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Overall Number of Baseline Participants in RRF is synced to Number of subjects in Reporting groups in the ERF

Written by Gemma
Updated over 5 months ago

Issue:

If the number participants that started a period in the Participant Flow of the RRF is different from the Overall Number of Baseline Participants in the RRF then when the RRF is synced to the ERF, the number participants that started a period in the Participant Flow of the RRF is synced to the number participants that started a period in the Subject Disposition of the ERF and the Overall Number of Baseline Participants in the RRF is synced to the Number of subjects of the Baseline Characteristics reporting groups. This causes errors on the ERF because in the ERF, the number of subjects in each arm needs to be consistent between the Subject Disposition and Baseline Characteristics sections.

In the RRF:

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In the ERF:

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Workaround:

The user can address this by changing the reporting model on the Baseline characteristics to recalculate the Number of subjects in Reporting groups in the ERF

Proposed Resolution:

ADO-15792 has been opened to resolve this in a future version of PharmaCM.

Affects Version(s):

All.

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