Ask the Experts
Ask The Experts Insights
Viewing all entries for: Ask the Experts
Ask the Experts
Ask the Experts
What are the IRB review requirements for human factors/usability testing?
Read More about What are the IRB review requirements for human factors/usability testing?
Ask the Experts
Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Read More about Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Ask the Experts
What questions can be asked when screening patients prior to them signing consent?
Read More about What questions can be asked when screening patients prior to them signing consent?
Ask the Experts
When do I report a protocol deviation to the IRB? Do I need to report a summary of deviations at the time of continuing review?
Read More about When do I report a protocol deviation to the IRB? Do I need to report a summary of deviations at the time of continuing review?
Ask the Experts
What documentation needs to be submitted to the IRB for an IND exemption request?
Read More about What documentation needs to be submitted to the IRB for an IND exemption request?
Ask the Experts
Can you provide an IRB approval before FDA’s review of the IND?
Read More about Can you provide an IRB approval before FDA’s review of the IND?
Ask the Experts
Does research involving retrospective review of patient charts require IRB review?
Read More about Does research involving retrospective review of patient charts require IRB review?
Ask the Experts
How do EUAs for COVID-19 vaccines affect IBC oversight requirements for ongoing clinical trials?
Read More about How do EUAs for COVID-19 vaccines affect IBC oversight requirements for ongoing clinical trials?
Ask the Experts