Compiling the Appendices for a Clinical Study Report
For any clinical regulatory writer compiling the appendices for a clinical study report (CSR) can feel like a daunting task, but it doesn’t have to be. To make this task easier and less time consuming you need to start thinking about it before you even begin to write the CSR. Below is a checklist that could help.
1. Using the International Conference on Harmonisation (ICH) guideline Efficacy 3 (E3) Structure and Content of Clinical Study Report write a list of everything you need for the final CSR. ICH E3 also contains guideline numbering.
2. Share your list with the Project Manager and ask them to provide the documents listed as they become final. Ask for Microsoft (MS) Word versions where possible and avoid scanned documents.
3. When possible review the Statistical Analysis Plan (SAP) and check that the tables, listings and figures are correctly numbered (see Step 1).
4. Open the CSR body in MS Word and change the font of all cross references, including sources for in-text tables and the table of contents (TOC), to blue and italicised text.
5. Within the CSR remove page numbers from the document footer.
6. In the TOC of the CSR, delete all page numbers that will change and replace with 'XXXXX' to act as a placeholder.
7. Before converting anything to a Portable Document Format (PDF) consider the US Food and Drug Administration (FDA) guidelines for submission ready files, this includes PDF specifications. e.g. you should use PDF V1.4, compatible with Acrobat 5.0 or higher. It also lists which fonts are acceptable e.g. Times New Roman is fine, Cambria is not.
8. For each appendix item create a cover page. The header should be identical to that in the CSR body. Remember even if the appendix is not applicable, create a cover page. You should also include blank/specimen signature pages, to be replaced later, if final versions are not yet available.
9. Combine cover pages and corresponding documents to create a PDF of each appendix item.
10. Convert the CSR body to a PDF file and combine all PDF files together.
11. Check the order of the files in the combined document is correct.
12. Ensure bookmarks are present throughout.
13. Insert hyperlinks so that all blue italicised text points to the correct place in the combined document.
14. Replace any blank signature pages with final pages.
15. Update the footer with page numbers, and add any extra header/footer information required.
16. Return to TOC and check whether any of the page numbers need to change from the original MS Word version and add any missing page numbers.
17. Finally, you should ask a colleague to perform a quality control check on the document.
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