Whitepapers What Can Institutions with Local IRBs Do to Prepare for a Proposed FDA Single IRB Mandate? Read More about What Can Institutions with Local IRBs Do to Prepare for a Proposed FDA Single IRB Mandate?
Whitepapers Reviewing the FDA’s Proposed Single IRB Mandate Read More about Reviewing the FDA’s Proposed Single IRB Mandate
Whitepapers Reviewing the FDA’s Proposed Informed Consent Rule Changes Read More about Reviewing the FDA’s Proposed Informed Consent Rule Changes
Ask the Experts Should a Protocol Amendment be submitted in advance of Consent Form changes? Read More about Should a Protocol Amendment be submitted in advance of Consent Form changes?
Ask the Experts Should Parents Be Allowed to View their Child’s Survey Responses? Read More about Should Parents Be Allowed to View their Child’s Survey Responses?
Ask the Experts Do all subjects need to be reconsented with the revised consent form? Read More about Do all subjects need to be reconsented with the revised consent form?
Whitepapers The Basics of the Individual Expanded Access Request Process: A Resource for Physicians Read More about The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
Ask the Experts Is informed consent needed for post-market patient registry? Read More about Is informed consent needed for post-market patient registry?
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 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?