You are responsible for using the most current version of our IRB forms posted on this website.   If you do not, and outdated forms are submitted to OHRS, it is possible that the submission will not be processed or reviewed by the SRC and/or IRB.  Please make sure to ALWAYS download forms directly from this website.  Forms downloaded to your computer will not be the most recent version and will delay review.  Opening forms directly from the OHRS website before filling them out and submitting them to us will assure you have the most up-to-date form and will save both you and the OHRS time. 

A revised front sheet MUST be submitted with the following revisions: Amendment, PI/Site PI Change, Research Team Update, Request to Add New Site IF the revision changes the information captured on the front sheet (ie. protocol name, protocol version date, type of trial, principal investigator, site principal investigator, collaborating investigators, study contacts, participating sites, and subject population). All revised front sheets must be on the most current template. Outdated versions will not be accepted. 

Click here for Frequently Asked Questions

Amendment Submissions

• Alert Page  [Template] | [Guidance]
• Amendment  [Form] | [DFCI IRB Policy on Receipt & Review of IND/IDE Safety Reports]
• PI/Site PI Change [Form] | [Change of PI for Leave of Absence]
• Protocol Front Sheet [Template] | [Guidance]
• Report of Change in Outside Interest [Form] | [Log Sheet]
• Request to Add/Remove a Site [Form] | [Checklist]
  • Statement of Principal Investigator [Word Form] | [PDF Form] | [PDF Form Guidance]
  • Outside Interests [Log Sheet]
  • Conflict of Interest [Policy]
• Research Team Update [Form] 
  • 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]
  • Conflict of Interest [Policy]

Continuing Review Submissions

• Continuing Review for Interventional Research [Form]
• Continuing Review for Non-Interventional Research [Form]
• Request to Continue Research Interventions [Form] 

Status Change Submissions

• Closure/Re-Open to Accrual [Form]
• Study Completion Request [Form]

Other Event Submissions

• Adverse Event (AE) Reporting [Form] | [Policy]
• Deviation/Violation  [Policy]
• Minor Deviation/Violation [Log]
• Major Protocol Deviation/Violation Report [Form]
• Report of Unanticipated Problem Involving Risks to Subjects or Others [Form]

Other Submissions

• Administrative Update [Form]
• Priority List Placement Change [Form] | [Guidance]
• Document Request [Form] 

Link to QACT Forms, which include:
Forms for registering or removing a subject to/from a protocol,
escalating to the next dose cohort,
requesting data from your PI-initiated protocol,
providing information to the DSMC or DSMB, and
looking up toxicity codes.