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 Is IRB review required when linking to clinicaltrials.gov postings on patient advocacy websites and newsletters? Read More about Is IRB review required when linking to clinicaltrials.gov postings on patient advocacy websites and newsletters?
Ask the Experts Is parental consent required for research involving children? Read More about Is parental consent required for research involving children?
Ask the Experts Do parents need to accompany adolescents at each research-related office visit? Read More about Do parents need to accompany adolescents at each research-related office visit?
Ask the Experts As a sponsor, does my HGT clinical trial require IBC approval at all sites? Read More about As a sponsor, does my HGT clinical trial require IBC approval at all sites?