Below are CTTI-developed tools that can improve the quality and efficiency of your clinical trials today. CTTI's tools are created to facilitate the adoption of our official recommendations. These recommendations are based on evidence generated by engaging all stakeholders involved in the clinical trial process.
Single IRB Adoption Resources
A suite of new resources has been developed to facilitate the implementation of single IRB (sIRB) in multicenter trials:
CTTI Prioritization Tool for Sponsors and Patient Groups
CTTI launched a new tool at the 2019 DIA Global Annual Meeting that will help sponsors and patient groups identify high-value opportunities to collaborate.
Interactive Database of Feasibility Studies for Mobile Clinical Trials
CTTI has established a searchable online database of pilot studies that assess the feasibility of various mobile technology solutions. The Interactive Database of Feasibility Studies for Mobile Clinical Trials is the first publicly available resource that contains a catalogue of published feasibility studies related to the use of mobile technologies in clinical research.
Optimizing Mobile Clinical Trials by Engaging Patients and Sites
CTTI’s Mobile Technologies recommendations and resources address the challenges that previously hindered the use of mobile technologies in clinical trials. With this new comprehensive guide, stakeholders across the clinical trials enterprise can start to benefit from the potential advantages of using mobile technologies—including capturing “real world” data from patients, reducing barriers to participation, and lowering costs.
Detailed Description of Steps for Novel Endpoint Development: Table providing a detailed description of the steps for novel endpoint development, including suggested approaches, considerations and links to tangible examples in the use cases
Quick Reference Guide: Guide to processes for interacting with the FDA regarding novel endpoint development
PowerPoint Slide of Positive Impacts: Use this ppt slide in your presentations (Note: This information is also included in the first page of the Recommendations.)
Use Cases for developing novel endpoints generated using mobile technology:
Primary Users: Research Sites, Research Coordinators and Investigators, Research Sponsors, CROs, IRBs, Patients
The following tools were developed by the Informed Consent project team to assist researchers (at the site and sponsor) in using CTTI's recommendations to improve the informed consent process. These tools, which are included as appendices of the recommendations document, are available below in editable formats that may be customized to meet your organizational needs.
Tool 1. Informed Consent Discussion Tool (Word)
Researchers can use this tool to guide conversation during the consent process, ensuring the specific needs of each study participant are considered, key elements of the trial are reviewed and addressed, and interactive techniques are used to facilitate participant understanding of the information imparted. This tool could be used for documenting the informed consent process, but should not be viewed as a regulatory compliance document.
Tool 2. Informed Consent Training Resources (Word)
Research sites can use this tool to evaluate external informed consent training resources to determine if the resource meets the needs of the site’s training program.
Tool 3. Sample Tiered Informed Consent Model (Word)
Research sites, research sponsors, CROs, and IRBs can use this tool to better understand the basic structure of the Tiered Informed Consent Model document. It is not intended to be an informed consent document template.
Tools for Effective Engagement with Patient Groups (PGs) around Clinical Trials
Primary Users: Patient Groups, Research Sponsors, Investigators, CROs, Research Coordinators and Sites
The following tools were developed by CTTI’s Patient Group Engagement Project to assist research sponsors in assessing patient groups as potential partners in research and development, and to support patient groups in making their relevant assets and expertise transparent to sponsors. These tools, which are included in the appendices of the recommendations document, are available below in editable formats that may be customized to meet your organizational or project needs.
Tool 1. PG Organizational Expertise and Assets Evaluation Tool (Excel)
Sponsors can use this tool to analyze a PG's skills and strengths as relevant to research and development projects or clinical trials. PGs may also use the tool for strategic planning or to communicate their organizational capabilities and assets.