The process of designing a detailed plan for a clinical research study, which has been reviewed and approved by an Institutional Review Board (IRB) to ensure ethical and scientific integrity.
This phrase signifies that the planned research adheres to ethical guidelines and regulations for protecting human subjects. IRB approval is mandatory for research involving human participants in most jurisdictions.
"Clinical research protocol development with institutional review board approval is underway for the phase 3 trial."
Used to document that the research plan has received the necessary ethical oversight.
Common questions about using medical phrases in clinical documentation