Module 2-3 – Operationalizing the Trial Design (17-min video)

• Designing a pragmatic clinical trial is only the beginning, the real challenge is making it work in messy, real-world healthcare. This video walks you through the practical side of trial execution, from turning a protocol into action to keeping teams, sites, and participants engaged.

** The video's content and narration were generated with the assistance of artificial intelligence, with human guidance and oversight throughout the process. **

Implementation Readiness Checklist (Website) 

• Checklist to identify milestones that mark trial readiness.

Source: DeBar L, Jarvik JG, Tuzzio L, Vazquez M. Assessing Feasibility: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory.

Randomization & Allocation Concealment Checklist (Download File)

• This checklist guides researchers through planning, generating, and implementing secure randomization and allocation concealment in clinical trials. It covers early design decisions, sequence generation with buffers, dry runs, finalization, and safeguarding allocation lists.

Template for Adherence Tracking Log (Download File)

• This adherence tracking log template is an example of how research teams can monitor how well trial sites follow study procedures. It includes example instructions, flagging rules, and a log to record site-level metrics, such as intervention delivery, medication adherence, visit completion, patient-reported outcomes, and data upload timeliness. Each metric is flagged green, yellow, or red based on performance thresholds, making it easy to spot issues early. 

Pragmatic Trials (PDF) 

• Pragmatic trials often include a wider range of patients, use routine care processes, and measure outcomes important to patients and health systems. They can better inform everyday clinical decisions, but face challenges like ensuring data quality and managing diverse settings. The authors highlight design principles, practical considerations, and the importance of balancing scientific rigor with real-world relevance.