All submitted documents must be SINGLE SIDED.

Please click here to view specific requirements for: PI-Initiated Multi-Center Trials

Please click here to view specific requirements for: Single Patient INDs & Emergency Use of a Test Article

Affiliate and Network Sites click here to access the Clinical Trial Request Form:
https://dfpccaffiliates.dfci.harvard.edu/network&calgb/documents/ctrf.pdf

Click on documents to view:

• Protocol Front Sheet
• Guidance on Completing Protocol Front Sheet 
• Endorsement Form 
  • Guidance on Completing Endorsement Forms 
  • Program Leader List for Endorsement Forms 
• Review Process for New Adult Clinical Trials
  
  
• New Project Application Forms:
  
  • Clinical Trials 
    
    • Radiation Safety Protocol Screening Form
  • Social/Behavioral Research  
    
    • Helpful Resource: Guidelines For Writing A Social/Behavioral Science Research Protocol
  • Medical Record Review  
    
    • Helpful Resource: Guidelines for Writing a Specimen/Data Collection and Banking Research Protocol
  • Research Use of Human Material/Tissue  
  • Request for Exemption or Determination that Activity is Not Human Subject Research  
    
    • Helpful Resource:  OHRS Information Sheet: Determining if Project is Human Subject Research
• Statement of Principal Investigator Form for New Applications 
• Co-Investigator Form for New Applications 
• Alert Page Template
  • Guidance on Alert Pages 
• Request for the DFCI IRB to Cede IRB Review