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But that little change implies study on Agenda I drugs needs a number of additional hoops that analysis on other medications don’t. Step one is usually to pen a protocol for just a analyze: a system for a way the researchers plan to carry out their investigation.
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This protocol is judged by an institutional evaluate board, an independent team that assessments any clinical trials involving humans. If a study entails a Timetable I drug, after the board approves the protocol as ethical, the scientists should apply for an investigational new drug (IND) number from the FDA.