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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.

clinical study report

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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i am looking for lists of documents needed to compile the appendices of CSR and for each document whom shall we contact to get those document. In other words, who is responsible to provide each document of Appendices.
Posted @ Tuesday, June 12, 2012 3:50 PM by Shweta
The process for collating the documents required for the CSR appendices will depend on the type of organisation the medical writer is working for. Pharmaceutical companies and CROs can have very different structures, and therefore company SOPs should always be consulted in the first instance. However, in general, the following guidance could be used: 
•The Project Manager should be asked to provide the protocol and amendments, IRC/IEB details, informed consent forms, investigator CVs, audit certificates, laboratory certificates and analytical reports. 
•The Project Statistician should be asked to provide the list of study drug batch numbers, randomisation scheme and codes, documentation of statistical methods, and any required statistical output. 
•The Sponsor should be asked to provide the report signatures (including Principal Investigator approval pages if agreed in the contract) and the details of publications based on the study and important publications referenced in the report. 
•The Data Manager should be asked to provide the sample case report form and case report forms for subjects with SAEs or AEs leading to withdrawal.
Posted @ Tuesday, June 19, 2012 9:49 AM by Thomas Underwood
when collecting references for your clinical study report. should you also collect references for sub-reports like Tox and BA reports that are usually part of the appendix section 16?
Posted @ Friday, August 10, 2012 10:07 AM by aca
It is usually not necessary to include references cited in additional reports that are contained in the appendix to a CSR. Each additional report within the CSR appendix should function as a stand-alone document and contain details of all references cited
Posted @ Thursday, August 23, 2012 4:26 AM by Thomas Underwood
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