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Fun with Clinical Research v2

Across
US Document required post IRB Approval & prior to use of ICF at site
Sponsor representative that coordinates & supervises activities for a clinical trial
Collaboration across Pharma companies to provide list of acceptable GCP certifications
Responsible for conduct of trial at site
Accompanies DILs
Describes objectives,design, methodology, and statistics of a trial
Document required prior to destruction of drug
Time recording system, performed monthly
Document containing compound safety profile
IVRS/IWRS generic term
Clinical Trial Assistant
Database which contains all SOPs, Global and Local
CSU Americas Group to contact for SOPs and Process issues
Sanofi preferred vendor for laboratory services
Visit report Writing system in IMPACT
Collection of documents to be audit/inspection ready at all times
Sanofi Learning Management System (for SOPs & Systems)
Sanofi primary CTMS
Local Trial Master File
FDA blacklist
Central access point to Sanofi applications
Defined event of special interest in a protocol
Down
Sponsor Representative for oversight of CRAs
Site Manager
Institutional Review Board
Temperature monitoring device used during shipment of IMP
Visit by outside Regulatory entity (ie FDA, Health Canada) examining compliance
Site Regulatory Binder
Confirmation that something has been received
Application to manage and grant access to systems
Sanofi Training provided by Brookwood
Sanofi Corporate Compliance Training System
QSD-001246
Reviewing study progress at a site
QSD-010955
US-CSU Headquarters
Provides assistance to sites for technology issues
Central Investigator database in CTMS
Document that describes the trial to the subject
Responsible for Study management
Canadian Sanofi Headquarters
Visit by Internal Sanofi QA entity reviewing compliance
RDC/eCRF within Unify platform