November 2024 SOCRA Source Journal - Journal - Page 100
‘Hot Topics’ and Practical Considerations for
Protecting Human Research Participants
IN-PERSON
MAY 8 & 9, 2025 | SAVANNAH, GA
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:
•
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 FDA
regulations 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 tips
for 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, and
impact 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 for
SOCRA 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 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
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SOCRA SOURCE © November 2024
