How Electronic Data Collection Helps Meet the FDA's Quality Guidelines

April 15, 2016

Offering guidance for generating strong evidence in clinical research, the acronym "ALCOA" is widely used to outline the FDA's fundamental elements of quality for clinical data. 

CRF Health VP of Quality Assurance, Bob Murray, details the individual components of ALCOA and describes how capturing clinical outcomes data electronically helps trial sponsors meet and exceed each guideline.

Previous
Understanding the EMA Oncology PRO Guideline Appendix – We Can Help!
Understanding the EMA Oncology PRO Guideline Appendix – We Can Help!

Next
Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes
Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes

Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the pa...