10  Overview

In a late-stage clinical trial, the number of A&R deliverables can easily be in the hundreds. For an organization, it is common to have multiple ongoing clinical trials in a clinical program.

To deliver the A&R results of a clinical trial project, it is teamwork that typically requires collaborations from both statisticians and programmers. In this part, let’s consider how to organize a clinical trial project as an A&R lead.

Chapter 11 will discuss how to organize source code, documents, and deliverables in an A&R clinical project. We recommend using the R package folder structure.

Chapter 12 will discuss a process or system development lifecycle to manage the A&R of a clinical project. We recommend following an agile management approach to define, develop, validate, and deliver work.