limitations and are requested to keep filenames and pathnames in submissions as short as possible. The IMDRF folder templates and file naming specifications have been established in an effort to ensure submissions can be received and stored by regulators without reaching the operating system limits. It is recommended that applicants examine the length of the entire pathname (i.e. all nested folders and file name and file extension) prior to transmission to verify the path length is 200 characters or less. File and Submission Size Limitations No individual PDF file in the submission shall exceed 100 MB. The entire submission should not exceed 4GB to ensure acceptance by all participating regions. Document Security Files should not have any security settings, specifically: Files must not have password protection preventing the file from opening. Files should be set to allow printing, selecting text and graphics, and adding or changing notes and form fields. Applicants should use secure upload facilities or reputable couriers to protect the transmission to the regulators. Bookmarking in PDF Files It is also important that PDF files be properly structured, with a properly bookmarked internal table of contents. The following are recommended as good structuring practices: Documents of ten pages or more should have their own internal table of contents. When creating bookmarks, the magnification setting should be set to Inherit Zoom so that the destination page displays at the same magnification level that the reviewer is using for the rest of the document. Sections, subsections, tables, figures and appendices should all be bookmarked. Attachments to PDF files should be avoided. Too many levels of bookmarks are inefficient. In most instances, three levels of bookmarks should be sufficient: 1 Heading 1.1 Subheading 1.1.1 Sub-subheading. It is recognized that bookmarks are generated automatically from document headings; nevertheless, it is recommended that they be kept concise.
limitations and are requested to keep filenames and pathnames in submissions as short as possible. The IMDRF folder templates and file naming specifications have been established in an effort to ensure submissions can be received and stored by regulators without reaching the operating system limits. It is recommended that applicants examine the length of the entire pathname (i.e. all nested folders and file name and file extension) prior to transmission to verify the path length is 200 characters or less. File and Submission Size Limitations No individual PDF file in the submission shall exceed 100 MB. The entire submission should not exceed 4GB to ensure acceptance by all participating regions. Document Security Files should not have any security settings, specifically: Files must not have password protection preventing the file from opening. Files should be set to allow printing, selecting text and graphics, and adding or changing notes and form fields. Applicants should use secure upload facilities or reputable couriers to protect the transmission to the regulators. Bookmarking in PDF Files It is also important that PDF files be properly structured, with a properly bookmarked internal table of contents. The following are recommended as good structuring practices: Documents of ten pages or more should have their own internal table of contents. When creating bookmarks, the magnification setting should be set to Inherit Zoom so that the destination page displays at the same magnification level that the reviewer is using for the rest of the document. Sections, subsections, tables, figures and appendices should all be bookmarked. Attachments to PDF files should be avoided. Too many levels of bookmarks are inefficient. In most instances, three levels of bookmarks should be sufficient: 1 Heading 1.1 Subheading 1.1.1 Sub-subheading. It is recognized that bookmarks are generated automatically from document headings; nevertheless, it is recommended that they be kept concise.
imdrf-wi-toc-pilot-guide-n27r2.docx