Implementation Tools

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

CTTI's Pregnancy Testing Outcomes Predictor for Clinical Trials is a web application that provides a quantitative method for assessing the estimated likely outcomes of different pregnancy testing plans.

Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

Download the Recommendations

In addition to the recommendations, a suite of tools have been developed to assist with implementation:

Resources for Planning for Successful Trial Recruitment

The following resources were developed by CTTI in tandem with the official Recruitment Recommendations.

  1. Decision Tree: How to Optimize Your Protocol Design
    A helpful decision-making aid to use when engaging with stakeholders in study design & development
  2. Customizable Table: How to Identify and Engage with Stakeholders
    A resource to help you identify and engage with stakeholders
  3. Checklist: How to Monitor Recruitment Process & Performance
    A tool to assist in considering how to monitor recruitment process and performance
  4. Considerations: Should I Include Patient Reported Outcomes (PROs) in My Study? 
    A guide when considering whether and/or how to include PROs in your study

Tools for Improving the Informed Consent Process

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.

*CLICK HERE to download the SPSS dataset for the resulting publication

Quality by Design Toolkit

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.