Multi-Site Trial Protocol Development Assistance
This service is provided by the Trial Innovation Network Hub Liaison Team.
Overview
The Irving Institute's Hub Liaison Team to the Trial Innovation Network helps Columbia University clinical trialists and researchers to develop, fund, and implement clinical trials in the most efficient manner. Through the Multi-site Trail Protocol Development Assistance service, our hub team coordinates with the national network and the three Trial Innovation Centers (Duke University/Vanderbilt University, University of Utah, and Johns Hopkins University/Tufts University) to provide an opportunity to propose and develop clinical trial research grants and protocols for submission to the National Institutes of Health (NIH) or other major funders. The Hub Liaison Team can provide help with any or off of the following:
- A study design core that works with investigators to develop robust protocols and feasible study budgets
- A study start-up core that establishes master clinical trial agreements and oversees a central Institutional Review Board (IRB) to get the trials underway as quickly as possible
- A study conduct core that provides support to investigators from initial trial design to dissemination of results
- Support for rapid establishment of a single IRB and streamlined contracting for trials
- Support for the development and implementation of practical study protocols within feasible budgets
- Support for randomized drug trials, including industry-sponsored trials
- Fully operational single IRB and institutional master agreements
- A multidisciplinary, multi-stakeholder infrastructure and process that infuse innovation into future trials
Starting in March 2020, we are also providing support for COVID-19 research.
Eligibility
This service is available to all researchers/clinical trialists at Columbia University.
When to Request This Service
This service can be requested at any time. It will typically require at least six months for a study proposal to be developed for NIH submission. The timeline will be determined together with the Trial Innovation Center (TIC) after initial proposal submission on the Trial Innovation Network website.
Cost
There is no cost for this service.
Cite it, Submit it, Share it!
If your research has benefited from one or more Irving Institute resources, please remember to:
- Cite our CTSA grant, UL1 TR001873, in any relevant publications, abstracts, chapters, and/or posters.
- Submit your publications to PubMed Central (PMC) for compliance with the NIH Public Access Policy.
- Share your research updates with us by sending an email to: irving_institute@cumc.columbia.edu
