I cannot find what the risk/benefit is for my protocol. What should I put in this box?
Look at the original minutes from the initial review of the protocol. The risk/benefit as determined by the IRB should be documented there. Please be sure that if your protocol includes more than one population of subjects (e.g. donors and recipients, children and adults, normal volunteers, etc.) that you note the risk/benefit determination for each group.
I updated my précis in the study application but the old précis still appears in my continuing review submission form. Why doesn’t it pull forward?
The précis is not a pre- defined field in iRIS. The précis is pulled and saved in Continuing Review form (table) once from the initial Study application form. Every time you create Continuing Review form, the same précis (initial) will appear even if you change it in the study application. Therefore, you have to re-enter (copy and paste) the new précis into the continuing review form if there is a change.
There is a question that asks: “have any UPs, deviations and or non-compliance occurred since the IR or last CR?” How do I answer this if I had no events in the last reporting period?
If you have not had any UPs, deviations or non-compliance occur in the past year or time period since the last IRB review, the answer to this question is "no". Only answer "yes" to this question if events have occurred in the time period since the last IRB review of the study.
The next instruction asks you to summarize UPs, reportable adverse events, deviations, and non-compliance as defined in the protocol since the last CR and in aggregate since the start of the study. You should prepare a table of all the reportable AEs (which would include the UPs that are also AEs) that have occurred since the last CR and in total since the start of the study. You should also create a table listing of all of the deviations and non-compliance that has occurred since the start of the study. These tables should be put together in a single pdf document before you upload it into iRIS.
FAQs for Routing in iRIS
FAQs for Study Application
FAQs for Amendment Submission Form
FAQs for Planned and Cumulative Enrollment Forms
FAQs for Study Closure Form
These pages will continue to be updated as more information becomes available.
Note: If you have a submission procedure question that isn’t answered within these pages, please contact: firstname.lastname@example.org