The templates do not only provide guidance for the content, but also contain examples of commonly-used wording and suggested paragraphs throughout the entire document.
Instructions are in red font, and explain what the regulatory authorities expect to be written in each section according to the ICH guidelines. After following the instructions, this red text should be deleted.
Placeholders are in green font, and mark study-specific details that need to be entered. Once those details have been entered, the font color should be changed to black.
Example text is in blue font, and offers suggestions for phrasing a section. After modifying the text, the font color should be changed to black.
Standard verbiage is in black font, and is usually widely-applicable and not study-specific, but should still be checked for accuracy, and modified where appropriate.
