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Clinical Research Support

Office for Human Research Studies (OHRS)

After Initial Submission Forms

AFTER INITIAL SUBMISSION FORMS

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   If you do not, and outdated forms are submitted to OHRS, it is possible that the submission will not be processed or reviewed by the SRC and/or IRB.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 Outdated versions will not be accepted.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

Continuing Review Submissions
CR submissions are due 60-90 days before expiration

  • Continuing Review for Interventional Research [Form]
  • Continuing Review for Non-Interventional Research [Form]    (Please do NOT use this form for interventional research. “Interventional research” refers to research that requires ANY interaction with participants (e.g., research involving the prospective collection of human tissue, research for which you are obtaining consent, etc.) 

  • Request to Continue Research Interventions [Form

Status Change Submissions

  • Closure/Re-Open to Accrual [Form]
  • Study Completion Request [Form]
  • Request to Remove Administrative Hold [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]
  • Individual Specific Research Team Update (*submit in Administration Update in OHRS Submit) [Form
  • Study Specific Research Team Update (*submit in Administration Update in OHRS Submit) [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.