What goes wrong in a 68-day study build

The 68-day number comes from an ACRP study on database build cycle times. Across six mid-size sponsors, the time breaks down as: Protocol interpretation 8-12 days, CRF design 6-10 days, Internal review 5-8 days, EDC build 8-14 days, UAT 7-12 days, SDTM mapping documentation 6-10 days, DMP production 4-8 days, and pure waiting 8-16 days.

The DM team is actively working for roughly 30-35 days of the 68. The other 33-38 days are review waiting time, revision cycles, and coordination overhead. Almost all of the active DM time is translation work.