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   If you do not, and outdated forms are submitted to OHRS, it is possible that the submission will not be processed or reviewed by the SRC and/or IRB.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 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 Outdated versions will not be accepted. 

• Protocol Front Sheet *REVISED*
  • Guidance on Completing Protocol Front Sheet *REVISED
• Alert Page Template
  • Guidance on Alert Pages *REVISED
• Amendment Form *REVISED
  • DFCI IRB Policy on Receipt and Review of IND/IDE Safety Reports
• PI/Site PI Change Form*REVISED
• Research Team Update Form*REVISED
• Request to Add/Remove a Site Form
  • Statement of Investigator Form
• Continuing Review Form *REVISED
  • Request to Continue Research Interventions 
• Serious Adverse Event (SAE) Reporting Form *REVISED*
  • DFCI IRB Adverse Event Reporting Policy
• Report of Unanticipated Problem Involving Risks to Subjects or Others
• Protocol Deviation Report Form*REVISED
• Protocol Deviation Log
  • Deviation/Violation/Exception Reporting Policy
• Closure/Re-Open to Accrual Form*REVISED
• Priority List Placement Change Form
• Request for the DFCI IRB to Cede IRB Review

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.