Clinical Trials and Publication of Results
US FDA norms on electronic source data in clinical investigations seen to ensure transparency & traceability |
Nandita Vijay, Bengaluru |
The US Food and Drugs Administration (FDA) has issued norms on guidance for Industry on the Electronic Source Data in Clinical Investigations. It has clearly defined its recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. |