Please download the Modification Study Designs Sheet from the link provided below. The document is separated into sections. Within each section, please review the modification level and study design. If you agree with the proposed recommendations for each study, no comments are needed. If you have a comment(s) please indicate the study and provide your comment in the boxes, (Technical and/or Editorial), provided within in each section. Please provide justification for any recommended changes.
The Modificatoin Detail Sheet document and the Modification Guideline policy document are provided as supporting materials for the review and can be downloaded from the links below.