Unanticipated Problem and/or Serious or Continuing Noncompliance Application

The NCI CIRB has created an application for the submission of potential unanticipated problems and/or serious or continuing noncompliance for trial-wide review by the boards. 

A copy of the application is available on the CIRB website here. To submit and complete an application in IRBManager, email the board that reviewed the study and request that an application be assigned to the study team.

A summary of the SOP changes can be found here. 

The Quickguide with instructions called “Completing the Unanticipated Problem and/or Serious or Continuing Noncompliance Submission Application” is available on the CIRB website.  

Translation Application 

The NCI CIRB has created an application for the submission for trial-wide translations.  A copy of the application is available on the CIRB website here. To submit and complete an application in IRBManager, email CIRBConsentForms@emmes.com.  

A summary of the SOP changes can be found here.

The Quickguide with information about the types of translations and expectation for each translation can be found here. The Quickguide for completing the Translation Application can be found here.

If you have any questions, please contact the NCI CIRB Helpdesk or call 1-888-657-3711.