Can DITA support the documentation of clinical trial design, patient recruitment criteria, and statistical analysis plans?

November 10, 2023
|By Bryan Tipper

DITA XML is a versatile framework that can effectively support the documentation of various aspects of clinical trials, including clinical trial design, patient recruitment criteria, and statistical analysis plans.

Structured Documentation

DITA allows for the creation of structured and modular documentation. Each element of a clinical trial, such as trial design, patient recruitment criteria, and statistical analysis plans, can be represented as separate DITA topics. This modular approach ensures that information is well-organized and can be easily updated or reused in different documents.

Version Control

Version control is crucial in clinical trial documentation to track changes and maintain a history of revisions. DITA provides versioning capabilities that enable users to monitor updates and contributions from different team members. This ensures that the documentation remains accurate and up-to-date throughout the trial process.

Example:

Here’s an example of how DITA can be used to document clinical trial design:


<topic id="clinical_trial_design" version="1.0">
  <title>Clinical Trial Design</title>
  <body>
    <p>...

  </body>
  <version-history>
    <version-info version="1.0" date="2023-11-15" contributor="Dr. Smith" />
    <version-info version="2.0" date="2024-02-20" contributor="Dr. Johnson" />
  </version-history>
</topic>

In this example, a DITA topic titled “Clinical Trial Design” contains structured content related to the trial’s design. It also includes versioning information, allowing for the tracking of changes and contributions by different team members.