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.
Pregnancy Testing Outcomes Predictor for Clinical Trials
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.)
Uses Cases for for developing novel endpoints generated using mobile technology:
Tools for Efficient and Effective Clinical Trial Recruitment Planning
The following tools were developed by CTTI's Recruitment Project in tandem with the official Recruitment Recommendations (FULL VERSION and SUMMARY are available). These tools are linked to in the recommendations document, and are also listed below for convenience.
Tool #1. Decision Tree
A helpful decision-making aid to use when engaging with stakeholders in study design & development
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 Groups & Clinical Trials 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.
Primary Users: Anyone interested in designing and conducting clinical trials
The Quality by Design Project identified a need among clinical researchers for resources to support establishing and sustaining Quality by Design (QbD) within their organizations. To address this need, CTTI has developed a QbD toolkit that includes resources for researchers first learning about QbD concepts, to those who are ready to fully implement QbD into a clinical trial. Components of the toolkit include 1) an introduction to QbD concepts, 2) tools for teaching others in your organization about QbD and its use, and 3) tools for operationalizing QbD in your next clinical trial, including an interactive QbD Principles Document, a description of principles for building quality into trials, intended as a tool for inquiry in “critical to quality” factors (CTQs) and associated risks.
*Click here to view the CTTI recommendations associated with this toolkit.
Implementation Tools for the Use of a Single IRB of Record
Primary Users: Sponsors, institutions, and organizations that serve as a central IRB
CTTI has recommended the use of a single IRB of record for multi-center clinical trials. To facilitate adoption of this model, CTTI has developed the following tools and resources.
Evaluation Checklist
The purpose of this document is to assist organizations with adoption of a central IRB (a single IRB of record for all sites) model for multi-center clinical trials.
Template IRB Authorization Agreement
This template IRB Authorization Agreement (IAA) is intended to address an administrative concern about using a single central IRB for multi-center clinical trials.
Considerations Document
To address blurred distinctions between responsibilities for ethics review and other institutional obligations, CTTI recommends that sites and IRBs use the CTTI-developed guide (aka Considerations Document) to support communication and contractual relationships between institutions and a central IRB.
*Click here to view the CTTI recommendations associated with these tools.
AACT Database
Primary Users: Researchers interested in analyzing data from clinical trials
Using publicly available and downloadable data from ClinicalTrials.gov, CTTI's State of Clinical Trials Project developed a restructured and reformatted relational database. This is referred to as the database for Aggregate Analysis of ClincalTrials.gov (AACT). The purpose of AACT is to make the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. Data from this database has been used to analyze the portfolio of clinical trials in several specific therapeutic areas. For more information on this database, including download instructions, click here.