How does DITA compliance align with medical documentation standards (e.g., ICH E3)?

November 10, 2023
|By Bryan Tipper

DITA compliance aligns with medical documentation standards, including those like ICH E3, in several key ways. ICH E3, or the International Council for Harmonisation’s guideline for structure and content of clinical study reports, sets specific standards for documenting clinical trials and studies. DITA’s modular content architecture and extensible framework provide an ideal foundation for aligning with ICH E3 and similar standards in the medical field.

1. Structured Content:

ICH E3 emphasizes structured and consistent documentation of clinical trials. DITA’s topic-based approach enforces a structured content model where information is organized into discrete topics. Each topic can represent a specific section or aspect of a clinical study report, ensuring that data is organized in a standardized and consistent manner, which is in alignment with ICH E3 requirements.

2. Content Reuse:

ICH E3 requires cross-referencing and consistency between different sections of clinical study reports. DITA enables content reuse and cross-referencing through techniques like conref (content referencing). This ensures that critical information, such as study objectives or patient demographics, is consistent across different parts of the report. For example, you can use conref to refer to the same patient demographic data in the methods section as in the results section, maintaining consistency.

Example:

Here’s an example of how DITA XML can be used to ensure cross-referencing and consistency as per ICH E3 guidelines:

<!-- Example: DITA XML for Cross-Referencing -->
<topic id="study-objectives">
  <title>Study Objectives</title>
  <body>
    <p>The study aims to evaluate the effectiveness of the drug in patients with hypertension.</p>
  </body>
</topic>

<topic id="patient-demographics">
  <title>Patient Demographics</title>
  <body>
    <p>The study involved <data><element>500</element><element>patients</element></data> with hypertension.</p>
  </body>
</topic>

<topicref href="study-objectives.dita"/>
<topicref href="patient-demographics.dita"/>

By referencing the patient demographics topic in the study objectives section, DITA ensures consistency and alignment with ICH E3 and other documentation standards.