Ask the IRB Experts What are IRB submission requirements for post marketing safety reports? Read More about What are IRB submission requirements for post marketing safety reports?
Ask the IRB Experts May I pay a physician for referring a patient to our study? Read More about May I pay a physician for referring a patient to our study?
Ask the IRB Experts What is the IRB’s role in making the nonsignificant risk device determination? Read More about What is the IRB’s role in making the nonsignificant risk device determination?
Ask the IRB Experts Submitting protocol changes to the IRB prior to submitting to FDA Read More about Submitting protocol changes to the IRB prior to submitting to FDA
Ask the IRB Experts Is IRB review required to collect specimens for a new test to diagnose COVID-19? Read More about Is IRB review required to collect specimens for a new test to diagnose COVID-19?
Ask the IRB Experts Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB Read More about Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB
Ask the IRB Experts What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research? Read More about What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?
Ask the IRB Experts What are the regulations for training home health individuals who are working remotely to collect study data? Read More about What are the regulations for training home health individuals who are working remotely to collect study data?
Ask the IRB Experts Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment? Read More about Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?
Ask the IRB Experts How Should I Handle Changes to Research Made in Response to COVID-19? Read More about How Should I Handle Changes to Research Made in Response to COVID-19?