Compilation of Clinical Study Report Appendices

by | Jul 11, 2019 |

A clinical study report (CSR) is a pivotal document in the drug submission process, which is prepared for presenting methods and results of a clinical trial. The guidelines provided by International Conference on Harmonisation (ICH) are used to prepare a complete CSR. Before even writing a CSR, many writers find it difficult to compile the appendices (contain supplementary information) for submitting CSR to the regulatory bodies. These appendices, when requested by the regulatory authorities, need to be submitted within 48 hours.

Section 16 of a CSR comprises all the appendices. It includes general information about the study, case report forms (CRFs), and listings containing individual patient data. The individual PDF files are submitted for each Section 16 appendix (16.1, 16.2, and 16.3). The general flow for preparing the appendices is given below:

  • Before you can begin even to write a CSR, it is essential to know which appendices are to be added with it, for which, ICH E3 guideline helps a lot. It is better to have a list of every appendix file. The ICH E3(R1) guideline also helps to collect the publishing items easily, as it allows certain documents to be excluded from the CSR appendices if they are included in the Study Trial Master File (TMF) which can only be intimated by the sponsor.
  • It is better to use Microsoft (MS) Office Word versions or PDFs. There should be correct page orientation, no password protection, and text searchable wherever possible, except for the scanned files. The PDF files should not be larger than 100 MB.
  • Do not use scanned documents and MS Excel files unless there is no other option. If scanned files are to be used, they should be scanned using a scanner that provides clear scanned images.
  • After this, review the files properly along with checking all the numbered items, their versions, and validity.
  • Each appendix file should contain individual cover page depicting the title of that appendix followed by a table of contents created in MS Word. For appendices that are not applicable for CSR, a cover page should still be present, and ‘Not applicable’ should be added to it. For each update to the appendix, the table of contents needs to be revised.
  • All unnecessary blank pages should be deleted.
  • The bookmarks and hyperlinks should be present within each appendix file for the items listed in the table of contents. These bookmarks and hyperlinks should be correctly added to track their correct destination on a single click.
  • After each appendix file is reviewed, bookmarked and hyperlinked, add the header and footer to every page of it. The header and footer parts should be consistent with that used in the CSR. Each page of the appendix file should be paginated (i.e., pagination starting again within each file), generally through the footer.
  • After final PDFs have been made, ensure that any external and internal hyperlinks and bookmarks referenced in the table of contents or CSR body are correctly active in the form of PDFs (linked to correct destination).
  • Finally, a quality control check should be performed on the entire document by another person.

The CSR appendices should not be crowded with unnecessary documents. E.g., if documents used by non-English-speaking patients or doctors have been translated from English to different languages, then, only the English version of the documents need to be included in the appendices.

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