Consent misconception: 'No signature required = no consent needed' Reality: 👍🏻 Waiver of Written Consent still demands full informed consent 👩🏽💻💬 Documentation can be digital/verbal 🤔 Participant understanding remains mandatory 📋 Process > Paperwork Are you confusing compliance with participant protection? Niecy Duncan, CCRC, PMP® breaks it down for you > https://lnkd.in/ejCc6yKP #ClinicalTrials #InformedConsent"
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The classification is based on harm severity, not probability, making them safety classes. Understanding these classes can help you navigate regulatory compliance with confidence. 💡 Need expert guidance? Book a call at https://lnkd.in/di9PK3iC #DigitalHealth #MedicalDevice #SoftwareSafety
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Informed Consents - Let's Complete Them Correctly? Check out the team's newest Spotlight article to learn what informed consent is, why it is important, and what information should be included to ensure they are completed correctly. Read more at https://lnkd.in/ePHEYVZE. Follow Courtemanche & Associates for the most up-to-date accreditation and regulatory compliance information & trends.
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🌟 Webinar Highlights: What You Missed 🌟 Our recent AMA Webinar was packed with valuable insights from our Protocol Experts! Here's a quick recap: ▪️ In-depth Protocol Insights: We dove deep into the intricacies of Medical, Fire, and Police Protocols, shedding light on best practices and common pitfalls. ▪️ ProQA Configuration Tips: Our experts shared tips on how to fine-tune ProQA to better fit your agency’s needs, ensuring smoother operations and more accurate dispatching. ▪️ Interactive Q&A: Attendees got their toughest questions answered live, with our team providing actionable advice that can be implemented right away. Missed it? Don’t worry—we’ll be sharing more insights soon. Or check out the recording here! https://bit.ly/3zu7nuh #EmergencyDispatch #911Dispatch #WebinarRecap #ProQA #PublicSafety #ProtocolExperts #ContinuousImprovement
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Navigating the intricate regulatory landscape to obtain approval for submitting regulatory documents can be a daunting task. It requires a meticulous attention to detail, as the process involves adherence to a labyrinth of rules and guidelines. Here's a compass to guide you through the maze: #regulatorysubmissions #translationprecision #approvalreadiness
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Chief Information Officers (CIOs) that are procuring and implementing an electronic patient record (EPR) solution can find themselves in contractual agreements that don’t benefit their trusts in the long-term. This 7-step guide outlines the things to think about, plan for and navigate in order to avoid the pitfalls of contractual negotiations. Read it now at: https://buff.ly/4hVkqGr #EPR #DigitalHealthcare #DigitalTransformation
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Regulatory professionals are essential in navigating the complex regulatory landscape, ensuring that products are safe, effective, and compliant with all legal requirements. Their expertise and diligence help protect public health and foster innovation in the industry. #RegulatoryAffairs #Compliance #RegulatoryProfessionals #IndustryInsights #QualityAssurance #ProductSafety #RegulatoryStrategy
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Rules change fast, and missing a regulatory deadline can be costly. At DP Distribution & Consulting, we stay on top of the latest regulations so you don’t have to. Focus on what you do best—we’ll take care of the rest. Contact us today! Visit our website for more information: www.dpdconline.com #RegulatoryCompliance #MedicalDevices #MedicalConsulting #DeviceRegulation #HealthcareCompliance #FDARegulations #HealthcareConsulting #QualityManagement #RiskManagement #DPDConsulting #medicaldeviceregulation #medicaldeviceFDA
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Healthcare research strategist | Trainer | Innovations enthusiast | General Manager at Metrics Research (Pvt) Ltd.
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