Use font sizes ranging from 9 to 12 point. Times New Roman 12-point font is recommended for narrative text. When choosing a point size for tables, a balance should be made between providing sufficient information on a single page that may facilitate data comparisons while still achieving a point size that remains legible. Generally, point sizes 9-10 are recommended for tables; smaller point sizes should be avoided. Ten point fonts are recommended for footnotes. Black is the recommended font color except that blue can be used for hypertext links. Light colors do not print well on grayscale printers. Any colors used should be tested prior to submission by printing sample pages from the document using a grayscale printer. PAGE ORIENTATION
Save the page orientation for proper viewing and printing within the document. Proper page orientation eliminates the need for reviewers to rotate pages. For example, setting page orientation of landscape pages to landscape prior to saving the PDF document in final form ensures a correct page presentation. PAGE SIZE AND MARGINS
Set up the print area for pages to fit on a sheet of paper that is 8.5 inches by 11 inches. A margin of at least 3/4 of an inch on the left side of page avoids
obscuring information when pages are subsequently printed and bound. Setting the margin for at least 3/8 of an inch on the other sides is sufficient. For pages in landscape orientation, a margin of 3/4 of an inch at the top allows more
information to be displayed legibly on the page. Header and footer information should not invade the specified margins (i.e., header and footer information should not appear within 3/8 of an inch of the edge of the 8.5 by 11 inch page), so the text will not be lost upon printing or being bound. These margins allow printing on A4 as well. Oversized documents (e.g., CAD drawings or other specialized documents) and promotional materials submitted in PDF format should be created according to their actual page size.
SOURCE OF ELECTRONIC DOCUMENTS
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 reviewer 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, verify that imaged text is converted completely and accurately.
METHODS FOR CREATING PDF DOCUMENTS AND IMAGES
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, minimizes the file size. The use of grayscale and color significantly increases the file size and should be used only when these features improve the reviewability of the material. After scanning, avoid resampling to a lower resolution. A captured image should not be subjected to non-uniform scaling (i.e., sizing). See the following table for resolutions for various images.
修定日期：2014年10月21日
Table 2: Scanning Resolution Document type Handwritten notes Plotter output graphics Photographs - black and white Photographs - color Gels and karyotypes High pressure liquid chromatography IMAGE COMPRESSION TO REDUCE FILE SIZE Resolution 300 dpi (black ink) 300 dpi 600 dpi (8 bit gray scale) 600 dpi (24 bit RGB) 600 dpi (8 bit grayscale depth) 300 dpi Compress files using either Zip/Flate or CCITT Group 4. File compression is a method for reducing file size. Some methods of compression can result in loss of data and can introduce compression artifacts that affect the reviewability of the information. The following two methods provide lossless compression.
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Zip/Flate (one technique with two names) for lossless compression of color and grayscale images is specified in Internet RFC 1950 and RFC 1951. using the color profile provided by CMYK ensure color consistency for printing. The International Color Consortium (ICC)2 color profile specification is used when PDF documents are printed.
USE OF THUMBNAILS
PDF documents do not need embedded thumbnails.
HYPERTEXT LINKING AND BOOKMARKS IN TEXT AND TABLE OF CONTENTS
Hypertext links and bookmarks improve navigation through PDF documents. Use hypertext links throughout the body of the document to link to supporting
annotations, related sections, references, appendices, tables, or figures that are not located on the same page as the narrative text. Hypertext links in text can be designated by rectangles using thin lines or by blue text. A consistent method of designating links in a document avoids confusion. Using relative paths when creating hypertext links minimizes the loss of hyperlink functionality when submissions are loaded onto network servers. Both absolute links that reference specific drives and links to root directories do not work once the submission is loaded.
The document table of contents helps the reviewer navigate to the information of interest within the document that is not provided in the submission table of contents. For documents with a table of contents, provide bookmarks and hypertext links for each item listed in the table of contents including all tables, figures, publications, other references, and appendices that are essential for navigation through
documents. The use of invisible rectangles and blue text in the table of contents for hypertext links avoids obscuring text. Other help for navigation includes a bookmark hierarchy identical to the table of contents; up to 4 levels deep in the hierarchy.
When creating bookmarks and hyperlinks, set the magnification setting to “Inherit Zoom” so the destination page displays at the same magnification level that the reviewer is using for the rest of the document. INITIAL VIEW SETTINGS 2
http://www.color.org/
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Set the Navigation Tab to open to “Bookmarks Panel and Page.” This sets the initial document view when the file is opened. If there are no bookmarks, set the
Navigation Tab to “Page Only.” Page Layout and Magnification should be set to “Default.”
PAGE NUMBERING
In general, it is easier to navigate through an electronic document if the page
numbers for the document and the PDF file are the same, with the initial page of the document numbered as page one. There is an exception when a document is split because of its size (e.g., > 100 MB) and the second or subsequent file is numbered consecutively to that of the first or preceding file.
NAMING PDF FILES
Use lower case characters and avoid using special characters except hyphens and underscores in file names. Special characters to avoid include punctuation, spaces, or other non-alphanumeric symbols (e.g., \\ / : 3 ? <
> | “ % # +). The current FDA validation criteria and the ICH eCTD specification both provide additional guidance on allowable special characters in file names. SPECIAL CONSIDERATIONS FOR PROMOTIONAL MATERIAL
Promotional materials submitted in PDF format may need special consideration to ensure accurate representation of the actual image. Since color varies from monitor to monitor, it is difficult to ensure that the reviewer will see exactly the same color as in the actual image. Provide images at the highest resolution and depth practical. For photographs, the image should be obtained with a resolution of at least 600 dpi. Documents that are available only in paper should be scanned at resolutions that will ensure the pages are legible both on the computer monitor and when printed; at least 600 dpi is recommended. Promotional material should be submitted according to its actual size when practical. When an image size is altered, the original
dimensions must be stated. Images of three-dimensional promotional pieces must show all sides and components.
3 CCITT Group 4 Fax compression technique recommendations for lossless
compression of black and white images is specified in T.6 (1988) - Facsimile coding schemes and coding control functions for Group 4 facsimile apparatus. OPTIMIZE FOR FAST WEB VIEW
Create files from source documents using the “Optimize the PDF for fast web view” option to reduce file sizes and file opening times. IMAGE COLOR MATCHING
Because color varies from monitor to monitor, it is difficult to ensure that the reviewer will see exactly the same color as in the actual image. However, for printing, there is more control over the color by using CMYK (Cyan, Magenta, Yellow, Black) color model as opposed to the RGB model. Pantone Matching
修定日期：2014年10月21日