Trial Innovation Network (TIN) Resources
The DMCC will serve as a connector for RDCRN consortia to obtain complementary project resources/support from the Trial Innovation Network (TIN), which was formed through the NIH/NCATS’ Clinical and Translational Science (CTSA) Program, in order to streamline and improve multi-site clinical trial processes, thereby enabling research to be conducted in a more rapid, cost-effective manner (for more information on services and tools offered by the DMCC, please check out our website). The TIN is comprised of three key components with respective support functions that promote clinical trial readiness: i) Trial Innovation Centers (TICs) that lead operational support and innovation for trial setup and management, ii) a Recruitment Innovation Center (RIC) that develops and implements evidence-based approaches to enhance participant recruitment and retention, iii) CTSA Program Hubs that are academic centers for facilitating and supporting researchers on a local level. The Cincinnati Children’s team is a partner in the ECSTATIC TIC and can help connect RDCRN consortia with TIN’s services, which will be available to complement the DMCC efforts. Examples of TIN’s services include protocol development, study operations enhancement, trial budgeting guidance, regulatory agreements, clinical coordination & management, data safety & monitoring, and guidance for study design/analytic approaches & analysis plans. For additional information on this important resource, please reach out to rd.dmcc@cchmc.org.
Most utilized TIN resources
TIC Resources
Standard Agreements: To improve the efficiency of the process for review and negotiation process for research agreements, the CTSA Program hubs and the Federal Demonstration Partnership (FDP) have developed a toolkit of standardized agreements and FAQs for use by the TIN.
Single IRB: One institution (the sIRB) serves as the IRB of record that oversees all clinical trial sites participating in a multi-site study. The goal is to reduce bottlenecks caused by multiple IRBs reviewing the protocol and consent documents for the same study.
IREx: Freely available web portal for single IRB review documentation and coordination
Regulatory Support (for IND submissions): The Investigational New Drug (IND) Regulatory Support team is a multidisciplinary team with expertise in the regulatory and submission process for obtaining an Investigational New Drug (IND) application through the Food and Drug Administration (FDA). (see also resources provided by the RDCRN DMCC)
REDCap Central: 21 CFR Part-11 Ready Environment - The purpose of this innovation is to:
Support researchers conducting trials that need an FDA-compliant EDC cloud environment to manage sensitive and regulated data
Provide a cost-effective solution that removes the burden of extensive local IT infrastructure
Provide study teams access to guidance and support from VUMC experts to educate and assist with maintaining system compliance
Provide limited technical support to study teams via training and access to SOPs.
Ensure electronic regulatory compliance for REDCap LTS upgrades
e-Consent: The system uses REDCap, which provides both a portable and a scalable platform which can be utilized and shared across study sites. Specifically, the platform enables users to embed images within projects, allowing consent documents to be tailored to the demographics or needs of specific participant populations. Additionally, comprehension questions and branching logic can be built into consent documents to assess patient understanding of the study and to provide “real-time” feedback/clarification to users. (see also resources provided by the RDCRN DMCC)
REDCap Randomization module: The module is expected to enhance sampling flexibility, improve trial safety and efficiency, thereby enhancing trial validity while reducing staff time and trial costs.
MyCap: MyCap is a participant-facing mobile application for survey data collection and the automated administration of active tasks (activities performed by participants using mobile device sensors under semi-controlled conditions). MyCap is a no-code solution for research teams conducting longitudinal studies, integrates tightly with REDCap and is available at no cost to research teams at academic, nonprofit, or government organizations. (additional information)
Study Planning (Budget): Clinical trial budget experts will provide an evaluation and recommendations on the budget, including:
Estimates for the overall study budget
Estimates for the site/subject budget
Estimates for a recruitment budget (if applicable)
Study Planning (Design): Identify potential barriers and solutions for study goals, interventions, methodology, statistical plan, and regulatory approaches.
Study Planning (Feasibility and Timeline): Feedback on the proposed funding mechanisms or alternatives, submission timeline feasibility, and overall study conduct
Other tools referred to as “innovations” (i.e., tools that are operational, but we’re just piloting them when the study is a good fit:
Budget Feasibility Tool: used in conjunction with the expression of interest (EOI – see RIC tools below) to support sites in determining whether the proposed budget is feasible for their site.
Clinical Data Interoperability Services: is an advanced feature of REDCap that must be enabled by a REDCap administrator. This feature allows an individual REDCap project to interact with an electronic health record (EHR) such as EPIC, Cerner, etc. and pull selected information from the EHR into the REDCap project. This is done through the Fast Healthcare Interoperability Resources (FHIR) web service inside of an EHR which can pull structured data into REDCap using OAuth2 authorization.
REDCap Rapid Validation: REDCap Central is a data collection tool hosted in a secure, compliant cloud server managed by VUMC. Key features include: audit trails, user management, and electronic signatures. The purpose of this innovation is to:
Support researchers conducting trials that need an FDA-compliant EDC cloud-environment to manage sensitive and regulated data
Provide a cost-effective solution that removes the burden of extensive local IT infrastructure
Provide study teams access to guidance and support from VUMC experts to educate and assist with maintaining system compliance
Provide limited technical support to study teams via trainings and access to SOPs.
Ensure electronic regulatory compliance for REDCap LTS upgrades
RIC Resources:
Community engagement studio: This consultative method allows for meaningful involvement of diverse groups of stakeholders in the planning and implementation of research. Studios can facilitate guidance on identifying and addressing barriers to participation and how to develop or refine recruitment materials and messages. Key features:
Assessment of whether a studio is appropriate for your study and if so, where it has the potential to add the most value
Advice on when and how to conduct studios
Recruitment Planning: An effective recruitment plan includes strategies to identify and engage specific population(s), including how to communicate and engage potential participants and meet realistic enrollment and retention goals. Key features:
Comprehensive review of your study and existing recruitment plan
Identification of stakeholders and recruitment partners (such as providers and community organizations) as well as recruitment locations
Guidance on understanding the unique needs and preferences of potential participants as well as barriers and facilitators to recruitment and retention
Tailored recommendations for engaging participants from your study population
Recruitment Feasibility Assessment: This process evaluates the possibility of recruiting an adequate number of participants with the appropriate range of characteristics (such as age, gender, race, ethnicity, and health status) to meet enrollment goals on the projected timelines and costs. The assessment considers environmental strengths and weakness (such as location, competition, prior success recruiting, and potential participant pool) as well as logistical, motivational, and behavioral barriers to recruitment and retention. Key features:
Comprehensive review of your study and budget
Assessment of the likelihood your study will meet predefined recruitment and retention goals
Tailored advice on how to enhance feasibility
Recruitment materials: Materials may include written or verbal communication delivered through a range of multimedia channels and platforms to increase enrollment. Key features:
Review of materials needs, including dissemination plans
Recommendations and templates that might improve the recruitment of potential participants for specific studies
EHR-based cohort assessment: This resource helps investigators consider ways to use Electronic Health Record (EHR) data to inform study design and potential site selection. Expect expert clinical and technical review of a study’s goal recruitment population and high-level assessment of computable phenotyping. Funded projects may also request support to organize the distribution of phenotype algorithms to potential CTSA Program sites and collate results.
Expression of Interest (EOI): An Expression of Interest (EOI) is a formal outreach from the Trial Innovation Network (TIN) to CTSA sites announcing a possible trial opportunity. The EOI is intended to provide CTSA sites, their affiliates, and partners, with opportunities to participate in potential trials through a TIN-developed outreach model. In this model, the TIN acts as the intermediary between the study-PI and the CTSA site. The TIN will work directly with the study team to develop a formal outreach which may include a request for sites to determine feasibility of study protocol and/or site budget, conduct an EHR-based Cohort Assessment to assess available recruitment populations, and identification of a local site investigator. Sites receiving the outreach request will have the opportunity to respond with the requested information or opt-out of the opportunity. The TIN may also provide support with further site assessment, selection, and activation of study sites.
Research Match (RM): aligning volunteers with researchers and studies across the US.
RM Expert Advice tool: survey volunteers to confirm feasibility of study design/procedures
Clinician Study App (CSA): an electronic study info card serves as a recruitment tool: key study information; quickly connect patients with key study contacts; study teams design and maintain their own CSA.