These videos provide guidance for site staff on the background and rationale and safety management for the TRACK trial
The TRACK Trial
Background and Rationale
Safety Management Part A
Safety Management Part B
Study Procedures
Participant Information
Participant Retention Strategies
The TRACK Trial
Background and Rationale
Safety Management Part A
This video is the first of a two part series on Safety Management in the TRACK trial.
Part A covers the classification and reporting of adverse events.
Safety Management Part B
This video is the second of a two part series on Safety Management in the TRACK trial.
Part B covers the identification of Serious adverse events, as well as pregnancy reporting, follow-up of safety events, clinical outcome reviews, and emergency unblinding.
Study Procedures
Participant Information
Participant Retention Strategies