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E-submission Format for Sub-chronic and Chronic Studies

Current as of June 25, 2008

The purpose of this document is to suggest the format for final reports (right column) and to provide instructions for creation of Adobe PDF electronic submission documents (left column). Regarding PDF, both 'bookmarks' and 'links' are referenced. Bookmarks and links are similar in function in that both provide the reader with a way to move efficiently through a document as well as across documents. Bookmarks are a type of link that appear in the navigation pane on the left side of the PDF Reader user screen. Links appear within the body of a document as blue text. They permit the reader to jump to other locations with related information in the same document or other electronic documents.

Instructions to Create PDF Full Submission Format
Create Bookmarks for each item in the
Document Format column.
  • Study Title Page
  • Statement of Data Confidentiality
  • GLP Statement
  • Flagging Statement if appropriate
  • Table of Contents
Create links in summary to related text and tables
in body of study report or appendices.
Executive Summary
  • Summary of Materials and Methods
  • Summary of Results
  • Maternal Toxicity (when applicable)
  • Offspring Toxicity (when applicable)
Create links to related text in results section and
tables for each end point.
Materials and Methods
  • Materials
  • Procedure and Study Design
  • Observations
  • Data Analysis and Statistics
Create links to related subject heading, text,
tables, appendices, or supplemental files.
  • Results and Discussion
  • Tables (see example list below)
  • Appendices
  • Figures
  • Supplemental Files

Example Tables for Developmental Neurotoxicity Studies

Maternal Data Tables:

  • Clinical Observations
  • Functional Observation Battery
  • Body Weights
  • Food Consumption
  • Litter data (size, mean weight, survival, etc.)

Offspring Data Tables:

  • Clinical Observations Functional Observation Battery
  • Body Weight, Body Weight Gain
  • Developmental Landmarks
  • Auditory Startle Test
  • Motor Activity
  • Learning and Memory
  • Time and Cause of Death (if applicable)

Offspring Post Mortem Examination Tables:

  • Gross Pathology
  • Brain Weights
  • Brain Dimensions
  • Microscopic Pathology
  • Morphometric Findings