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.

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.