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

Description

Description

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.

Areas Covered in the Webinar:

FDA Recommendations on

• 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

Why Should You Attend:

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 training provides FDA’s current recommendations on this topic. Check out the specific areas covered below. 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.

Who Will Benefit:

• Sponsors of clinical trials (drug, biologic, medical device & combination product manufacturers)
• Clinical Investigators (physicians)
• Contract Research Organizations (CROs)
• Institutional Review Boards (IRB) / Ethics Review Boards (ERB) / Research Ethics Boards (REB)