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WCG Publishes Safety Reference Model Operational Guide

Was developed in response to the critical need to harmonize safety reporting processes from regulators and across sponsors and CROs.

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By: Kristin Brooks

Managing Editor, Contract Pharma

WCG, a provider of clinical research solutions, published the Safety Reference Model. A first-of-its-kind operational guide for handling safety reporting to investigators, ethics committees, and competent authorities, the Safety Reference Model (SRM) was developed in response to the critical need to harmonize safety reporting processes from regulators and across sponsors and CROs, all of which are using different interpretations of high-level regulations in each country with active trials.   I...

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