Research Compliance

Latest Discussion Posts

  • ​Would any of you be willing to share your process on how you determine high- risk clinical trials for audit, including the criteria used to score these. Thank you. Gabriella ------------------------------ Gabriella Neff BS,CHC,CHRC,CHPC Research Compliance ...

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    Privacy Board SOP

    ​We are attempting to establish a Privacy Board at my institution.  This group will not be affiliated with our IRBs and will be reviewing requests for waivers of authorization and altered authorizations.  If any of you have such a board, would you be ...

  • I used to be the research regulatory affairs manager at our site, and I can attest that we did do this process with one CRO and sponsor. It is ok to do, by regulation, but if/when you do find a patient that fits the criteria and your site plans to open ...

  • I've not heard of this approach.    It sounds like a pragmatic way to do research, but I would be very cautious about the regulatory requirements from FDA, OHRP and HIPAA as applicable. ------------------------------ Lynn Shields CHC,CHPC Director of ...

  • I may need a different perspective here. I've been approached by an investigator who is working with a CRO and has been asked to identify research participants (review inclusion/exclusion criteria) prior to the IRB approving our site. In other words, ...

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