Background
-Submitting clinical trial results to regulatory agencies is a crucial aspect of clinical development. The Electronic Common Technical Document (eCTD) has emerged as the global standard format for regulatory submissions. For instance, the United States Food and Drug Administration (US FDA) mandates the use of eCTD for new drug applications and biologics license applications.
+Submitting clinical trial results to regulatory agencies is a crucial aspect of clinical development. The Electronic Common Technical Document (eCTD) has emerged as the global standard format for regulatory submissions. For instance, the United States Food and Drug Administration (US FDA) mandates the use of eCTD for new drug applications and biologics license applications.
A CSR provides comprehensive information about the methods and results of an individual clinical study. To support the statistical analysis, numerous tables, listings, and figures are included within the main text and appendices. As part of the CDISC pilot project, an example CSR is also available for reference. If you seek additional examples of CSR, you can visit the clinical data website of the European Medicines Agency (EMA) clinical data website.
The creation of CSR is a collaborative effort that involves various professionals such as clinicians, medical writers, statisticians, statistical programmers. In this context, we will focus on the specific deliverables provided by statisticians and statistical programmers.
Within an organization, these professionals typically collaborate to define, develop, validate, and deliver the necessary tables, listings, and figures (TLFs) for a CSR. These TLFs serve to summarize the efficacy and/or safety of the pharmaceutical product under study. In the pharmaceutical industry, Microsoft Word is widely utilized for CSR preparation. As a result, the deliverables from statisticians and statistical programmers are commonly provided in formats such as .rtf, .doc, .docx to align with industry standards and requirements.
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