What is the best artifact for the PK Plan? my though is to archive in zone 8 (Lab) but my CPM’s suggestion is to archive in the artifact 11.01.01 because is mentioned in the SAP, our statistician do not agree. what do you think? thanks.
Below an abstract from the doc:
The purpose of this PKAP is to provide all information that is necessary to perform the required pharmacokinetic analyses for data from the study. This PKAP will describe how to produce summary tables, figures and listings that will be included in the PK report for this study at the interim PK analysis and at the final PK analysis.
I have always used Zone 8. It order to really know what artifact to use, look at the info within the plan and match the content description to the reference model. Plans that i have looked at in the past describe methods, validation, etc. which is more in line with section 8.
02 Central Trial Documents 02,03 Reports 02.03.02 Bioanalytical Report To present & summarize the relevant top line findings of the bioanalytical aspects of the interim or final analysis and may include PK analysis or reports. “Bioanalytical Report