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
Videos Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans Read More about Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans
Blog Posts Assessing Potential Risks in the Consideration of IND Exemption Criteria Read More about Assessing Potential Risks in the Consideration of IND Exemption Criteria
Blog Posts Defining “Minimal Risk” in Clinical Research Read More about Defining “Minimal Risk” in Clinical Research
Ask the Experts Which comes first – IRB or IBC approval? Read More about Which comes first – IRB or IBC approval?
Ask the Experts Approval of an Investigational New Drug Study Read More about Approval of an Investigational New Drug Study
Whitepapers Drafting a Research Plan for IRB Review and Research Conduct: Information that Must Be Included in a Clinical Trial Protocol Read More about Drafting a Research Plan for IRB Review and Research Conduct: Information that Must Be Included in a Clinical Trial Protocol
Ask the Experts What are the requirements for notifications of study closure at research sites? Read More about What are the requirements for notifications of study closure at research sites?