Study Maintenance

Amendment Protocol deviations/violations
Request protocol exception Serious Adverse Events (SAEs)
Change in principal investigator/study staff Re-opening a closed study

**Effective immediately: SAEs and deviations must be reported by completing and submitting the REPORTABLE EVENTS FORM (Please see: IRB POLICIES Section).**

 

Amendment

If the changes do not fall within the minimal risk criteria, the amendment needs to go to full committee.

 

Protocol Deviations/Violations

Please refer to the Institutional Review Board's Reportable Events Policy and Form to report Deviations, Violations and Serious Adverse Events.

 

Request protocol exception

Researchers may request an exception to an approved protocol if it is known that a deviation will likely occur in a planned situation. These are not permanent changes to the protocol.

Examples: 

  • If a potential study subject meets all eligibility requirements except one, a researcher may request an exception to allow that subject into the study. 
  • If an enrolled subject will be out of town at the time of protocol-directed tests or treatments, an exception request may be filed to allow this one time variation from protocol, allow the event to occur either before or after the planned date. 

Exceptions should be submitted in letter format explaining the requested exception and why it is necessary. The letters should be submitted via IRBnet and will be reviewed by the IRB chair.

 

Change in principal investigator/study staff

Re-opening a closed study

  • If the study is expedited or just being re-opened to data analysis only, then a letter explaining why the study should be re-opened needs to be submitted along with any revised documents.
  • If the study is full committee and being re-opened to enrollment, a letter of explanation and the entire protocol needs to go back to full committee for review.
  • If you are resubmitting due to the continuing review not being submitted, then a Continuing Review Form also needs to be completed.
  • If the study originally was in paper format, you must submit it via IRBNet along with a new Registration Page (using the IRBNet Wizard). We then pull the old file from the warehouse and scan in any old documents.