I'd like your view on what the DV dataset should include.
The implementation guide says "The DV domain is an Events model for collected protocol deviations and not for derived protocol deviations that are more likely to be part of analysis".
1. Does "collected protocol deviation" mean those deviations highlighted by the CRAs and collected in the monitoring deviation log?
1.a If so, the DVDECOD can be standardize defining a set of values that the CRAs can select during the set up phase of the study, but what about the DVTERM?
Indeed the monitoring deviation log includes misspellings, errors and very long or suboptimal text.
2. What is the link between the SDTM.DV and the ADAM.DV? Should the ADAM include only those deviations that are judged as minor or major during the Blind Review Meeting? Should the DVTERM be the same as the one reported in the SDTM.DV or can it be defined during the Blind Review Meeting with the aim to simplify and make clearer the text?
Thank you in advance for sharing your experiences and views on this matter.
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Dears,
I'd like your view on what the DV dataset should include.
The implementation guide says "The DV domain is an Events model for collected protocol deviations and not for derived protocol deviations that are more likely to be part of analysis".
1. Does "collected protocol deviation" mean those deviations highlighted by the CRAs and collected in the monitoring deviation log?
1.a If so, the DVDECOD can be standardize defining a set of values that the CRAs can select during the set up phase of the study, but what about the DVTERM?
Indeed the monitoring deviation log includes misspellings, errors and very long or suboptimal text.
2. What is the link between the SDTM.DV and the ADAM.DV? Should the ADAM include only those deviations that are judged as minor or major during the Blind Review Meeting? Should the DVTERM be the same as the one reported in the SDTM.DV or can it be defined during the Blind Review Meeting with the aim to simplify and make clearer the text?
Thank you in advance for sharing your experiences and views on this matter.
Regards
Elena