Page Orientation 2.5
Pages should be properly oriented so that all portrait pages are presented in portrait and
all landscape pages are presented in landscape. To achieve this, the page orientation of
landscape pages should be set to landscape prior to saving the PDF document in final form.
Page Size and Margins 2.6
The print area for pages should fit on both a sheet of A4 (210 x 297 mm) and Letter (8.5” x 11”)
paper. A sufficient margin of at least 2.5 cm on the binding edge (i.e., the left side of each page
for portrait and top of the page for landscape) should be provided to avoid obscuring information
when documents are printed and bound. The remaining margins should be a minimum of 1.0 cm.
Header and footer information and page numbers should not appear in margins.
Headers and Footers 2.7
The M4 Granularity document specifies that all pages of a document should include a
unique header or footer that briefly identifies its subject matter. With the eCTD, there is a
significant amount of metadata available to the reviewer to allow easy identification of the
document but it is still appropriate to have a unique identifier on each page (header or
footer) of the document (e.g., when the document is printed or multiple documents are
viewed on screen at the same time). The unique identifier does not necessarily have to
contain the CTD section identifier or other metadata. It should be sufficient to identify the
general subject matter of the document (e.g., study identifier, batch number).
Source of Electronic Document 2.8
You should avoid image-based PDF files whenever possible. PDF documents produced by
scanning paper documents usually have poorer image resolution than PDF documents
produced from electronic source documents such as word processing files. Scanned
documents are generally more difficult to read and do not allow the viewer to search or copy
and paste text for editing in other documents. If scanned files must be submitted, they should
be made text searchable where possible. If optical character recognition software is used, you
should verify that imaged text is converted completely and accurately.
Recommendations for Creating PDF Documents and Images 2.9
You should use the dpi settings in Table 2 for scanning documents. Scanned documents scanned
at a resolution of 300 dots per inch (dpi) ensure that the pages of the document are legible both
on the computer screen and when printed and, at the same time, minimises the file size. After
scanning, you should avoid resampling to a lower resolution. A captured image should not be
subjected to non-uniform scaling (i.e., sizing). See the Table 2 for resolutions recommended for
various image types.
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