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LEARN MORE ABOUT REMOTE SERVICES

Keep Your Clinical Trial Moving from a Distance

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.

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Posted by Paul Cobb on Mon, Nov 06, 2017

5 Tips for Keeping Great Principal Investigators

Dr. Robert Findling, Director of Johns Hopkins Division of Child and Adolescent Psychiatry and leading researcher in pediatric psychopharmacology, views being a principal investigator as “a privilege, not a right.” Dr. Findling has been noted as saying “with privilege comes great responsibility”. Principal investigators who subscribe to this philosophy can set themselves apart by leading the development of cutting-edge technology and novel treatments. According to 21 CFR 812.100, General Responsibilities of investigators, P.I.s are responsible for conducting research according to the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth by the IRB.

Topics: 21 CFR 812; Principal Investigator, Principal Investigators

Posted by John Lehmann on Fri, Jun 03, 2016

“21 CFR 812 & A Principal Investigator’s Oversight”

According to the regulations for clinical trials, the PI is personally responsible for conducting and supervising the conduct of human subjects research by “protecting the rights, safety, and welfare of subject’s under the investigator’s care”.  The PI also has to ensure that all the research he is responsible for is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB. So what exactly is “oversight”?  Oversight is defined in the Webster’s online dictionary as “management by overseeing the performance or operation of a person or group; watchful care, superintendence, general supervision”. As you can imagine, this can be quite an undertaking.

Topics: Oversight, 21 CFR 812; Principal Investigator, Clinical Research