Study: Certified CRAs on Average Perform Better than Non-Certified CRAs

Data Show Better Performance Related to Informed Consent Findings, Protocol Compliance, and More

Data collected and analyzed by CRA Assessments, LLC and the Association of Clinical Research Professionals (ACRP) show Clinical Research Associates (CRAs) certified by ACRP on average perform better than their non-certified counterparts in key competencies related to monitoring clinical trials.

“Sponsors, CROs, sites and other partners in the clinical research process can rest assured that professionals whose competence has been validated through ACRP Certification will on average perform better than those who have not achieved ACRP Certification,” says Jim Kremidas, ACRP Executive Director.

Study data was collected through CRA Assessments’ proprietary web-based assessment tool that tasks CRAs to identify issues within a simulated monitoring visit environment.

Key Findings

Analysis of the blinded data collected from more than 500 U.S. and Canadian CRAs of varying experience levels shows Certified Clinical Research Associates (CCRA®) on average identified more study-related issues than their non-certified counterparts, including:

  • 14% More Informed Consent Findings
  • 10% More Protocol Compliance Findings
  • 26% More IRB Submission and Approval Findings
  • 23% More Source Documentation and Source Data Verification Findings
  • 19% More Potential Fraud, Scientific Misconduct, and Delegation of Authority Findings

“CRAs play one of the most critical roles in clinical research by ensuring GCP compliance, protocol compliance, and data quality,” notes Gerald DeWolfe, Chief Executive Officer of the Austin, TX-based CRA Assessments. “Our new analysis clearly shows that on average the CRA role is better played by CRAs whose competence has been validated through ACRP’s certification exams.”

“While our data shows CCRA®s on average perform better than their non-certified colleagues, the mean values and significant ranges show that improvement can be made in several key competencies,” DeWolfe adds. “Our conclusion is that the current industry model of competence evaluation through oversight visits does not objectively assess competence in the CRA workforce. To efficiently and effectively improve CRA performance, we as an industry need to better leverage independent competence assessment and validation.”