To comply with the 21st Century Cures Act, 1 the Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs). NPRMs are the initial public notice of a proposed change to ...
CARY, N.C., Sept. 15, 2025 /PRNewswire/ -- WCG, a global leader in providing solutions that measurably improve and accelerate clinical research, today announced the launch of WCG ClinSphere™ eReview ...
The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process for referring research involving children ...
Due to the involved nature of the IRB review process, submitting research projects for review can prove to be challenging. In order to simplify the process and support investigators, the IRB has ...
This policy describes the requirements and procedures for: Ceding review of human research studies conducted by UNR faculty, staff or students to external IRBs; Accepting UNR IRB review of human ...
Adults are not always capable of representing children’s views and interests, and many ethical issues in paediatric research ...
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