Shri Arun Madhavan's talk at Purna Pragnya. He speaks of what the children of Purna Pragnya must feel when they leave after finishing their studies. He gives a glimpse of the fundamentally simple meaning of our life.
BE guidelines recommend investigator should possess appropriate medical qualification, experience for conducting pharmacokinetic studies Can chairperson of EC directly write to sponsor to clarify some of the queries of clinical trial raised in EC meeting? Dr. Sreevatsa Please see an extract from FDA's comment on IRB-sponsor relationship. The interrelationship and interaction between the research sponsor (e.g., drug, biologic and device manufacturers), the clinical investigator and the Institutional Review Board (IRB) may be very complex. The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study. The clinical investigator generally provides the communication link between the IRB and the sponsor. Such linkage is agreed to by the sponsors and investigators when they sign forms FDA-1571 and FDA-1572, respectively, for drug and biologic studies or a...
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