The Trial Innovation Network is a resource for investigators to request services or consultations for multi-center clinical trials and studies. 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.
We look forward to receiving your proposals and collaborating with you to build an unprecedented national platform for clinical trials that will have a significant impact on public health. Please visit this site frequently for updated information.
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.
Please read the information in each section below for important information about Services and Consultations including descriptions of each.
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.
Listed below are services provided through the Trial Innovation Network and what to expect for each. Investigators may select services through the proposal submission process.
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.
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.
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:
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:
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:
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.
Listed below are the initial consultation options provided through the Trial Innovation Network and what to expect for each. Investigators may select an initial consultation through the proposal submission process.
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.
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.
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.
The Trial Innovation Network will assess recruitment strategies. At the conclusion of an initial consultation an assessment of study recruitment will be provided.
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.
Please read the information in each section below for important information about the Trial Innovation Network Proposal Process.
Please see the Proposal Submission Resources for more information on submitting a Network proposal.
Proposals can be submitted at any time. They will be reviewed by the Protocol Assessment Team on a rolling basis.
Investigators should submit proposals electronically through the Trial Innovation Network website. Chrome is the recommended browser for submitting a proposal.
After your proposal is submitted to the Trial Innovation Network it will be reviewed by the Proposal Assessment Team.
The Trial Innovation Network is rapidly evolving and developing. Our goal is that the Trial Innovation Network becomes a resource for the scientific community that will foster excellence and innovation in clinical trials and studies.
Chrome is the recommended browser for submitting a proposal
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