Acronyms
COV
What is the close-out visit?
Responsible for IIP review and approval process through the life cycle of the study IRB/IEC submission and approval activities (country dependent).
Who is the Site Activation Partner (SAP)?
The study specific training platform.
What is Firecrest?
eTMF
What is the Electronic Trial Master File?
Provides support for specified administrative tasks at the country and site level on all Internalized (SUI) and GSSO Insourced (Model 1) studies.
What is the Pfizer Clinical Trial Assistant (CTA)?
The authoritative system for the final TMF documents that support clinical trials in scope of CT01. It is Pfizer’s central file management tool, and one of the premier inspection readiness tools.
What is pTMF?
DIL
What is the Dear Investigator Letter?
For all studies, manage the Per Subject Cost development process for original and amended protocols.
Who is the Pfizer Investigator Contracts Lead (ICL)?
The reporting system for IMPALA which generates reports to view Investigational Product (IP) shipment, inventory, user account/access, IP dispensed etc.
What is iView2?
CMPT
What is clinical monitoring plan template?
Role is applicable to GSSO Insourced Model only. Provides operational leadership throughout the study lifecycle, with accountability for oversight and execution of clinical trials globally.
Who is the Pfizer Global Study Manager (GSM)?
The system used by study teams to record data generated during the conduct of a clinical trial and is required to manage study execution (e.g., study, site, organization, personnel, monitoring, and oversight assignments and reporting.
What Siebel Clinical Trial Management
AECI
What is adverse event of clinical interest?
Completes and documents required INV02 Due Diligence checks for PIs and Sub-Is.
Who is the Pfizer Due Diligence Specialist?
Operational clinical trial information will be entered into Siebel CTMS then will be aggregated and available for review and reporting in this system.
What is ODR?