Clinical Research Support
Office for Human Research Studies (OHRS)
Submitting A New Protocol
FORMS FOR NEW PROTOCOL SUBMISSION
Click here for Quick Reference for New Protocol Submissions
Click here for Frequently Asked Questions
Specific requirements for:
- PI-Initiated Multi-Center Trials [Guidance]
- Single Patient INDs & Emergency Use of a Test Article [Guidance]
New Project Application Forms & Guidance
- Clinical Trials [Form]
- Social/Behavioral Research [Form] | [Guidelines For Writing This Protocol Type]
- Research Use of Retrospective Medical Records and/or Previously Collected Specimens [Form] | [Guidelines for Writing This Protocol Type]
- Research Use of Human Material/Tissue [Form]
- Request for Exemption or Determination that Activity is Not Human Subject Research [Form] | [Guidance]
- Request for DFCI IRB to Cede IRB Review [Form]
- Quality Improvement Determination [Form]
- Statistical Guidelines for Non-Clinical Research Protocols [Guidance]
Statement of Investigators
- Statement of Principal Investigator [Word Form] | [PDF Form] | [PDF Form Guidance]
- Statement of Co-Investigator [Word Form] | [PDF Form] | [PDF Form Guidance]
- Outside Interests Log Sheet [Form]
- Conflict of Interest [Policy]
Other Submission Forms
- Office for Human Research Studies (OHRS)
- Contacts
- Information for Sponsors
- Submitting A New Protocol
- Single Patient IND/Emergency Use of a Test Article
- Consent Documents
- After Initial Submission Forms
- HIPAA
- Information Sheets
- Resources for Biospecimen and Biobanking Research
- ANPRM
- FDA Guidance
- External Regulatory Guidance
- OHRS News Updates
- Oncology Protocol System and OHRS Submit
- Presentation and Training Materials
- Partners Policy and Guidance Links
- Office for Human Research Studies (OHRS)
- Quality Assurance Office for Clinical Trials (QACT)
- Clinical Trials Education Office (CTEO)
- Clinical Investigations Leadership Committee (CLC)
- Clinical Research Unit (CRU)
- Protocol Review and Monitoring System (PRMS)
- OnCore
