6.12   Manage System Objects

System objects:

·        Are the building blocks of a trial; they include pre-made and user-created objects. Each object must be in place for the study to be published.

·        Have an upward inheritance. This means that if you change an object, those changes will happen everywhere that object exists. If you update a CodeList, for example, then every item that uses that CodeList will show the updated values.

·        Are hierarchical and relate only to the objects above them, and a higher level in the hierarchy is known as a parent. System objects are in order, from highest to the lowest in the hierarchy, as shown in the table below. Some system objects are created by the user.

For instructions for  creating, editing, copying, and deleting of system objects, see the applicable section in the table.

 

Note: You can also copy system objects from an existing  trial. (See Copy Objects from a Trial.)

 

System Object (shown in hierarchal order from highest to lowest)

Description

Trial

A trial represents the study in TrialMaster that contains everything involved with the particular trial.

Sites

Types of sites in a trial are a collection of patient types that are associated with a particular site. Sites are placed into trials. (See Manage Sites.)

Patients

Types of patients and are a collection of visit types in which the patient participates. Patients are placed into sites. (See Manage Patients.)

Visits

A visit is a collection of forms that are to be filled out on that particular visit. For example, during a screening visit, medical history and eligibility criteria are collected. Visits are placed into patients. (See Manage Visits.)

Forms

A collection of Groups that appear together in TrialMaster, for example Demography and Race. Forms are placed into visits. (See Manage Forms.)

Groups

A collection of Items that appear together on a form. Items that appear in groups are related, like the questions relating to vital signs. Groups are placed into forms. (See Manage Groups.)

Items

Typically make up the questions in a trial. There are various control types which change how an Item looks and behaves. Items are placed into groups. (See Manage Items.)

CodeList

CodeLists are the smallest building blocks of a trial. They are a list of coded values that populate various item control types like a Combo Box or List Box. CodeLists are associated with items. (See Manage CodeLists.)

 

TrialBuilder provides "optimist locking" whenever you work on an object, so that you don’t overwrite others' changes by mistake.

In the following example, User B will not be able to save the Form. User B will have to re-query and do the changes again.

 

Note: When attempting to save an object, the object can only be saved if referenced objects have not been deleted.