August 2024 SOCRA Source Journal - Journal - Page 85
‘Hot Topics’ and Practical Considerations for
Protecting Human Research Participants
MAY 16 & 17, 2024 | SCOTTSDALE, AZ
Workshop 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 ICH
GCP and the Code of Federal regulations guide and direct investigator and sponsor responsibilities related to post
approval monitoring, modernizing consent, adherence to clinicaltrials.gov and the NIH Data Management and Sharing
policy. 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 the
protection 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, future
use of stored bio-specimens, and risk-based monitoring communication. Discussion surrounding research in the virtual
world since the recent pandemic and pain points that continue after the implementation of the Common Rule revisions
will be explored. Insights about establishing a robust educational program and accessing effectiveness of the program
on an ongoing basis will also be examined.
The program will identify best practices and strategies to provide potential solutions for these challenges. Insights
about establishing a robust educational program and accessing effectiveness of the program on an ongoing basis will
also be examined.
Learning Objectives - The attendee should be able to:
• Discuss challenges with informed consent, identify recommendations to improve and modernize informed consent
documents, and the consent process
• Describe the role and responsibilities of the Research Participant Advocate in the informed consent process
• Describe the myriad of challenges associated with successful implementation of informed consent in research
including vulnerable populations
• Discuss Gene Therapy and the current regulatory environment
• Discuss different post approval monitoring program structures, risk-based monitoring approaches, and present tools
and tips for effectiveness
• Discuss the bene昀椀ts of certain changes in the Common Rule revisions
• Identity and navigate pain points that still exist in the regulation, post Common Rule revisions
• Provide clinicaltrials.gov overview and best practice for trial registration
• Discuss the Institutional Review Board regulations and federal policies for single IRB
• Identify how single IRB has affected roles and responsibilities of IRBs, relying institutions, study teams
• Develop strategies for successfully navigating the single IRB process
• De昀椀ne which NIH studies are required to share data
• Identify the elements of a data management sharing (DMS) plan and apply strategies for creating a DMS plan
• Discuss required training and documentation in the research arena.
SOCRA designates this educational activity for a maximum of 13.5 Continuing Education Credits for
SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 13.5 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 for
Continuing 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 education
by the American Nurses Credentialing Center's Commission on Accreditation. / SOCRA Course Series 300
SOCRA SOURCE © May 2024
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