New Part 11 Guidance for Clinical Trials: What This Means for You

Why Should You Attend:

FDA regulations related to Good Clinical Practices includes Electronic Records and Electronic Signatures. Governing those is 21 CFR Part II. The Department of Health and Human Service equivalent to this regulation is 45 CFR 142 Security and Electronic Signature Standards and 45 CFR 160 and 162 Health Insurance Reform: Standards for Electronic Transactions.

This 60-minute webinar will help you to be aware of these regulations and what that means for your organization and study. For instance, you wish to scan your case report forms and keep them in an electronic format. Is this acceptable? A research participant wishes to email back his signed consent form. Is this acceptable? Are you set up to receive such documents? Information provided in this webinar will help answer these questions and more, and help you work through other complex scenarios that may arise.

Areas Covered in the Webinar:

• Requirements of 21 CFR Part 11
• Requirements of 45 CFR 142 and 160
• Electronic records:
• Why duties must be segregated to ensure integrity of data,
• Logins,
• Passwords and individual accounts:
• who needs them,
• how often to use,
• Data entry: proper protocol to follow for source data.
• Tips to get all staff on board in limiting access to authorized personnel only

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Human subjects research personnel
• Clinical research coordinators
• Investigators
• Administration in charge of clinical research
• Regulatory affairs
• Personnel involved in health plans and health care clearing houses
• IT/ IS
• Documentation
• Software vendors

Instructor Profile:

Dr. Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University.

Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, she was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

Topic Background:

These rules “propose standards for the security of individual health information and electronic signature use by health plans, health care clearinghouses, and health care providers. The health plans, health care clearinghouses, and health care providers would use the security standards to develop and maintain the security of all electronic individual health information. The electronic signature standard is applicable only with respect to use with the specific transactions defined in the Health Insurance Portability and Accountability Act of 1996, and when it has been determined that an electronic signature must be used.”

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