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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
Pediatric Biomedical Protocol Template
Radiation Protocol Template
Instructions for Submitting Protocol Documents to CTEP [Guidance]
Guidelines for Writing a Minimal Risk Research Protocol
Guidelines for Writing a Social/Behavioral Science Research Protocol
Guidance on Writing a Research Protocol
Supervisory Plan for Clinical and Non-Clinical Research
Guidance on Developing a Supervisory Plan for Clinical and Non-Clinical Research

IND Development    

Original IND Application Template
Original IND Submission Transmittal Letter

Study Drug Diary

Drug Diary Template - Multiple Drugs
Drug Diary Template - One Drug

Multi-Center Trials

Guidance for Submitting a DF/HCC PI-Initiated Multi-Center Trial [inclusion of sites external to DF/HCC and DF/PCC]

Inclusion of Minorities

Monitoring Clinical Trial Accrual by Gender, Race, and Ethnicity: Cancer incidence data by diagnosis or by geographic region
Sample Minority Recruitment and Outreach Plan

Recruitment, Retention, Intervention, and Education Materials & Support

Evidence-based Health Communication Consultation, Strategy, and Materials

Clinical Trial Registration

Guidance for ClinicalTrials.gov Registration and Management

Contact Information

Clinical Trials Education Office (CTEO)
Health Communication Core
Office for Human Research Studies (OHRS)
Quality Assurance Office for Clinical Trials (QACT)

See Also

OHRS Forms and Instructions