In an era of intensive regulatory oversight and digital transformation, research and business records are more than administrative paperwork—they are legal evidence, compliance lifelines, and the backbone of scientific integrity.
This course provides a deep, practical, and legal exploration of recordkeeping and data management systems essential for compliance with U.S. and international standards. Covering federal regulations (e.g., 21 C.F.R. Part 11, 42 C.F.R. Part 93, 2 C.F.R. Part 200, HIPAA, GDPR) and industry-specific requirements (GLP, GCP, GMP), it teaches participants to design, implement, and monitor robust recordkeeping frameworks that protect data integrity, support audits, and ensure transparency.
Ideal for research administrators, compliance officers, scientists, clinical trial managers, IT/data security professionals, and institutional leaders, this course integrates legal mandates, best practices, and emerging technologies (AI, blockchain, cloud computing) to prepare students to meet the highest standards of accountability and reproducibility.
Course Objectives
By the end of this course, participants will be able to:
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Understand the legal and regulatory requirements for recordkeeping and data management across research, healthcare, academic, and commercial settings.
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Design and implement compliant recordkeeping systems—covering electronic records, laboratory notebooks, clinical data, and administrative documents.
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Ensure data integrity and authenticity using internationally recognized standards such as ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
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Prepare for inspections, audits, and investigations by agencies such as FDA, NIH/ORI, NSF OIG, and foreign regulators.
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Manage data privacy and cybersecurity risks, including HIPAA, GDPR, and emerging AI-related obligations.
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Plan for long-term preservation, archiving, and responsible disposal to meet both scientific and legal needs.
