Study Lock

Susanne Prokscha · 2024

This chapter describes the activities for study locks. These include both final database locks and locks for interim analyses. The core requirements for lock apply to both cases, but interim locks where the database is still active will challenge the study team. A data extract or snapshot plan supports all kinds of targeted data entry and cleaning activities that prepare data for analysis, including interim and final locks. Refer to Appendix B for an example of an extract plan and refer to Chapter 16 for other post-lock activities including unlocks.

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