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Clinical Research Support


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

Contact Information

Biostatistics
CTEO
OHRS
QACT

See Also

OHRS Forms and Instructions