Your #IRB questions. Our expert answers. ❓As decentralized clinical trials (DCTs) become more common, what are the IRB’s requirements for submitting research locations? 💡Our expert, Erin Bower, shares the answer in our #AskTheExperts blog. Read now at https://lnkd.in/gFQE3ntb #DCTs #decentralizedtrials #clinicaltrial #clinicalresearch #WCG #ethicalreview
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All TMF University courses are accredited by IAOCR - International Accrediting Organization for Clinical Research the world's only organization that qualifies clinical research professionals to international standards. Check out this video by Ben Rogers on why TMF University is right for you or your organization. Register for Cohort 3 here: https://bit.ly/36kw3Xs * * * #TrialMasterFile #eTMF #IAOCR #GCP #ClinicalResearch
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In the August 2023 Clinical Researcher, Susan Landis shares how the burden of the adoption of DCTs falls to the sites, which means that we have to listen to site leaders and their study teams about their experiences in order to get it right. She shares how ACRP has striven to stay on top of the evolving situation through blog insights, white papers, comments to the FDA, and an introductory course on DCTS. Up next... a new white paper on “Overcoming Obstacles to Decentralized Clinical Trials: Unique Perspectives from Research Sites and Clinical Research Professionals.” Catch up on what we've done and get a sneak peek in what's to come > https://bit.ly/45JAapg #DecentralizedClinicalTrials #DCTs #ClinicalResearcher #ACRP #FDAGuidance #Blogs #TrainingCourses
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🎓 Just completed the NIDA Clinical Trial Network course on Good Clinical Practice! 🌟 Excited to enhance my understanding of ethical research practices and contribute to the advancement of clinical trials. #ClinicalResearch #GCP #ContinuousLearning
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As summer fades, the spotlight turns to the Trial Master File (TMF) in clinical research. It's our shield for trial integrity and participant safety. Streamlined regulations, clear documentation, and foresight in archiving set the stage for successful studies. In the complex world of the Trial Master File, steadfast adherence to clinical compliance remains a cornerstone of success." Learn more about LMK here: https://bit.ly/44ZVl68 * * * #TrialMasterFile #ClinicalResearch #ClinicalTrials #LifeSciences
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Webinar (9/13): 'Investigator-initiated Trial Tips and Tricks' The concept of the “site as sponsor” is becoming more common for #clinicalresearch conducted at #academic institutions. This #webinar will highlight best practices in various areas of clinical research #management of investigator-initiated trials (IITs) and detail how to navigate common challenges. With intellectual ownership of study implementation, there are numerous tasks to consider: #budget and invoicing, specimen collection, processing, and transport, #data collection, #IRB and consent documents, staff #training, study #monitoring, #regulatory responsibilities, publication authorship agreements, and data use and management. Areas overlooked within the planning phase in IITs can hinder swift execution of study deliverables and scientific progress. Included in this offering are effective, simple checklists and best practices for study start up and tracking study progress. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with The National Institutes of Health Regulations. Learn more and register: https://lnkd.in/gsqnGvpE via ACRP - Association of Clinical Research Professionals
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While many of the refinements in decentralized clinical trials (DCT) are still being cemented, we’ve put together some best practices on how best to deal with them in the meantime. Read our blog on it to learn more. https://lnkd.in/ghbYvqMM #clinicaltrials #IRB #DCT
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Pursuing Protocol Designs That Maximize The Value Of Decentralized Clinical Trials https://buff.ly/3OrUx4c #clinicaltrials #decentralizedclinicaltrials #DCTs
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Webinar: How to Make Efficient FDA-Compliant Clinical Protocol Amendments Date: March 8, 2024 | Time: 12 PM EST Trainer: Dr. Mukesh Kumar, PhD, RAC, CEO, FDAMap Learn more: https://lnkd.in/eyihnYV #fda #clinicalprotocol #clinicaltrials #clinicalresearch #clinicalstudies #clinicaldevelopment #fdaregulations #fdacompliance
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Successfully completed the NIDA Clinical Trials Network's Good Clinical Practice course! 🌐👩🔬 Deepened my understanding in areas like Institutional Review Boards, Informed Consent, and more. As I continue my journey pursuing an MSc in Clinical Research, this certification adds a solid foundation to my commitment to ethical and quality research practices. 📚🔍 #ClinicalResearch #GCP #ProfessionalDevelopment #ResearchEthics
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"Empowering Health through Research: Msc in Clinical Research Student at Padmashree Institute of Clinical Research Bangalore”
Completing the Good Clinical Practice course by NIDA Clinical Trials Network was worth it because it provided detailed information on various crucial aspects such as Institutional Review Board, informed consent, confidentiality, adverse events, Quality assurance, Protocol and roles/responsibilities of investigators and sponsors. The course also covered recruitment and retention strategies. By studying this information thoroughly, I was able to successfully complete quizzes for each topic. Overall, the course was valuable and helped me gain important knowledge in the field of clinical research. #clinicalresearch #clinicaltrials #GCP #qualityassurance #nidaclinicaltrailsnetwork
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