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

  • ID: 4278115
  • Webinar
  • June 2017
  • Region: Global
  • 60 Minutes
  • Online Compliance Panel
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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.

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
- §11 & 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
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  • Rachelle D’Souza Rachelle D’Souza,


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  • 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
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