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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.
Before even writing a CSR, many writers find it difficult to compile the appendices (contain supplementary information) for submitting CSR to the regulatory bodies.
Section 16 of a CSR comprises all the appendices.
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.
If scanned files are to be used, they should be scanned using a scanner that provides clear scanned images.