Analyses of Randomized Controlled Trials in the Presence of Noncompliance and Study Dropout
A working document from the Biostatistics and Study Design Core discussing missing data due to noncompliance and study dropout in an intention-to-treat analysis framework.

Communicating With Health System Partners During the Life Cycle of a Trial
A handout outlining points in a study when research teams may need to engage with health system leaders, clinic-level managers, and frontline staff.

Community Health Improvement in Pragmatic Clinical Trials
A handout designed to help research teams to help define community health in the context of pragmatic clinical trials and to provide examples of community health best practices in clinical research.

ePCT Quick Start Guide for Investigators
A guide designed for clinical investigators interested in learning how to conduct an embedded pragmatic clinical trial (ePCT).

Frailty Models in Cluster-Randomized Clinical Trials
A guidance document from the Biostatistics and Study Design Core on frailty models in cluster-randomized trials.

Intraclass Correlation Coefficient Cheat Sheet
An introductory description of the intraclass correlation coefficient (ICC), a descriptive statistic that is important for the design and analysis of cluster-randomized trials.

NIH Pragmatic Trials Collaboratory Fact Sheet
A double-sided information sheet about the NIH Pragmatic Trials Collaboratory.

Pair-Matching vs Stratifications in Cluster-Randomized Trials
A working document from the Biostatistics and Study Design Core about the advantages and disadvantages of complete randomization, stratification, and pair-matching in group- or cluster-randomized experiments.

Small-Sample Robust Variance Correction for Generalized Estimating Equations for Use in Cluster Randomized Clinical Trials
A working document from the Biostatistics and Study Design Core, this document examines available approaches to estimate variance, especially in the situation of a small number of clusters.

Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts
A checklist from the Biostatistics and Study Design Core about modifications to the statistical analysis plan that address disruptions in study conduct.

The Intraclass Correlation Coefficient (ICC)
A document explaining how the selection of a particular intraclass correlation coefficient (ICC) estimated during the planning stage of the study should be tailored to the study design and planned analysis.

Unequal Cluster Sizes in Cluster-Randomized Clinical Trials
A working document from the Biostatistics and Study Design Core about how cluster-randomized designs allow researchers to avoid contamination across intervention groups.

Assessing Fitness-for-Use of Clinical Data for PCTs
A handout describing data quality checks and recommendations for assessments.

ePCT Quick Start Guide for Researcher and Healthcare Systems Leader Partnerships
A handout designed to help clinical investigators successfully partner with healthcare system leaders.

Key Issues in Extracting Usable Data From Electronic Health Records for Pragmatic Clinical Trials
A working document from the Biostatistics and Study Design Core about missing data and other issues with electronic health record (EHR) and claims data in pragmatic clinical trials.

Patient-Centered Outcomes Toolkit
A toolkit providing resources to support the capture of patient-reported outcome (PRO) measures in diverse study populations. The toolkit is intended for research teams conducting pragmatic clinical trials.

Dimensions Influencing End-of-Trial Decision-Making and Related Questions to Consider
A resource looking across the dimensions of a trial and providing questions for investigators to consider during the end-of-trial decision-making process.

Dissemination Opportunities for Pragmatic Trials
A handout offering examples of strategies beyond academic publications to help investigators plan for broad dissemination.

Onboarding Data and Resource Sharing Informational Document 
A document providing background and information to assist clinical investigators in developing data sharing plans. To be used along with the Data Sharing and Resource Sharing Questionnaire.

Program for Readability in Science & Medicine: The PRISM Readability Toolkit
A compendium of strategies, real-world examples, and related resources to help researchers and others in the healthcare setting create materials that potential study participants can easily understand.

Reporting Pragmatic Clinical Trials
A template intended to help authors with the transparent reporting of their PCT.

NIH Collaboratory Trials Publication Types Handout
A reference intended to help the NIH Collaboratory Trial teams understand potential opportunities for publication.

Engagement in Research for Pragmatic Clinical Trials
A document providing considerations for investigators designing and conducting PCTs as well as for institutional review boards (IRBs) overseeing them.

NIH Collaboratory Trial Ethics/Regulatory Discussions: Minutes and Supplementary Materials
A document capturing discussions on ethical and regulatory issues relevant to each of the NIH Collaboratory pragmatic trials.

Tools for Data and Safety Monitoring
A collection of tools for data and safety monitoring in PCTs, including a data monitoring committee charter template and a "Points to Consider" handout.