Ask the Experts Is it appropriate to compensate participants for unscheduled trips to the site? Read More about Is it appropriate to compensate participants for unscheduled trips to the site?
Ask the Experts Should we exclude subjects who recently received COVID-19 vaccine from participating in other research studies? Read More about Should we exclude subjects who recently received COVID-19 vaccine from participating in other research studies?
Ask the 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 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 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 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 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 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 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 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?