The TMF Index should be the simplest tool you use during your clinical trial, but unfortunately that is not always the case. TMF Indices have been used as somewhat of a loose tool that is not utilized as often as it should due to lack of training, ov
The TMF Index is a key tool that should be used when navigating throughout the TMF - from confirming a document location to performing a Quality Check review. Generally, the TMF Index is based on the CDISC TMF Reference Model, which provides a good foundation of what documentation you could expect during a clinical trial. The TMF Index should be the simplest tool you use during your clinical trial, but unfortunately that is not always the case. TMF Indexes have been used as somewhat of a loose tool that is not utilized as often as it should due to lack of training, overwhelming sizes, “memorization”, or forgetfulness. During this session, I will discuss how to make your TMF Index work for you through all aspects while addressing some of the worst and best industry practices when developing and using the TMF Index. We will cover the following:
· What are components of a good TMF Index?
· Sub artifacts: To use or not to use?
· TMF Index Training
· Utilizing a TMF Index during Quality Checks
· Making good use of your annual reviews
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