FDA REGULATIONS RELATED TO GOOD CLINICAL PRACTICES 2016 - New Part 11 Guidance for Clinical Trials: What This Means for You - By Compliance Global Inc

Website https://complianceglobal.us/product/700468/SarahFowler-Dixon/new-part-%2011-%20guidance-for-clinical | Edit Freely

Category Education; E-Learning

Deadline: July 20, 2016 | Date: July 20, 2016

Venue/Country: online webinar, U.S.A

Updated: 2016-06-28 19:26:53 (GMT+9)

Call For Papers - CFP

FDA regulations related to Good Clinical Practices includes Electronic Medical 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.

These Electronic health record 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 patient records. 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.” 45 CFR 142.

Why Should You Attend:

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 an acceptable good clinical practice? Are you set up to receive such documents?

Information provided in this webinar will help answer these questions and help you work through other clinical data management scenarios that may arise.

Areas Covered in this Webinar:

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

Learning Objectives:

Requirements of 21 CFR Part 11

Requirements of 45 CFR 142 and 160

Who Will Benefit:

Human Subjects Research

Clinical Research Coordinator Positions

Investigator Positions

Administration in charge of Clinical Research

Regulatory Compliance Personnel

Those involved in Health Plans and Health Care clearinghouses

For more information, please visit : https://complianceglobal.us/product/700468/SarahFowler-Dixon/new-part-%2011-%20guidance-for-clinical%20-trials/1

Email: supportcomplianceglobal.us

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Level:

Intermediate

Speaker Profile:

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, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.