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Required format:

CTSI Trial Innovation Network (TIN) Request Form

Returning?

A A A

Please complete the form to request TIN Services

If you have any questions, please contact:

Keith Brown, Project Coordinator, Investing in Translational Research

keith.brown@nyulangone.org

Prinicipal Investigator Name

(Last, First, Middle)

* must provide value

Kerberos ID (Please enter N/A if you do not have one)

eRA Commons User Name (Please enter N/A if you do not have one)

Gender

Are you Hispanic (or Latino)?

What is your racial background?
(Please check all that apply)

American Indian/Alaska Native

African American

Asian

Hawaiian/Pacific Islander

White

Other

Do not wish to provide

Degree(s)

* must provide value

Title

* must provide value

Full Professor

Associate Professor

Assistant Professor

Instructor

Medical Fellow

PhD Fellow

Other

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If other title, please specify

Primary School/Institute Affiliation

* must provide value

If NYULH, please specify which department:

If Medicine, please specify which division:

If NYULH Institute/Center, please specify which institute:

If NYC H+H, please specify which facility:

If Other, please specify:

Telephone

* must provide value

Email Address

* must provide value

What is the title of the Trial Innovation Network Project Proposal?

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What is the short title for the Trial Innovation Network Project Proposal?

* must provide value

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What is the phase of this study? (Phase I, Phase II, Phase III, NA)

* must provide value

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Provide a short description of the protocol, including a brief statement of the study hypothesis. This should be only a few sentences in length:

* must provide value

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Provide a Provide a brief description of the manner in which the trial will be conducted including, if
applicable:

For interventional trials: the primary purpose of the intervention, the study phase, the strategy for assigning interventions to participants (cross-over, single group, etc.), the number of arms, allocation of participants to each arm, masking/blinding.

For observational studies: the primary strategy for participant identification and follow-up, temporal relationship of observation period to time of participant enrollment (prospective, retrospective, cross-sectional, other), biospecimen description and retention, target follow-up duration, and number of cohorts.

* must provide value

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Insert objectives that are the same as the objectives contained in the body of the protocol. Include the primary objective and secondary objectives.

* must provide value

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Insert endpoints (e.g., outcome measures) that are the same as the endpoints contained in the body of the protocol. Include the primary endpoint and secondary endpoints.

* must provide value

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Specify sample size, gender, age, demographic group, general health status, geographic location

* must provide value

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Provide the main inclusion and exclusion criteria.

* must provide value

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Provide a brief description of planned participating sites. Indicate the approximate number of sites and if the study intendeds to include sites outside of the United States.

* must provide value

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DESCRIPTION OF STUDY INTERVENTION
If the study intervention is a drug or biologic, include dose and route of administration. For devices provide a description of each important component, ingredient, property and the principle of operation of the device.

* must provide value

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STUDY DURATION
Estimated time (in months) from when study receives funding (can include planning year) to completion of data analyses.

* must provide value

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PARTICIPANT DURATION
Estimated time (e.g., in months) for each individual participant to complete all participant visits.

* must provide value

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DISCLOSURES/CONFLICTS
In this area, please briefly disclose any financial ties or other conflict of interest you or your team/organization may have related to this study. If none, please state so.

* must provide value

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STATISTICAL PLAN (optional)
In this area, please describe the statistical plan.

* must provide value

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ENROLLMENT PLAN (optional)
Please enter a brief description of your enrollment plan. When do you expect the first site to be initiated and how long before all sites are actively recruiting (Months-to-Activate)?

Approximately how many subjects will each site enroll per month during the enrollment period (RND/Site-Month)?

Approximately how long will it take to enroll the planned number of subjects?

Please explain your calculations and if based on any previous study performance data.

* must provide value

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What is the therapeutic area of your study?

* must provide value

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Is this a rare disease study? (If you are not sure, please click here to view the NIH definition of "rare disease").

* must provide value

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What is the estimated number of subjects?

* must provide value

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What is the study population?

* must provide value

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What is the estimated number of sites?

* must provide value

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What is the number of non-US sites? List those countries:

* must provide value

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Upload list of participating sites if available

* must provide value

Upload file

What is the number of CTSA Program sites?

* must provide value

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FUNDING/SUPPORT FOR THE PROPOSAL
Requests for Trial Innovation Network Initial Consultation should include the following characteristics:
• A strong hypothesis that is outlined in the proposal
• A multi-center study design
• A potential funding source identified

During an initial consultation, the assigned TIC/RIC and study investigator have a series of meetings to discuss potential topics such as the underlying scientific premise, primary and secondary outcomes, or statistical analyses approaches of the proposed study. Partnering with the Network will connect you with experienced clinical trialists and experts in recruitment.

The Network will also focus on operational innovation and will leverage the expertise and resources of the CTSA Program. As the initial consultation progresses, discussions between the study investigator and TIC/RIC may narrow to other relevant issues specific to the study, such as: Study Planning, Recruitment & Retention Planning, Innovations & Clinical Effectiveness Trial Design.

The Trial Innovation Network will prioritize proposals that provide an opportunity to test an operational hypothesis and those proposals with funding available to support the requested resource(s).

Has this study ever been submitted to an NIH
I/C?

* must provide value

Yes

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Has your study/trial been funded?

* must provide value

Yes

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How many funding sources?

* must provide value

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What is the planned funding source for the study/trial?

* must provide value

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Where are you seeking funding for the study/trial?

* must provide value

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Do you anticipate a budget > $500,000 in direct costs per year?

* must provide value

Yes

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What is the anticipated total budget (indirect and direct)?

* must provide value

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What is the total duration of the funding period?

* must provide value

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What is the anticipated funding start date for this application?

* must provide value

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If applicable, by what date do you need to submit your application to your institution's business office?

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Will this proposal involve a partnership with a new or existing network? If yes, list the partnering network:

* must provide value

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Has this study/project undergone a scientific peer review?

* must provide value

Yes

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What is the reviewing university/organization? Please note, peer review is not IRB review. If reviewed by another organization, please describe the review and the composition of the review committee.

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TIMELINES
Date planned for final protocol?

* must provide value

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Date planned for first site activated?

* must provide value

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What is the grant submission deadline?

* must provide value

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INITIAL CONSULTATION
The Trial Innovation Network will provide an initial consultation for your proposal. Please choose the topics you would like to discuss:

* must provide value

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ATTACHMENTS
Please include any study materials like a protocol or study synopsis via e-mail.

Upload file

Attachment 2 (optional)

Upload file

Attachment 3 (optional)

Upload file

Attachment 4 (optional)

Upload file

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