[Vaibhav Funde]

Hi Christina,
Artifact 06.03.01 (IP Treatment Allocation Documentation) is related to Investigational Product related documentation, Zone 06 covers all types of log used for accountability and tracking of Investigational Product.
Where Artifact 11.02.03 is related to Statistical programming Documentation generated for Investigational Product.
Artifact 06.03.01 is used for filling documents related to IP Treatment Allocation Documentation Kit List, Randomization Envelopes, Randomization List.
Artifact 11.02.03 is used for Master Randomization List created for study protocol which is The single source on the assignment of subjects to protocol specified groups. In blinded studies, this list remains blinded until its release following the final data lock.
As per my understanding artifact 06.03.01 is applicable for all study which have randomization procedure.
Hope so this information will help to distinguish between zone 06 related artifacts and zone 11 related artifacts.
Thank you.
With Regards.
Vaibhav Funde.

[Vaibhav Funde]

Protocol Deviations Guidelines for CRAs if this document is created specifically for training purpose of CRAs then we can use artifact “01.04.02 – Trial Team Training Material”.

[Vaibhav Funde]

Best place to file such communication is “07.02.04 – Special Events of Interest. As per above information EDC generated notification required corresponding communication from sponsor which suits this artifact defination.

[Author]

Posts