Welcome to eLearning Center, an online resource library that references key talks, policies, and general information that affects investigators and research staff across Dana-Farber/Harvard Cancer Center. These educational materials are available to help you with your day-to-day clinical research responsibilities.

These short voice-over Powerpoint presentations are a quick and easy way to review basic information and expectations about DF/HCC research processes and compliance.

• DF/HCC Standard Operating Procedures for Clinical Research (SOPs)

A selection of DF/HCC Clinical Investigator Education Series and/or Research Education Series Powerpoint presentations from the last three years. 

Cancer Care and Research at DF/HCC in 2015  (Presented by Barrett Rollins, MD, PhD)
Investigator-Held IND Studies (Presented by Jeffrey Clark, MD)
Investigator-Initiated Multi-Center Trials (Presented by Jeffrey Clark, MD)
Response Assessment Criteria for Clinical Trials (Presented by Cheryl Sadow, MD)
Some Considerations for Choosing Among Types of Phase I Designs (Presented by Paul Catalano, ScD)

A variety of easy to use tools to assist with study management, regulatory and DF/HCC requirements.  Each template can be downloaded and customized to meet the specific needs of your study.

Templates for Investigator-Held INDs
Initial IND Submission to FDA
     1. Original IND Submission Transmittal Letter
     2. Original IND Application Template
IND Amendment
     1. IND Amendment Transmittal Letter
IND Safety Reporting
     1. IND Safety Report Transmittal Letter
     2. SAE (Dear Doctor) Transmittal Letter
IND Annual Report for FDA
     1. IND Annual Report Transmittal Letter
     2. IND Annual Progress Report
IND Withdrawal
     1. IND Withdrawal Transmittal Letter

Templates for Investigator-Written Trials
BioMedical Protocol Template
Drug Diary Template-Multiple Drugs
Drug Diary Template-Single Drug

Multi-Center Trials Templates
1. Multi-Center Trials (Procedure and DSMP Template)
2. Site Initiation Checklist
3. Communication Log
4. Lead Site AE Tracking
5. Lead Site SAE Tracking
6. Participating Site AE Tracking
7. Participating Site SAE Tracking
8. Source Documentation Verification

A collection of practical reference sheets bringing the concepts of good clinical practice to life.

Tip Sheets

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  • Office for Human Research Studies (OHRS)
  • Quality Assurance Office for Clinical Trials (QACT)
  • Clinical Investigations Leadership Committee (CLC)
  • Clinical Trials Education Office (CTEO)
    • Education
    • Services
    • Contacts
  • Clinical Research Unit (CRU)
  • Protocol Review and Monitoring System (PRMS)
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