Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations 2017 is a webinar that covers topics such as:
- Using EHRs that are interoperable with electronic systems supporting clinical investigations
- Whether and how to use EHRs as a source of 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
- Ensuring the quality and integrity of EHR data that are collected and used as electronic source data in clinical investigations
- Retention requirements
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations 2017 is intended for:
- Clinical Investigators (physicians)
- Ponsors of clinical trials (drug, biologic, medical device & combination product manufacturers)
- Institutional Review Boards (IRB) / Ethics Review Boards (ERB) / Research Ethics Boards (REB)
- Contract Research Organizations (CROs)