Auditeur, GCP Responsibilities The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, « ICH Good Clinical Practice: Ligne directrice consolidée, » (GCP), soutenir un programme d’assurance qualité (Assurance qualité) to ensure that AGN project data and summary statements are of known and documented quality. Summary of Responsibilities: Lire la suite
Responsibilities The Director, GCP sera tenu de tout superviser et de participer à, audit d’assurance qualité de toutes les activités soumises à la, « ICH Bonnes pratiques cliniques/de laboratoire: Ligne directrice consolidée, » (BPC/BPL’s), soutenir un programme d’assurance qualité (Assurance qualité) to ensure that Allergan project data and summary statements are of known and documented Lire la suite
Responsibilities Assisting in the design and execution of high quality clinical studies in compliance with FDA and ICH requirements. Function as a primary liaison to clinical investigators/site staff. Identify, qualify, initiate, monitor and close out clinical sites. Co-monitor with CRO when issues arise with the site. Assist in the selection Lire la suite
GCP Audit. Part C. Cours d'audit GCP. Data Fabrication and Falsification. Access granted on May 08,2023