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Congruency Review: The Game Changer
Manage episode 398035284 series 3506216
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Insider Exposes crucial missing step in Clinical Trial Agreements activation - Congruency Review Details Revealed!
In the clinical trial agreement activation pathway, the journey involves several critical steps. It begins with the signing of the Confidentiality Disclosure Agreement (CDA), followed by the study team's review of the protocol and feasibility goals. Once the study gets the green light, the congruency review phase becomes crucial. This phase kicks off with a Medicare coverage analysis to determine what falls under research billing and sponsor billing versus insurance billing.
The Medicare coverage analysis further involves creating a detailed calendar and schedule of events in the clinical trial management system. Budget negotiations come into play, and once finalized, the financial console aligns with the clinical trial management system calendar. Simultaneously, contract and informed consent negotiations occur, often involving multiple groups within the institution and various vendors.
Despite the complexity, there's a notable gap in the industry – the lack of comprehensive congruency review. This gap is observed both on the site side and the pharmaceutical side. Many times, discrepancies arise when regulatory discussions conflict with legal interpretations, and there's no final congruency review to ensure alignment between the Medicare coverage analysis, calendar, budget, contract, and informed consent form. Bridging this gap becomes pivotal to ensure a seamless and error-free process.
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