Last Updated: 03/27/15
Guidelines and Tools for
Protocol Development and Review
- Protocol Authoring Handbook
- Investigators’ Handbook
- Letter of Intent (LOI)
- Investigational Drug Steering Committee (IDSC)
- Recent Solicitations for letters of intent for investigational agents available through CTEP
- Concept Submission
- List of Codes and Values
- Protocol Templates and Applications
- Step by Step Guide for Submitting eSubmission Ready Documents to CTEP
- Cooperative Group Guidelines for Development, Conduct & Analysis of Clinical Trials with International Collaborating Institutions
About the Branch Chief
Michael Montello, PharmD, MBA, was appointed Branch Chief of CTOIB July 2015. Dr. Montello has been with CTEP for over 20 years. He has been a member of four different Branches and one Office within the Program. He is a retired Public Health Service (PHS) Officer. More…