Roles
What level does the CTL sit on?
1. Project
2. Local/Country
3. Trial
Trial level
What system has your learning plan in it?
LOS
Who writes the Clinical Trial Protocol? (CTP)
CTL/ Trial Medical Writer
What team can assist you with questions regarding TMF?
1. Site Enablement
2. Site Monitoring
3. CO BusOps
CO Bus Operations
What should your zoom be set at in LOS?
100%
What level does the TMM ( Team Member Medicine) or CPL (Clinical Project Lead) sit on?
1. Trial Level
2. Local/Country Level
3. Project level
Project Level
What is the name of the BI Portal System used for document exchange?
Clinergize
What is the non final Clinical Trial Protocol Called?
Draft Protocol
What team has the CRAs in it?
1.Study Management and Conduct
2. Medical Writing
3. Site Monitoring
Site Monitoring
How do you encrypt and email to a site?
1.<private>
2.<confidential>
3.<encrypt>
<confidential>
What level does the MRA sit on?
1.Trial Level
2. Country/Local Level
3. Project level
Country/Local Level
What is the system that is made up of 5 subsystems?
BICMTS
What does TDO stand for?
Trial Design Outline
What team has the CAs and MRAs in it?
1. Site Enablement
2. Site Feasibility
3. Study Management & Conduct
Study Management & Conduct
What level does the SML sit on?
1. Project Level
2. Country /Local Level
3. Trial Level
Trial Level, they sit on same level as the CTL
What system is where the PI enter their CRFs (Case Report Forms)?
BRAVE
What occurs first the TDO or the creation of the CTP?
The TDO must be finalized prior to the CTP creation beginning
What team assist the CTMs with Regulatory Document Collection?
1. Site Enablement
2. Site Feasibility
3. Site Monitoring
Site Enablement
Yes
What level does the Site Monitoring Manager sit on?
1. Country/Local Level
2. Project Level
3. Trial Level
Country/Local Level
What system do MRAs enter their time into?
TimeRecorder
What does PAM stand for?
Protocol Alignment Meeting
What team has colleagues to help you with non-compliances?
1. Site Feasibility
2. Training & Process Control
3. Site Monitoring
Training & Process Control
Name one thing the SMM is responsible for?
Overseeing the issues and site visit reports that the CRAs submit. Provide input on Medical Quality Review Meetings. Can act as SML in certain circumstances.