Standard Rules

A Draft in a Standard Library Project may have associated Standard Rules. These rules define:

  • What should and should not appear in a Study Draft (e.g. is a Form allowed or denied in this Study)

  • The settings of object attributes and Custom Properties

These rules are associated with Project Custom Properties and are activated based on the values of those Custom Properties.

Some examples:

  1. A Standard Library defines a Vitals Form which has a question for the subject “Height”. In a neonatal study it may be more appropriate to measure the “Length” of the subject. A Standard Rule may be defined that when the Project Custom Property “Is Neonatal Study?” is set to “Yes” then the Question text for the Vitals HEIGHT question should be “Length”.

  2. A Standard Library defines a Pregnancy Test Form which is commonly used but it should never appear in studies with Male-only subjects enrolled. A Standard Rule may be defined that states when the Project Custom Property “Male Only Study?” is set to “Yes” then the Preganncy Test Form should not appear in the study.

  3. A Standard Library defines a Pharmacokinetics (PK) Form and this should always be used in Phase I studies. A Standard Rule may be defined that states that when the Project Custom Property “Study Phase” is equal to “Phase I” then the PK Form must exist in the study.

Standard Rule Types

TrialGrid defines three types of Standard Rules:

  1. Must Exist : These Rules state that an object must exist in the Study when the condition is met.

  2. Must Not Exist : These Rules state that an object must not exist in the Study when the condition is met.

  3. Value Must Be : The Rules state that an Object attribute or Custom Property must have a certain value when the condition is met.