This process begins with an email from the TMF Process Owner to the CPM regarding their study begin selected for GFL
What is the assignment and initiation of CPM and Study Team to GFL
100
In order to begin answering the GFL WIZARD questions, you will need this
What is the Final Approved Protocol
100
These 2 documents can answer the following GFL WIZARD question:
Will subject diaries or questionnaires be used in this study?
What is the Protocol and Study Monitoring Plan
100
This system is used to identify actual site milestone dates
What is ClinRepNet
100
These are the 4 main critical changes currently identified when assessing and implementing document list changes from the CT01 summary of changes
What is TMF Spec, Milestones, New Document Types, New Legacy Doc Types
200
Initial set up of the study specific document list is considered endorsed once confirmation is received from CPM or no response is communicated after this many days
What is 5 days
200
This is the expected time frame to have all study and country level questions answered utilizing the WIZARD
What is study milestone FSFV
200
This section of a protocol can answer the following GFL WIZARD question:
Will pharmacogenomic samples be collected at non-PCRU sites?
What is Assessments
200
The TMF Study Owner should review EPM for protocol milestones this frequently
What is Monthly
200
For changes that do not require assessment from the study team, but still require a CPM to review them, these will be addressed via this
What is te Operational Report
300
This process begins after the creation of the initial study specific document list through closeout of the TMF at the end of the study
What is Document List Maintenance
300
In assisting you with answering WIZARD questions, the Study Team SharePoint site will provide you with these 3 things
What is the Study Monitoring Plan, Vendor Contacts and Team Roster
300
In this section of the protocol, you can find information about drugs being utilized for a study
What is Study Treatments
300
In ClinRepNet, this date should be used for IIP approval
What is Packaged Approved by IRM Date
300
This critical change may be reflected in the GFL Tracking Tool
What is Milestone change
400
In addition to assisting the Study Owners with managing their studies, this tool enables management to track progress on GFL and to help identify gaps in the process
What is the Study Status Tracker
400
On the GFL WIZARD this tab is pre-populated with a "Y" in the "Required for Study" column to be assessed with the study team quarterly
What is the Site-Specific Tab
400
This section of the protocol helps to identify the Study phase, duration and population
What is Study Design
400
Even though you don't have an actual protocol level milestone date, you can do the following
What is add projected milestone dates from EPM
400
The TMF Study Owner should address critical changes with their CPM/Study Team within this timeframe
What is 2 weeks after changes are received
500
This process includes monitoring performance of the sub-set documents and conducting health checks on a regular basis until the end of the study
What is Metrics and Reporting
500
After 2 emails have gone out to the functional line to assess GFL WIZARD questions and still no response is received, the document types in question will need to be marked as this
What is Required
500
This section of the protocol can answer the following GFL WIZARD question:
Will subjects be dosed with or exposed to investigational products in this study
What is Adverse Event Reporting
500
This role is responsible for entering actual site milestone dates from ClinRepNet
Who is the TMF Document Specialist
500
All non-core new document types (including new legacy) need to be addressed with these roles