Clinical Data Interchange Standards Consortium (CDISC)
August 22, 2024
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Document-level publishing of a clinical study report (CSR) refers to one of the steps of preparing an integrated clinical study report for submission to the concerned regulatory authority. Further this includes the final clinical study report and all the associated documents. According to the ICH E3 guideline, the clinical and statistical descriptions are integrated into a single clinical study report. This ICH E3 guideline has been created by the authorities in such detail to reduce the post-submission requests for further data clarification and analyses.1
Regulatory authorities require the industry to prepare a drug dossier which should contain detailed information about the clinical and non-clinical aspects of the drug product. However, this dossier used to differ according to the regulations of the local regulatory authority. Therefore, to get a balanced system, the ICH developed a standard content format known as the Common Technical Document (CTD).
However, after the development of CTD and running it for many years, the CTD paper format created difficulties in the review process for regulatory authorities. Thus, in 2016, the US FDA (along with the other regulatory authorities) started accepting only electronic CTD (eCTD) submissions for all application types.2
The document-level and submission-level publishing of a CSR are mandatory parts of the eCTD submissions.3
As document-level publishing of a CSR is a crucial step for regulatory approval, it is important to take each step carefully. The process of document level publishing mainly involves compiling source documents, converting them to PDFs, hyperlinking, preparing the table of contents, paginating the documents, and specifying document details.
The first and foremost steps include the compilation of the CSR and source documents as per the ICH E3 guideline.1 To begin with comply with the ICH E3 guideline, place the content and documents in the given chronological order. Further, ensure the compiled source documents are accurate and error-free. Then, most importantly, convert the source documents to PDF format according to the standards set by the regulatory authorities.
Provide each source document with its own table of contents to accurately represent the content. Further, bookmark and hyperlink every source document or the CSR itself accurately, and check each hyperlink for functionality before finalizing the compiled file.
Additionally, perform a quality check according to the internal quality checklist set by the organization. Further, carefully check all points on the checklist across the integrated CSR, if there are any errors, the medical writer must resolve the issues and update the changes.
Document-level publishing of a CSR is a crucial step to getting the drug product data available to the regulatory reviewers. Also, the regulatory decision for the marketing approval of drug product depends on this step. Thus, it is important to give critical attention to each step of document-level publishing. Any mistake at this level can create issues at the submission-level publishing stage. Although validation tools are available that detect mistakes in linking documents; however, the placement of incorrect source documents in the integrated CSR cannot be tracked by the validation software. This requires giving keen attention to the integrated CSR at each step before moving to the next step and submitting it to the regulatory authorities.
1. International Conference on Harmonization. Structure and content of clinical study reports E3. database.ich.org. Published 30 November, 1995. Accessed 28 August, 2023. https://database.ich.org/sites/default/files/E3_Guideline.pdf
2. United States Food and Drug Administration. FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions. Published 22 September, 2016. Accessed 27 September, 2023. https://www.fda.gov/files/drugs/published/%22FDA-Requires-Use-of-eCTD-Format-and-Standardized-Study-Data-in-Future-Regulatory-Submissions%22-September-22–2016-Issue.pdf
3. United States Food and Drug Administration. Electronic Common Technical Document (eCTD). Published 22 March, 2023. Accessed 27 September, 2023. https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.