besides the shared exam/interview rooms in B32, on campus to perform study activities?

Yes

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If yes, what space do you anticipate needing (Gait Lab, etc.) for the project?

How often do you anticipate using the space (1x/month, weekly, etc.)

What equipment are you requesting to use?

Please list the equipment and location of equipment.

Study Procedures and Visits Request

Please answer these questions to the best of your abilities. We will need to estimate how much time your study procedures/visits will take to determine the % time and effort of an RA will be needed to accomplish your request.

Please note: We will do our best to allocate appropriate resources, but we cannot guarantee a Core staff member will be available for the full time and effort requested/projected.

What type of study procedures will the RA assist with? (Select all that apply)

Recruitment/Screening

Consent

Clinical Assessments

Survey Collection (staff administered or self-reports)

Other

If selected other, please describe:

What level of involvement are you looking for the RA to have?

Fully run study visits

Assist PI/Co-I/other staff with visits

Assist with study procedure set-up

Be a back-up for study procedures in the case a study team member is sick/out for an extended time

Help with screening/referrals

How often do visits occur? How long is a typical visit (including set-up/break-down)? How many participants are you planning to enroll?

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Please estimate on average the time the RA will spend per week to complete the requested tasks.
(ex. screening medical records, visit prep/post activities, etc.)

Are there specific skills or certificates an RA will need to have to assist?

(For example: trained in specific clinical assessments, EEG certified, etc.)

Will an investigator or coordinator be present during study procedures?

Yes

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Data Entry Needs

What are you data entry needs?

Need assistance developing and/or testing a database

Need an RA to complete partial data entry

Need an RA to complete full data entry

How many participants do you have/plan to have data entry needs for?

How long on average will it take to complete for each participant?

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What type of data are you requesting help with?
(ex. self-reports, clinical assessments, etc.)

What is your timeline for completing data entry?

Staff Training Needs (New and Current Staff)

Is the staff member new or current employee?

New

Current

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Has the employee been through any training?

If yes, please describe:

What is the employee's role on your study/in your lab?

If any, what specific topics are you requesting training on?

When would you like the training to be completed by?

M-D-Y

Monitoring Visit Needs

Who is requesting to audit your study?

What is the reason for the audit?

Are you requesting the Regulatory Manager, Alison Gorbatov, to be present at the audit?

Yes

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Planned start date of audit

M-D-Y

Planned end date of audit

M-D-Y

Internal Study Audit Needs

Internal Audit: what would you like audited?

Screening/Consent documents

Source documents

Data entry

SOP/study procedures

Full study audit

Other

Is there any information that you would like to share regarding the audit? Are you aware of any any problem areas that need to be addressed?

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What is your timeline for conducting an audit? Would you like to set up a reoccurring audit?

DTUA/Tech Transfer Request Needs

Please describe your DTUA or Tech Transfer Request

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If applicable, does your ICF and/or protocol describe the data sharing procedures at this time?

Yes

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FDA/IND Submission Needs

Please describe your FDA/IND Submission Needs:

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Is there any additional information you would like to provide with your request?

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If available, please upload any applicable documents to be reviewed by Core staff to help assess the requested service.

Upload file

What is your general availability to meet if needed?

Would you prefer to meet in person or virtually?

In-person

Zoom

Teams

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Thank you for your Core Service Request! Please click the submit button below.

If you have any additional questions or would like to reach out regarding your request, please contact Alison Gorbatov, JD at Alison.Gorbatov@va.gov.

Completed survey

Upload file

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Core Resource Request

CfNN Core Service Request

Assessment, Outcome Measurement, and Implementation Core

General Project Information

Study Start-Up Request

Space and Equipment Needs Request

Please answer these questions to the best of your abilities. We will need to estimate how much time your study procedures/visits will take to determine the % time and effort of an RA will be needed to accomplish your request.

Data Entry Needs

Staff Training Needs (New and Current Staff)

Monitoring Visit Needs

Internal Study Audit Needs

DTUA/Tech Transfer Request Needs

FDA/IND Submission Needs

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