Electronic Health Records (EHR) in clinical trials

Electronic Health Records (EHR) are standard instruments used to capture patient encounter data in clinical practice. They offer some key benefits in relation to clinical trials by supporting : 1. Increased patient recruitment, 2. Increased physician participation.

Study Set-up

• Query EHR database to establish number of potential study candidates.
• Incorporate study manual or special instructions into EHR “clinical content”for study encounters

Study execution

• Incorporate study-specific data capture (just as you would do with a CRF in a clinical trial) as part of routine clinical care / clinical documentation workflow.
• Auto-populate study data elements (for example demographics) into CRFs from other parts of the EHR database.
• Embed study-specific data requirements (modules not already included in the EHR) as special tabs/documentation templates using structured data entry.
• Implement rules/alerts to ensure compliance with study data collection requirements (EHR systems have inbuilt validation checks)
• Create range checks and structured documentation checks to ensure valid data entry

Study Enrollment

• Implement study screening parameters into patient registration and scheduling.
• Query EHR database to contact/recruit potential candidates and notify the patient’s provider(s) of potential study eligibility.

Submission & Reporting

• Provide data extraction formats that support data exchange standards (for example CDISC)
• Document and report adverse events (Note : EHRs often use ICD-9/10 coding, while CRFs would need MedDRA codes)