Working with Up & Previous Milestones (Clinical Operations)

Clinical Operations Vaults manage milestone pre-conditions using milestone dependencies. Prior to V16, you could order milestones by using the Up and Previous milestone types and a Sequence field.

Note: This feature is only available on Clinical Operations Vaults.

Up Milestones

An “Up” milestone is the higher-level milestone in the Study, Study Country, and Study Site hierarchy. For example, the Up milestone for Site Close is Country Close and the Up milestone for Country Close is Study Close. Each of these milestones is dependent on one another in parent-child relationships.

The following rules apply to Up milestones:

When creating a milestone at the Study level, you cannot select an Up milestone.
When creating a milestone at the Study Country level, you can only select an Up milestone pointing to its parent Study.
When creating a milestone at the Study Site level, you can only select an Up milestone pointing to its parent Study Country.

A milestone can only reference one Up milestone. However, many milestones can reference a single milestone, for example, the US Close (Study Country) milestone has one Up milestone, CC-001 Close (Study), but five different site close milestones have US Close as their Up milestone.

Previous Milestones

A “Previous” milestone refers to the order of milestones within a sequence at the Study, Study Country, or Study Site level. For example, the Previous milestone for Site Close is Site Conduct and the Previous milestone for Site Conduct is Site Start.

The following rules apply to Previous milestones:

When creating a milestone at the Study level, you can only select a Previous milestone pointing to the same Study.
When creating a milestone at the Study Country level, you can only select a Previous milestone pointing to the same Study Country.
When creating a milestone at the Study Site level, you can only select a Previous milestone pointing to the same Study Site.

A milestone can only reference one previous milestone.

If your Vault uses Up and Previous milestones, there are additional fields on your Milestone object:

Up	A higher level milestone on which this milestone is dependent.
Previous	The previous milestone in the sequence.
Sequence	Optional numerical value used to define the absolute order of two or more milestones within a sequence (previous to next). For example, you would assign the Study Start, Study Conduct, and Study Close the sequence numbers 1, 2, and 3, respectively.