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Clinical Research Support

Office for Human Research Studies (OHRS)

Submitting A New Protocol

FORMS FOR NEW PROTOCOL SUBMISSION

For information relating to protocol development or submission, please:

  1. Review the guidance on the OHRS website; or,

  2. Contact one of the offices below:

    a. Questions from DFCI & BWH staff contact the DFCI CTO,  617.582.9040 or email dfci_clinicaltrials@dfci.harvard.edu

    b. Questions from MGH staff contact the MGH CCPO, 617.724.0695 or email your CCPO contact.

    c. Questions from BIDMC staff contact the BIDMC CCTO, Jonathan Dinsmore at 617.632.9473 or email bidmccctoregulatoryaffairs@bidmc.harvard.edu

    d. Questions from BCH staff(Children’s users) contact Jane O’Brien at 617.632.3549  or email jane_obrien@dfci.harvard.edu

 Quick Help Guides for New Protocol Submissions:

Specific requirements for:

  • PI-Initiated Multi-Center Trials [Guidance]
  • Single Patient INDs & Emergency Use of a Test Article [Guidance]

New Project Application Forms & Guidance

Statement of Investigators

Other Submission Forms

  • Endorsement [Form] | [Guidance]
  • Program Leader List for Endorsement Forms [List]
  • Protocol Front Sheet [Template] | [Guidance
  • Study Specific Research Team Update [Form]  
  • Alert Page [Template] | [Guidance
  • Research Funding Form [Form]
  • Pregnant Partner Investigator Signature Form [Form]
  • Department of Defense Supplement Form [Form] [11.20.14]