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Fun with Clinical Research

Horizontales
Sanofi primary CTMS
Defined event of special interest in a protocol.
Responsible for Study management
Collaboration across Pharma companies to provide list of acceptable GCP certifications
Canadian Sanofi Headquarters
Application to manage and grant access to systems
Group to contact for quality related issues
Site Regulatory Binder
QSD-001246
CTMS for Medical Affairs studies
R&D Time recording system, performed monthly
Document containing compound safety profile
IVRS/IWRS generic term
QSD-002056
Document that describes the trial to the subject.
RDC/eCRF within Unify platform
Sanofi Learning Management System
Site Manager
Sponsor Representative for oversight of CRAs
Confirmation that something has been received.
Describes objectives,design, methodology, & statistics of a trial
System for locating Global SOP
Collection of documents to be audit/inspection ready at all times
Accompanies DILs
Verticales
Sanofi preferred vendor for laboratory services
FDA blacklist
Visit by outside entity (ie FDA) examining compliance
Central Investigator database in CTMS
Document required prior to destruction of drug.
Institutional Review Board
Temperature monitoring device used during shipment of IMP
Visit by Internal QA entity reviewing compliance
Local Trial Master File
Provides assistance to sites for technology issues
Reviewing study progress at a site
Document required prior to ICF implementation
Responsible for conduct of trial at site
Central access point to Sanofi applications & training
US-CSU Headquarters
Sponsor representative that coordinates & supervises activities for a clinical trial.
Visit report Writing system in IMPACT
Trial Assistant
Sanofi Training provided by Brookwood