Guidance Toolkit User Guide

The Toolkit User Guide provides a brief introduction to the types of tools included in the Toolkit. Additional context is provided within many of the tools on how they can be used or adapted, and the audience for each.

If you need additional instruction, please feel free to contact the MRCT Center at

What are logic models?

A logic model is a visualization of a program or initiative. Logic models present the relationships between inputs (resources), activities, outputs, outcomes, and the desired impact of the program.

The logic models are available for download as PDFs, including editable PDFs that allow for the text to be modified. There is also a blank PDF template included in the Introduction category of the Toolkit for situations that were not addressed via a logic model in this Toolkit.

What is the purpose of logic models in the Diversity Toolkit?

The logic models describe activities proposed throughout the Guidance Document in discrete frameworks. Along with the proposed indicators, the logic models should help in considering measurement of diverse inclusion activities.

When using these logic models, consider:

  • These are directional and non-exhaustive.
  • While the audience has been defined for each logic model, this should not limit its use more broadly.
  • The scope of activities varies across each logic model provided.
  • Each logic model can be adapted to the unique needs of different programs. The blank and editable logic models are provided for this purpose.
  • In translating logic models to performance indicators, it is important to define key terms that are used.
  • These logic models may overlook some interdependence and shared responsibility among different stakeholders and between domains of the clinical research enterprise.
  • Logic models may be linked, as the outcomes of one logic model might provide the inputs of another (e.g., study design materials required during study conduct and recruitment).

More details on how to use these logic models can be found in the introduction of the Toolkit.

What are Key Performance Indicators?

Key performance indicators (KPIs) are measurable information used to determine if a program or initiative is being implemented as expected and achieving its desired effects. Examples of KPIs include the proportion of leadership from underrepresented backgrounds, the demographic distribution of trial participants, or the level of input on study materials received from patients.

What is the purpose of KPIs in the Diversity Toolkit?

In this Toolkit, KPIs have been proposed to accompany each logic model. KPIs can be developed for any component of a logic model. For example, they can measure whether an activity’s output has been achieved, or whether its long-term outcome has been achieved. In either case, KPIs can be based directly on the logic model to measure the conduct, progress, and effects of a program.

KPIs are not exclusively limited to use alongside logic models, but we encourage the use of the two together within this Toolkit, and for program planning and evaluation in general.

The KPIs are available for download as PDFs.

What is a checklist?

A checklist is a simple document providing action items or tasks in list format. Checklists should be clear, straightforward, and follow a logical build.

What is the purpose of checklists in the Diversity Toolkit?

Checklists are offered throughout the Toolkit to help set priorities, standardize processes, map out an approach, etc. They are available for download as PDFs.

These checklists can serve as a starting point for certain initiatives. We encourage organizations to adapt the lists to fit an organization’s needs and/or to a specific protocol, as necessary.

What is a document template?

A document template is a guide, or a boilerplate, for the development of a document.

What is the purpose of document templates in the Diversity Toolkit?

Templates are intended to serve as a guide. The format and sections should be revised, as necessary, to reflect the specific objectives and challenges of any given study and its protocol.

There are numerous templates offered in the Diversity Toolkit, particularly in the Study Design, Conduct, and Implementation category. They are available for download as PDFs and as Word Documents.

What is a Decision Tree?

A decision tree is a support tool that aids decision making. Decision trees are often structured as flow-charts, with each decision or test point branching in different directions based on the decision or outcome of the test.

What is the purpose of decision trees in the Diversity Toolkit?

Decision trees are intended to help in an approach to a problem, setting out an order for consideration. These are intended as frameworks and should be adapted for the specific use or application.

For instance, in this Toolkit, the Feasibility Decision Tree is structured to offer help with a comprehensive assessment of varying capacities of a single site. The framework:

  1. Assesses the feasibility of sites to enroll a diverse population but does not provide specific methods for that assessment.
  2. Provides thematic areas, but does not provide fixed criteria to determine a site’s capacity for diverse enrollment. In fact, it incorporates multiple “checkpoints,” at which the user can reconsider the capacity of a site.

More details on how to use this tool can be found in the Toolkit.

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