ACUTA Regulatory Intelligent Documents
ACUTA Regulatory Intelligent Documents (ARID) is a set of over 250 shell documents defined by regulatory agencies and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), covering the marketing and clinical trial application processes for Europe, the United States, and Canada.
Accompanying them is an add-in for Microsoft Office Word which combines the most-used features of Word’s ribbon toolbar onto a single tab along with focused tools for managing regulatory documents and bullet-proofs the creation of common headers and footers.
A compact, focused version of the Microsoft Office Word toolbars, and a menu driven system to select from agency-specified shell documents for submissions give ARID users a quick start on regulatory authoring.
Document Selection and Configuration
ARID’s function to create a New Document guides you through selection of the right shell document for the work you need to do, drilling down through the specific region and module to the particular document type for the task. Before the document can be created, the specific metadata for that document is entered – previous values may be selected from drop-down lists.
The New Document function also permits you to select a Profile for the document. Profiles let your company customize the margins and select what text and metadata appear in the headers and footers.
The ACUTA Tab on the Microsoft Office ribbon provides a combination of the most commonly-used features of Word – including those from the Insert and References tabs – with features customized for creation of regulatory documents, including:
Numbered and Unnumbered heading styles (Unnumbered styles are used for items such as the Synopsis and Table of Contents), and multi-level lists for quick document outlining.
Tools for creating Tables, and Captions and Source References for Tables and Figures. Styles for the table heading, body, and notes are easily accessible.
Easy control of paper size (letter and A4) and layout (portrait or landscape), demystifying Word’s “Section Breaks”. Page Breaks are controlled neatly using the “Page Break Before” capability.
More than 100 symbols grouped into categories of Greek Letters, Mathematical Symbols & other commonly used characters.