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Jul 2016


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New Part 11 Guidance for Clinical Trials: What This Means for You- By Compliance Global Inc.

Online Event



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.

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,
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

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.

For more detail please click on this below link:

Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510




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