UNC Lineberger Comprehensive Cancer Center Protocol Templates
Instructions/Tips for LCCC Investigator Initiated Chemotherapy Protocol Templates
The 4 linked templates on this page are primarily designed for studies focused on cancer treatment regimens, with chemotherapy as the main component of the regimen. The enclosed may be modified to address questions about radiotherapy or surgical oncology; separate templates for these areas are under development.
Choose your template depending 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.
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 (Most of 7.0 Adverse Events, and 9.0 Study Management, for example) 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.
Once you have completed your draft, select the Table of Contents (TOC), right click and then update your TOC.
If you find it easier to start a separate document and avoid the pre-formatted template, please follow the outline of the appropriate template and include all applicable boilerplate language.
If you have any questions about the templates, please contact Jeanne Noe at 843-7130, noej@med.unc.edu or Wasi Khan at 843-9499, wasi_khan@med.unc.edu.
