Common technical documents (CTDs) are the application dossiers required for the registration of new medicines in Europe, the USA and Japan, and are the end-product of the clinical development process; they are the ultimate challenge in writing clinical documentation.
The CTD dossier is divided into five main modules:
Module 1: Administrative information and prescribing information
Module 2: Overviews and Summaries of Modules 3–5
Module 2.1 Table of contents
Module 2.2 Introduction
Module 2.3 Quality Overall Summary
Module 2.4 Non-clinical Overview
Module 2.5 Clinical Overview
Module 2.6 Non-clinical Written and Tabulated Summaries
Module 2.7 Clinical Summary.
Module 3: Quality (pharmaceutical documentation)
Module 3.1 Table of contents of Module 3
Module 3.2 Body of data
Module 3.2.S Drug Substance
Module 3.2.P+ Drug Product
Module 3.3 Literature references used in Module 3
Module 4: Non-clinical reports (pharmacology/toxicology)
Module 4.1 Table of contents of Module 4
Module 4.2 Study reports
Module 4.2.1 Pharmacology
Module 4.2.2 Pharmacokinetics
Module 4.2.3 Toxicology
Module 4.3 Literature references used in Module 4.
Module 5: Clinical study reports (clinical trials).
Module 5.1 Table of contents of Module 5
Module 5.2 Tabular listing of all clinical studies
Module 5.3 Clinical study reports
Module 5.3.1 Reports of biopharmaceutic studies
Module 5.3.2 Reports of studies pertinent to pharmacokinetics using human biomaterials
Module 5.3.3 Reports of human pharmacokinetic (PK) studies
Module 5.3.4 Reports of human pharmacodynamic (PD) studies
Module 5.3.5 Reports of efficacy and safety studies
Module 5.3.6 Reports of post-marketing experience
Module 5.3.7 Case report forms and individual patient listings
Module 5.4 Literature references.
As for all documents, the display of information in the CTDs should be unambiguous and transparent. The format and content of CTDs is set out in ICH M4. In particular, the CTDs Summary (Module 2, sections 2.5 and 2.7) presents a medical writer with the significant task of summarising all elements of a clinical development programme, sufficient for the reviewer to quickly establish the most critical conclusions of the cumulative dataset.
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- MedTrans has extensive experience in preparing hundreds of CTDs submissions, from straightforward local variations to complex global submission dossiers for multiple indications.
- Clients all over the world appreciate our proactive involvement in ensuring that all aspects of the clinical development programme are appropriately synthesized in a reviewer-friendly manner.
- MedTrans meets deadlines – a vital factor in successful and timely drug approvals.
- MedTrans can provide eCTD-compliant dossiers in collaboration with a strategic partner.
Contact us today to find out how our CTDs writing expertise can help you.
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