Published on: January 20, 2025
On January 20, 2025, the Department of Clinical Research at the Himalayan Institute of Medical Sciences organized an engaging guest lecture titled “Ensuring Data Integrity and Addressing Compliance Issues and Non-Compliance.” The session was led by Dr. Manoj Karwa, Head of Clinical Trials and Pharmacovigilance at Auriga Research Pvt. Ltd., and attended by 31 students.
Dr. Karwa emphasized the critical importance of maintaining data integrity and compliance in clinical research to uphold ethical standards and credible study outcomes. The lecture covered key areas such as identifying and managing protocol deviations, strategies for addressing non-compliance, and implementing Corrective and Preventive Actions (CAPA) to resolve and prevent recurrence of issues.
Participants learned practical approaches including early detection and documentation of compliance issues, thorough root cause analysis, transparent communication with stakeholders, and continuous staff training. The session also highlighted the role of regular audits and follow-up to sustain compliance and foster trust in research processes.
An interactive Q&A enriched the session, allowing participants to clarify doubts and engage deeply with the topic.
The lecture received highly positive feedback, with attendees appreciating Dr. Karwa’s clear explanation of complex regulatory and ethical concepts alongside actionable insights.
The session concluded with a vote of thanks by Dr. Nikku Yadav, Incharge of the Department of Clinical Research, expressing gratitude for the expert guidance provided.
“Dr. Manoj Karwa provides an insightful lecture on maintaining data integrity and effectively managing compliance and non-compliance challenges.”
“Dr. Manoj Karwa delivering an insightful online lecture on ensuring data integrity and navigating compliance and non-compliance challenges.”
This lecture reinforced the foundation for trustworthy clinical research by underscoring vigilant data management, proactive compliance monitoring, and fostering a culture of accountability critical to advancing ethical and impactful scientific studies.
