Proposal submission opens on November 16, 2016

Information updated as of 2/23/2017

Investigators are invited to submit proposals to the Trial Innovation Network. Proposals can be submitted at any time. They will be reviewed by the Proposal Assessment Team on a rolling basis.

Proposals may include a request for a Service or an Initial Consultation. Please note that there will be two separate forms for proposals – one form for proposals requesting a Trial Innovation Network Service and one form for proposals requesting a Trial Innovation Network Initial Consultation.

Trial Innovation Network Services

  • If you are requesting a Trial Innovation Network Service, your study should already be funded or you should have already applied for funding. Service requests will be prioritized based on resource availability.

Trial Innovation Network Initial Consultation

  • If you are requesting a Trial Innovation Network Initial Consultation, your proposal should be in the development stage and not yet submitted for funding. A Trial Innovation Network Initial Consultation includes approximately 8-10 hours of consultation time with a TIC and/or RIC.

Trial Innovation Network Comprehensive Consultation

  • Based on the outcome of an Initial Consultation, the next step may be a Comprehensive Consultation. A Comprehensive Consultation cannot be selected by an investigator, but is a decision that is reached after the Initial Consultation and after approval by the Proposal Assessment Team and NCATS.
  • A Comprehensive Consultation involves mutual agreement and commitment by the investigator and the TIC/RIC to collaboratively develop the proposal into a protocol. In addition, one of the goals in the Comprehensive Consultation process is to obtain input from the CTSA Hubs on the protocol. The estimated number of hours of consultation time for a Comprehensive Consultation has not yet been determined.
  • After a Comprehensive Consultation, an investigator prepares a clinical trial application for submission to an NIH Institute for funding. The TICs/RIC would serve as the Coordinating Centers for the study and the CTSA Hubs would be potential sites.
  • If an application is funded, the proposed study would be implemented in the Trial Innovation Network using the TICs, RIC, and CTSA Hubs.
Services
(RIC/TIC may provide one of the following services)
What You Can Expect
Operationalize Standard Agreements The complexity of contract negotiations can be a major barrier to timely study start-up. With this service, we will provide recommendations on how to use the FDP-CTSA agreement. This Standard Agreement can potentially be used by each of the participating institutions in your multi-site study.
Operationalize Central IRB Recent policy changes by the NIH and DHHS require the use of a single IRB of record for multi-site research to reduce redundant IRB review and to streamline investigator submission processes.

The Trial Innovation Network has established three Central IRBs (CIRBs), which are based on the SMART IRB Authorization Agreement. This service will provide CIRB services to a funded multi-center clinical trial.

For each study, the Trial Innovation Network CIRB will also provide resources, tools, and a web-based platform (SMART IRB Exchange) to operationalize the CIRB. The goal is to ensure all site investigators understand the process for initiating the use of a CIRB at their local institution, as well how to submit and report to the CIRB from initial submission to study closeout.

Feasibility Assessment/ Recruitment Plan Assessing clinical trial feasibility includes evaluating the likelihood of successfully conducting a clinical trial in a particular geographical region. In addition, the assessment would include evaluation of how best to optimize timelines, recruitment targets, and cost. The Trial Innovation Network can also provide recommendations to improve both the feasibility of a study and engagement of participants.

Key features of this Trial Innovation Network Service include:

  • Reviewing study design
  • Assessing the likelihood of meeting pre-defined recruitment and retention goals
  • Providing advice and recommendations on recruitment strategies.
Recruitment Materials Recruitment materials may include any written or verbal communication delivered through a range of multimedia channels and platforms to increase enrollment.

Key features of this Trial Innovation Service include:

  • Reviewing recruitment material needs including any dissemination plans
  • Providing advice, recommendations and templates in order to improve the recruitment of potential participants for specific studies;
  • Sharing best practices
Community Engagement Studio A community engagement studio is a structured method of engagement that allows meaningful involvement of diverse groups of stakeholders. Engagement studios can be used to facilitate project-specific input including providing guidance and recommendations on how to develop or refine recruitment materials and messages.

Key features of this Trial Innovation Network Service include:

  • Assessing whether a studio might be appropriate based on the needs of a study and if so, where a studio has the potential to add the most value
  • Providing advice and guidance on when and how to conduct studios
  • Providing recommendations on how a studio can be used to develop and refine study messaging and materials.
Initial Consultations
(RIC/TIC may provide advice on any of the following)
What You Can Expect
Study Design The TIC and RIC will review of the submitted study material and discussion the proposed design. The discussions may involve the study goals and aims, the methodology, statistical and regulatory considerations, subject recruitment, schedule of assessments, study interventions, or other components of the study. The goal of these discussions is to help work through potential barriers to successful study completion.
Study Budget The Trial Innovation Network will provide recommendation on the budget as it relates to the proposed protocol. At the conclusion of an initial consultation an estimated budget based on the protocol design will be generated. The budget will include estimates for the overall study budget, site/subject budget, and a recruitment budget, if applicable.
Projected Timelines The Trial Innovation Network will provide a recommendation on Timelines for submission of the application as well as timelines for the overall conduct of the study, this includes planning, study start-up, conduct, close-out, and final publication, will be reviewed.
Recruitment The Trial Innovation Network will assess recruitment strategies. At the conclusion of an initial consultation an assessment of study recruitment will be provided.
Assessment of Study Feasibility The Trial Innovation Network will assess the   feasibility of the study being successfully completed within the proposed timelines and budget and note any potential barriers. The Trial Innovation Network will provide recommendation to optimize successful completion of the study within the proposed timelines and budget.

Proposal Submission Resources:

Checklist for Investigators
updated 2/14/17
View or Download
The purpose of this document is to provide guidelines and a checklist to study investigators interested in submitting a proposal to the Trial Innovation Network.
Checklist for Hub Liaison Teams
updated 2/14/17
View or Download
The purpose of this document is to provide guidelines and a checklist to assist Hub Liaison Teams in providing information to potential investigators about the proposal submission process.
Proposal Submission General Instructions
updated 2/14/17
View or Download
This document describes the Trial Innovation Network proposal assessment process and standards for confidentiality. It also provides guidelines and instructions to facilitate submission of proposals.
Trial Innovation Confidentiality Policy
View or Download
This document describes the Trial Innovation Network confidentiality and non-disclosure policy. It is expected that all proposals and accompanying information submitted to the Trial Innovation Network will be kept confidential.

Submit your proposal here.

 

Learn more about Trial Innovation Network Proposals:
Preparing To Submit A Trial Innovation Network Proposal
What Happens After You Submit A Trial Innovation Network Proposal