EAST Multicenter Study Proposal

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

Please indicate if this is a...*

• New MCT proposal submission
• Revised MCT proposal submission

If a revised proposal summarize the changes made to this proposal based on the feedback received:

Based on the comments provided by the EAST MCT Cmte.

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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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Background & Significance

Use this area to briefly outline the burden of the problem to be examined.*

Briefly review what major published studies exist on the topic of the proposed project.*

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Innovation & Impact

Use this area to briefly outline how this idea is innovative and it's anticipated impact.*

Describe what & how the proposed MCT will add to the existing body of knowledge & literature.*

Please describe briefly.

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Specific Aims/Hypotheses

Primary aim*

Primary aim should be succinctly stated here – single sentence ideal

Secondary aims

Any secondary aims should be stated here

Tertiary aim

Optional

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Methods

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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.”

Design*

• Prospective (observational with or without consent requirement)
• Retrospective

Inclusion Criteria*

Exclusion Criteria*

Please describe, completely but succinctly, how the project will be conducted.*

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Outcomes Measures

Primary Outcome*

(List here)

Secondary Outcome(s)*

(List here)

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Variables To Be Collected

Select the variables to be collected & analyzed:*

• Baseline Participating Institution Information
• Demographics
• Baseline Clinical Characteristics
• Hospital Course
• Treatments & Interventions
• Outcomes of Interest
• Additional variables noted below:

Additional variables:

If applicable.

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Data Collection

Outline the data collection plan/tool succinctly*

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

Has IRB approval been obtained at the primary site?*

• Yes
• No

Is DUA required for participation in the study?*

• Yes
• No

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

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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Statistical Considerations & Data Analysis

Is there a primary statistician assigned to assist the PI w/design & data analysis?*

• Yes
• No

If no, how was study design/power analysis determined/who will handle analysis once complete?

Include detailed description of the data analysis plan: *

Including parametric & non-parametric tests used to handle the data.

Include Power Analysis:*

Anticipated # of sites needed to participate & estimate of ave. # of patients enrolled per site.

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Enrollment Procedure & Need for Informed Consent

Please note what your enrollment procedure for this study entails:*

Outline consent procedures here, if applicable:

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Primary Site Resources

Please indicate what resources are available at the primary study institution:*

• Presence of a dedicated statistician
• Research personnel
• Availability of data collectors

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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.