ISIWriter FAQs

 
Why are the templates installed on the network not accessible to the users?
Modify the path of the Workgroup Template location, pointing to the network folder by choosing Tools >> Options >> File Locations >> Workgroup Templates in MS Word.

Is there way I can populate repeated information in my document?
The Document Information button enables the population of repeating information into fields which eliminates the redundancy of populating the same information through out the document.

Is there an easy way I can format a table that is pasted from a different source?
The Repair Table button adjusts the size and positioning of tables that do not fit within the margins when a table is pasted from another source, have been changed from landscape to portrait, or the user manually changed the table size or adds columns.

What is difference between Paste as Plain Text and Paste Safely?
The “Paste as Plain Text” feature strips all attributes from the pasted text so that only the content of the text is inserted. The “Paste Safely” option pastes text or graphics, mapping most styles, table formatting, graphics, and other attributes, to ISIWriter styles without changing the formatting of the document.

Is there a quick reference guide for Pharmacokinetic and Mathematical Symbols?
he Symbol and Pharmacokinetic (PK) toolbars allow you to quickly and easily enter pharmacokinetic, mathematical, and legal symbols into a Word document. Each symbol button displays a Screen Tip of its use when the mouse cursor is placed over it. The Show Symbol Toolbar button and Show PK Toolbar button shows and hides the toolbar accordingly.

The new Granularity Annex document from FDA says that numbering of sections within documents does not have to include the document's numbering. Will ISIWriter be incorporating this change?
Excerpt: "Section Numbering Within Documents In order to avoid 5th, 6th, etc., level subheading numbering (e.g., 2.6.6.3.2.1) within the applicant can use a shortened numbering string. In this case, the document name (e.g., 2.6.6 Toxicology Written Summary) should appear in page headers then section numbering within the document can be used, for example, 1, 1.1, of the full numbering string (e.g., 2.6.6.3.2.1) is also considered acceptable."

The Granularity Annex gives you an 'out' so that you don't have to 'use up' heading levels 1-5 just to start your document with heading 2.6.6.3.2.1. ISIWriter uses a 'prefix' so that you're still using Heading 1, with "2.6.6.3.2." attached to each number as a fixed string of characters, avoiding the problems. We have not yet decided whether to make changes to the templates based on the new guidance. In the meantime, the templates can be easily modified at your site to use the simpler numbering scheme:

  1. In version 1.0, go to Tools > Document Options. In 1.1 go to Tools > ISIWriter Options
  2. Clear out the "Prefix" and "Starting Number" fields. In 1.1 uncheck the checkbox at the bottom that saves all shaded settings as defaults
  3. In version 1.0, click on OK then go to Tools > Make Document Into Template. In 1.1 just click on the "Templates" tab at the top of the dialog
  4. Select the "Content Template" option and click OK.
  5. Save the template.
Why aren't there any templates for CTD sections 1.3 through 1.10?
These documents are mostly federal forms which can be found at the FDA website.