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