- Choose your template depending on your study design, on whether your study includes a Phase I component, and whether it is a UNC Chapel Hill only (single center) or multi-center trial.
- The template documents open as word files; save as a word file once you start drafting your protocol. When opened as a word file, all the pages listed on the Table of Contents (TOC) revert to page 1. Place your cursor on the TOC, right click, and then click on “update field”. Update “entire table”, and the correct page numbers should appear.
- Please do not clear the formatting on your template.
- The Table of Contents (TOC) is hyperlinked. After selecting the TOC, if you hold the cursor just in front of a page number on the TOC and hit the control key and then left click on your mouse, your cursor will jump to that section in the document.
- All instructions in the template are highlighted in yellow. Please review these instructions and address as applicable for your protocol.
- If you select all instructions for a particular section and start typing, this should delete the instructions, and remove the highlighting. If it does not, select the text you want to remove highlighting from, click the arrow next to Highlight on the Formatting toolbar, and then click "None."
- Those sections not highlighted include standard boilerplate language that should remain in your draft.
- If a particular section is not relevant for your study, just remove it-your document should automatically re-number for you. Similarly, if additional sections are needed to clarify your study, insert as appropriate.
- Once you have completed your draft, select the Table of Contents (TOC), right click and then update your TOC.
- If you have any questions about the templates, please contact Jeanne Noe at 843-7130, firstname.lastname@example.org
I. Single Center Chemotherapy Phase I, Phase I/II, Phase II
II. Multi-Center Chemotherapy Phase I, Phase I/II, Phase II
III. Health Services Research Template
IV. Multi-Center Radiation Therapy Phase II
V. Correlative Sciences Template