GCP
The safety and well-being of the trial subjects
What is the most important consideration during a Clinical Trial?
Completeness
What metric measures the total number of final documents out of the total number of documents expected?
Transmitter
Who uploads documents to PhlexTMF?
If it isn't __________, it did not happen!!
Documented
ELNOMEIST
Milestone
The only individual at the site designated to delegate authority.
Who is the Principal Investigator?
Kate Haviland
Who is the CEO of Blueprint Medicines?
The Global Consortium who partnered with the TMF Reference Model
What/Who is CDISC?
Within 35 days
What is the timeline for submitting documents to the eTMF?
BDUDINLNE
UNBLINDED
E6
Which section under ICH Efficacy, serves as guidelines for all EU member states?
The ----------- provides a high-level indication of the Study’s TMF Health, and ultimately, it’s Inspection Readiness.
TMF METRICS REPORT
List of SOPs Current During Trial
What artifact is filed in section 01.01.04 as per the reference model?
A collection of documents, images and content (data) that must be collected throughout the course of a clinical trial and retained after the completion of the trial.
What is the TMF?
SAMTSGNENSI
ASSIGNMENTS
Enrolling a subject that does not meet one inclusion critieria.
What can be defined as a Protocol Deviation?
Attributable, Legible, Contemporaneous, Original, Accurate
What is ALCOA?
Seven
How many studies are currently set up/active in PhlexTMF?
"used to measure progress of the study, as well as identify what documents should be available in the TMF at study, country and site level."
What is a milestone?
FTM HANCMPOI
TMF CHAMPION
Thirteen
How many principles of GCP are there?
A global, fully integrated biopharmaceutical company
Who are Blueprint Medicines?
05.04.03
What section is the Monitoring Visit Report filed, in accordance with the reference model?
A guide provided to our CRO partners detailing Blueprint’s expectations regarding TMF management.
What is the CRO playbook?
ETSEILSMIN