EAST Multicenter Study Proposal (revised January 2025)

Proposal forms must be completed in its entirety, incomplete forms will not be considered.

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Please refer to the following .pdf documents to complete the application.  The sections for each .pdf are noted below.  Those that do not follow the requests format will not be accepted:

The Specific Aims Narrative Instructions document can be found here.
The Approach Section Instructions document can be found here.

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When completing the form leave out identifying information (i.e. PI, institution, city, state, etc.)

Please indicate if this is a...*

• New MCT proposal submission
• Revised MCT proposal submission

If a revised proposal, upload response(s) to reviewers questions.

Accepted Formats: .pdf, .doc, .docx, .png, .jpg

If a revised proposal, upload revised proposal with highlighted changes.

Accepted Formats: .pdf, .doc, .docx, .png, .jpg

If a revised proposal, upload revised proposal without highlights.

Accepted Formats: .pdf, .doc, .docx, .png, .jpg

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General Information

Study Title*

Primary Investigator:*

Institution that will be the primary site for the study: *

Email of Primary Investigator:*

Co-PI/second point of contact for the study:

Email of Co-PI/second point of contact for the study:

Are you a current member of EAST?*

• Yes
• No

If you selected "No" above please identify a Sponsor that is an active EAST member:

If you need assistance in finding a Sponsor please contact Rachel Dixon at rdixon@east.org.

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Specific Aims

Provide a 1-page narrative. Items to be included can be found in the .pdf above.*

Accepted Formats: .pdf, .doc, .docx, .png, .jpg

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Research Strategy

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If no specific interventions are required and this is only a retrospective or prospective observational study, include that language here. Such as: “Prospective observational study only. Patients will be managed according to surgeon’s discretion.”

Significance: What gap in knowledge does the study address?*

Innovation: How does the study challenge or improve current understanding of the topic of interest?*

Approach: Items to be included can be found in the .pdf above.*

Accepted Formats: .pdf, .doc, .docx, .png, .jpg

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Logistics

# of sites expected to recruit & # of patients contributed per site:*

The data collection tool to be utilized for the study:*

If you require examples please visit http://www.east.org/research/multicenter-trials

Identify the individuals that will primarily be responsible for data collection process: *

PI, fellows, residents, med students, rsrch. coordinator, rsrch. assistance, clinical rsrch. nurse

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Human Subjects, Resources & Environment

Has IRB approval been obtained at the Primary Site?*

• Yes
• No
• IRB approval process has began but is not completed.

Is a DUA required for participation in the Study?*

• Yes
• No

If applicable, list the primary contact (name/email) to contact to initiate & execute DUA:

Does the study require informed consent? (If so, outline the consent procedure below.)*

• Yes
• No

Consent procedure:

If applicable.

Does the study require funding? *

• Yes
• No

If so, what is the source of funding? Will funding be available at the time of MCT initiation?

Outline what resources are available to you to ensure the study will be completed.*

Characteristics & resources of the study institution, available research infrastructure & support.

Is this study being actively reviewed or in review by any additional surgical societies?*

• Yes
• No

Statistical plan/data analysis developed with the assistance of a statistician:*

• Yes
• No

If "No", why?

Statistical support available to the PI to perform the analysis at the completion of the study:*

• Yes
• No

If "Yes", who will be analyzing the data?

If "No", what is the PIs plan to run the analysis at study completion?

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References

Include a brief listing of key references:*

With DOI to allow easy access. Vancouver style.

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Instructions for submitting data collection tools:

All data submissions should be entered through the EAST Multicenter Trial Committee website portal.  Instructions can be found on the EAST website.  The data collection sheet located under the Multicenter Trial Committee heading for this study can be utilized to record the data, and then the information transferred to the portal entry system.  For any questions regarding this study, please contact the PI.

Questions?  Please contact EAST Management Office at (312) 202-5616 or rdixon@east.org.