Listen to this episode Just a podcast and video to answer a few viewer emails over this past week in regards to Principal Investigator oversight and FDA guidance on this, How to find a new PI for a new research clinic, and IRB audits.~ read more ~
Posts tagged IRB
Meetings Have Meaning! Stacey Carmody, CCRP Coordinators travel to their fair share of meetings, most of them being investigator meetings. It is at these meetings we learn about a new protocol and take an opportunity to connect with others in the field. We meet other coordinators, monitors and investigators, often swapping stories about past and […]~ read more ~
Submit Protocol Deviations and Continuing Review Reports To IRB’s In A Timely Manner For Your Clinical Trials!
In yet another example of “do as I say not as I do”, in this video I give a viewer some advice for how to deal with your IRB, specifically your central IRB for your particular clinical trials. While an IRB audit is no where near as serious as an FDA or Sponsor audit, it […]~ read more ~
Today’s video comes as a response to a viewer who has worked for an ethics committee/IRB in the past and noticed a potential business opportunity in this space. She is planning on setting up a consulting company which basically will process the IRB submissions on behalf of the research clinics out there. My suggestions to […]~ read more ~
Throughout the years that I have been blogging on this website, I usually create content to help study coordinators or other clinical research professionals understand how protocols should be followed. What is rarely talked about when it comes to clinical research educational content is what happens when a protocol is actually not followed the way […]~ read more ~
Here is the question I received (edited to keep anonymous) regarding hospitals and clinical trials: I got a job at a CRO that currently does phase 2 through phase 4 research. They hired me to do research into phase 1, to see how possible it is to expand their operations to phase 1 research. The […]~ read more ~