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Hi Maria,
1. All safety related email communications should be filed to Zone 07 Artifact 07.03.01.
2. Yes, all safety notifications to IRB or IEC and Regulatory are required to be file under 04.03.01 and 03.03.01 respectively.
3. Documents which needs review and approval from RA and EC should be filed under Submission classification. Even other essential notifications rather than safety also need to be filed under Submission.
4. Notification of trial termination artifact should include only end of trial notification correspondence and related documents. Other documents related to other event required to classified as per content.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.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”.