We have successful enrollment of a participant in a trial under different ARMCD due to multiple protocol amendments. Subject was randomized first under Placebo and successfully completed protocol required procedures. Later study had become open-label and subject has been enrolled into Active drug ARM. As per FDA technical conformance guide,
For subjects with multiple enrollments within a single study, the primary enrollment should be submitted in DM. Additional enrollments should be included in a custom domain with a similar structure to DM. Clarifying statements in the RG would be helpful.
Hence, the question is Does primary enrollment means first enrollment in study or latest enrollment in study? Since this subject will have RFST/RFEN/RFXST/RFXEN populated for both ARMCDs (Placebo as well as Active Drug), is there any precedence for FDA submission for such scenarios or any clarifications regarding the issue?
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Hi team,
We have successful enrollment of a participant in a trial under different ARMCD due to multiple protocol amendments. Subject was randomized first under Placebo and successfully completed protocol required procedures. Later study had become open-label and subject has been enrolled into Active drug ARM. As per FDA technical conformance guide,
For subjects with multiple enrollments within a single study, the primary enrollment should be submitted in DM. Additional enrollments should be included in a custom domain with a similar structure to DM. Clarifying statements in the RG would be helpful.
Hence, the question is Does primary enrollment means first enrollment in study or latest enrollment in study? Since this subject will have RFST/RFEN/RFXST/RFXEN populated for both ARMCDs (Placebo as well as Active Drug), is there any precedence for FDA submission for such scenarios or any clarifications regarding the issue?