Who's REALLY Responsible for a Clinical Trial Congruency review?

In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical companies and research sites share the responsibility for ensuring congruency between the budget, contract, informed consent form (ICF), and coverage analysis. Istvan mentions that a lack of congruency affects both parties and, therefore, both sides should actively participate in the vetting process. While pharmaceutical companies are responsible for ensuring budget and contract congruency, research sites should also conduct thorough reviews to align coverage analysis, budget, and contract. In Istvan’s view, it's not an either-or scenario; both sides play a crucial role in maintaining congruency throughout the clinical trial process. #clinicaltrialcongruency #researchintegrity #researchcompliance #researchsites #congruencyreview#clinicaltrialmanagement #clinicaltrialbestpractices #clinicaltrialmishaps #pharmaceuticals #collaborativeresponsibility #congruencychallenges #darshantalks #dt #kulkarnilawfirm #klf #recentrecap Website: http://www.darshantalks.com Law Firm: http://www.kulkarnilawfirm.com Twitter: https://twitter.com/darshantalks LinkedIn: https://www.linkedin.com/in/darshankulkarni/ Sign up for my newsletter: https://darshantalks.com/ ---- Disclaimers: This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship