Clinical Trials – Computerized Systems

The Food and Drug Administration (FDA) established the Bioresearch Monitoring (BIMO) program of inspections and audits to monitor the conduct and reporting of clinical trials to ensure that data from these clinical trials meet the highest standards of quality and integrity and conform to FDA’s regulations. Computerized systems used in clinical trials refer to theContinue reading “Clinical Trials – Computerized Systems”

Before Your Trial Goes Live – InForm FastStart

When EDC is used in a clinical trial, electronic case report form (e-CRF) data are defined to be the data that are manually entered into a computer by the patient or by the investigator’s staff. CDISC defines e-CRF as a CRF in which related data items and their associated comments, notes, and signatures are linkedContinue reading “Before Your Trial Goes Live – InForm FastStart”