Clinical Investigator Toolkit
The goal of the Clinical Investigator Toolkit is to provide standardized tools to assist DF/HCC clinical investigators in writing and developing clinical research trials that are in compliance with regulatory and other requirements. The use of these tools is highly recommended for all investigator-initiated research studies.
Protocol Development
Biomedical Protocol Template
Guidelines for Writing a Minimal Risk Research Protocol
Guidelines for Writing a Social/Behavioral Science Research Protocol
Tips for Writing a Research Protocol
IND Development
Original IND Application Template
Original IND Submission Transmittal Letter
Study Drug Diary
Drug Diary Template - Multiple Drugs
Drug Diary Template - One Drug
Tips for Creating a Study Drug Diary
Multi-Center Trials
DF/HCC Multi-Center DSMP Template [for inclusion of sites external to DF/HCC]
Instructions for Modifying the Multi-Center DSMP Template