Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

Duration: 60 Minutes
Did you know that Electronic Health Record (EHR) can be used in prospective clinical investigations of human drugs, biologics, medical devices and combination products regulated by the US Food and Drug Administration (FDA)? This includes foreign studies used in support of an application for marketing approval of the medical product. This webinar will discuss FDA's current recommendations on using Electronic Health Records in prospective clinical investigations of human drugs, biologics, medical devices and combination products. A refresher on key requirements for Computer Systems used in Clinical Investigations is also included.
EHR in FDA Clinical Investigations
Instructor: Rachelle D'Souza
Product ID: 505427
Objectives of the Presentation
  • Whether and how to use EHRs as a source of data in clinical investigations
  • Using EHRs that are interoperable with electronic systems supporting clinical investigations
  • Ensuring the quality and integrity of EHR data that are collected and used as electronic source data in clinical investigations
  • Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA's inspection, record keeping and record retention requirements
Gain a Refresher on key requirements for Computer Systems used in Clinical Investigations

Why Should you Attend
This training includes FDA's current recommendations on the use of Electronic Health Records (EHR) in clinical investigations and a refresher on key requirements for Computer Systems used in Clinical Investigations. Check out the key learning objectives and specific areas covered in this context. If you are a sponsor of a clinical trial involving a drug, biologic, medical device or combination product, a clinical investigator, a Contract Research Organization (CRO) or an Institutional Review Board (IRB), you stand to benefit from this training.

Areas Covered
  • EHRs & EDC Systems
  • Types of EHRs
  • Applicability of FDA recommendations RE: EHR & Clinical Investigations
  • Advantages of EHR & Clinical Investigations
  • Interoperability between EHR & EDC Systems including Advantages & Challenges
  • ยง11 & Applicability to EHR
  • ALCOA - Data Quality of EHRs as Clinical Source Data
  • ONC Health IT Certification of EHR technology, Alternative Controls or Risk Analysis & Regulatory Implications
  • Data Management Plan
  • EHR Data Changes
  • Audit Trails
  • Informed Consent
  • Privacy & Security Safeguards
  • Inspection, Record Keeping & Retention
  • Refresher of key requirements for computer systems used in clinical investigations
Who will Benefit
  • Sponsors of clinical trials (drug, biologic, medical device & combination product manufacturers)
  • Pharma, Biotech Medical Device manufacturers including start-up CEOs, Product Managers, COOs, Founders, Co-Founders, Executive & Management Staff
  • Clinical Investigators (physicians)
  • Contract Research Organizations (CROs)
  • Institutional Review Boards (IRB) / Ethics Review Boards (ERB) / Research Ethics Boards (REB)
  • Clinical Research Associates
  • Project Managers
  • Principal Investigators
  • Clinical Research Coordinators
  • Regulatory Affairs, Quality Assurance, Clinical Trial Professionals
  • Academic Medical Center and Research Institution Professionals supporting clinical research
  • Personnel responsible for ensuring compliance with GCP regulations
$375
Recorded Session for one participant
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  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety/pharmacovigilance and medical information systems

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets like Canada, USA, EU, China, Japan, Australia and New Zealand.
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