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# ICH M14 Guide on Non-Interventional Study Principles Out
- URL: https://www.fdaweb.com/ich-m14-guide-on-non-interventional-study-principles-out/
- Published: 2026-03-03T12:00:00.000Z
- Updated: 2026-09-14T13:34:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160751

FDA has published the International Council for Harmonization’s M14 guidance, *General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies that Utilize Real-World Data for Safety Assessments of Medicines*. The [document](ttps://www.fda.gov/media/179795/download) covers general principles for planning, designing, analyzing, and reporting non-interventional studies that use fit-for-use (sometimes known as fit-for-purpose) data for a safety assessment of medicines.

The guide outlines recommendations and high-level best practices for conducting non-interventional pharmacoepidemiologic safety studies to streamline the development and regulatory assessment of study protocols and reports.

“These recommendations and practices also seek to minimize the conduct of multiple studies on the same safety concern for submission to multiple regulators, and to improve the ability of the study protocol to be accepted across regulatory authorities, and support decision-making in response to study results,” the document says.

The guidance contains an Introduction, General Principles, Conceptual Framework for Generating Adequate Evidence Using Real-World Data, Initial Design and Feasibility, Protocol Development, Data Management and Creation, Analysis, Reporting and Submission, Dissemination and Communication of Study Materials and Findings, Study Documentation and Record Retention, Considerations in Special Populations, Glossary, List of Abbreviations, and References.