Regulatory Writing Terms
Essential vocabulary for understanding AI-assisted documentation
Clinical Study Report (CSR)
A comprehensive document that describes the methodology and results of a clinical trial, following ICH E3 guidelines. CSRs are primary regulatory submissions required by health authorities.
Periodic Safety Update Report (PSUR)
A regulatory document summarizing the benefit-risk profile of a marketed drug or device over a defined reporting period. PSURs are required by regulatory agencies to monitor post-approval safety.
Chemistry, Manufacturing, and Controls (CMC)
The section of a regulatory submission (eCTD Module 3) covering drug substance, drug product, manufacturing process, and quality controls. CMC documentation ensures the drug can be manufactured consistently.
Provenance
In regulatory writing, the documented origin and traceability of every piece of content to its source document, section, table, or image. Provenance supports audit readiness and regulatory compliance.
Tables, Figures, and Listings (TFL)
Statistical outputs from clinical trials that summarize efficacy and safety data in tabular and graphical formats. TFLs are primary sources for narrative interpretation in Clinical Study Reports.
Statistical Analysis Plan (SAP)
A detailed document that outlines the statistical methods and analyses to be performed on clinical trial data. SAPs are written before trial data analysis to prevent bias.
Core Data Sheet (CDS)
A document containing safety and efficacy information for a drug, used as a reference for product labeling globally. The CDS is a foundational document for PSURs and other safety reporting.
eCTD (Electronic Common Technical Document)
The standardized format for regulatory submissions to health authorities worldwide. The eCTD structure ensures submissions are organized consistently across jurisdictions.
ICH E3
The International Council for Harmonisation guideline defining the structure and content of Clinical Study Reports. ICH E3 is the gold standard for CSR formatting and content requirements.
ICH E2C(R2)
The ICH guideline for Periodic Benefit-Risk Evaluation Reports (PBRERs), also known as PSURs. This guideline specifies the format and content requirements for periodic safety reporting.
Hallucination (in AI)
When an AI system generates content that is not grounded in the provided source material. Asthra prevents this through closed-system architecture and granular context engineering, ensuring outputs use only your documents.
Context Engineering
The systematic approach to providing AI models with precisely the right source material needed to generate accurate, grounded outputs for each document section. Context engineering is key to preventing hallucinations.
TransCelerate
An industry collaboration that develops standardized CSR templates to improve consistency and efficiency in clinical trial reporting. TransCelerate templates are widely used by pharmaceutical companies.
Terms are organized alphabetically. Use your browser's find function (Ctrl+F or Cmd+F) to search for specific terms.
Learn More
For deeper dives into how Asthra applies these concepts in practice, check out our resources and guides on provenance, context engineering, and hallucination prevention in regulated documentation.
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