‘Hot Topics’ and Practical Considerations forProtecting Human Research ParticipantsIN-PERSONMAY 8 & 9, 2025 | SAVANNAH, GAWorkshop registration fee: $590 (Non-member $665 - includes one year’s membership)Objective: This two-day conference for Clinical Research Professionals will study, explain, and discuss how ICHGCP and the Code of Federal regulations guide and direct investigator and sponsor responsibilities related to postapproval monitoring, modernizing consent, adherence to clinicaltrials.gov and the NIH Data Management and Sharingpolicy. The attendee will understand and be able to convey the responsibilities of these very important functions,the complementary role of the clinical researcher as a fundamental contributor to successful clinical research and theprotection of research subjects.The program will focus on the relationships among clinical trial staff, investigators, IRBs the FDA, CROs and sponsors.The conference will highlight areas that present challenges to sponsors and investigational sites: navigating single IRB,writing effective informed consent documents, improving the informed consent process, use of genomic data, futureuse of stored bio-specimens, and risk-based monitoring communication. Discussion surrounding research in the virtualworld since the recent pandemic and pain points that continue after the implementation of the Common Rule revisionswill be explored. Insights about establishing a robust educational program and accessing effectiveness of the programon an ongoing basis will also be examined.The program will identify best practices and strategies to provide potential solutions for these challenges. Insightsabout establishing a robust educational program and accessing effectiveness of the program on an ongoing basis willalso be examined.Learning Objectives - The attendee should be able to:•Analyze the de-centralization of clinical trials, evaluate virtual research tools, and identify barriers to virtual research participation.•Evaluate the elements of conducting decentralized clinical trials of FDA regulated investigational products while ensuring FDAregulations are met, including those covering human subject protection and electronic records.•Recognize the importance of diverse study participants in ensuring equitable and comprehensive research outcomes.•Assess compliance issues when using telemedicine in decentralized clinical trials.•Demonstrate the use of REDCap and apply strategies to ensure that only quali昀椀ed participants are enrolled in a clinical trial.•Evaluate different post-approval monitoring program structures, risk-based monitoring approaches, and present tools and tipsfor effectiveness.•Learn from experiences in creating a sustainable and scalable structure for an academic coordinating center.•Examine the impact of health disparities when engaging study participants and its effect on the validity, generalizability, andimpact of clinical research 昀椀ndings.•Develop strategies to enhance clinical trial recruitment by mitigating health literacy barriers.•Provide an overview of clinicaltrials.gov and best practices for trial registration.SOCRA designates this educational activity for a maximum of 12.5 Continuing Education Credits forSOCRA CE, Nurse CNE, and Physician CME.SOCRA designates this live activity for a maximum of 12.5 AMA PRA Category 1 Credit(s)™.Physicians should claim only the credit commensurate with the extent of their participation in the activity.CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council forContinuing Medical Education to provide continuing medical education for physicians.CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing educationby the American Nurses Credentialing Center's Commission on Accreditation. / SOCRA Course Series 300100SOCRA SOURCE © November 2024
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