eTMF
What is the Amgen standard metric goal for eTMF timeliness?
>=90%
Which tab would you use to enter an end date of a CST member?
Study Team Management tab
What is a common central lab vendor used in clinical research?
LabCorp
These are two priorities in risk-based trial management.
Patient Safety and Data Integrity
Who's responsibility is it to review and approve budgets?
Study Delivery Manager (SDM)
When you need to request deletion of minor document versions with closed DQIs, where do you direct your request?
Business Support Center (BSC)
What is the new eClinical system we are migrating to?
Veeva CTMS
This document should outline the scope of work, responsibilities, timelines and deliverables for a vendor.
This process aligns level of risk-based liklihood.
Risk Based Assessment/Analysis
What role oversees the CRAs in their specific region?
LSOM
Which identifier helps classify where a document belongs in the eTMF?
The TMF Index
Under which tab would you find the trip reports displaying monitoring visit dates?
Site Contacts and Visits Tab
(click on site first to do this)
A vendor consistently missing deadlines may require this formal correcting process.
CAPA
If there are trends in missing data across multiple sites, what is your first step in finding the problem.
Root Cause Analysis
Who conducts site visits, conducts SDV/SDR, resolves data queries?
CRA
What system is used to grant eTMF access?
eTMF MyAccess Portal
What are the ACT FAST learning days?
June 8th and 9th
This process ensures vendors are performing to vendor contracts and trial needs/expectations.
Vendor Oversight
This role ensures risks are monitored and escalated appropriately.
Clinical Risk Manager (CRM)/Study Delivery Manager (SDM)
Who oversees multiple studies at the program level and higher level budegts?
Clinical Program Manager (CPM)
What is the process for reclassifying a document in eTMF?
Submitting a DQI in Veeva Vault
CTMS and eTMF are often used together to ensure operational data aligns with ___________.
Inspection Readiness
This role is accountable for ensuring vendor deliverables.
Who is the sponsor/study delivery manager (SDM).
What is the platform used to identify risks?
CT-RACT
Who manages data cleaning, query resolution and ensures database lock?
Data Management