Configurations, terms, and concepts

Configurations

Configurations are either custom or predefined templates (processes) that define:

Documents, contracts, and submission items (artifacts) needed for each study country and study site
Key dates (milestones) to track in a study
Activities required to process each document, contract, or submission (lifecycles)
Permissions (roles) that a team member must have to perform each activity
Activities that must be complete before other activities begin (dependencies)

When deployed to Oracle Site Activate and applied to a study, a configuration guides the study’s team members to complete and track document, submission, and other activities based on your organization’s standard business practices as well as country-specific requirements.

Configuration development is a team effort

Configuration review and development will involve multiple stakeholders including members of the study team and an assigned configuration lead. Study team members may review available configurations to select a baseline and evaluate changes needed (for example, to ensure the proper artifacts exist at the country level). A representative from Oracle may also take part in certain configuration reviews or specific update types, like configuring lifecycles.

Business role permissions granted to your individual Oracle Site Activate user account will determine your ability to view or change the various attributes of a configuration. As a lead configuration designer user, you:

Understand your organization’s baseline configurations and change control process
Can communicate how configuration changes will affect the project team
Have used and understand Activate features and can evaluate the pros and cons of modeling configurations to support current processes
Are a stakeholder who can make decisions as needed to deploy configurations that support overall business objectives

Key terms and concepts

The table below defines some key terms to help you better understand how to manage configurations.

Term	Definition
Artifact	Artifacts are distinct items like documents, contracts, packages, and submissions that study team members track and complete in Oracle Site Activate. Use Configuration Designer to add, change, or delete artifacts.
Collection	Groups of artifact workflows, also known as scenarios, which are managed together. Collections make it easier to automatically create groups of related artifacts. Oracle provides default collections of study, study country, principle investigator, and staff items.
Lifecycle	Activities your organization uses to track artifacts. To get you started, we offer a variety of lifecycles based on known submission requirements and common industry practices for documents, contracts, packages, and submissions in a wide range of countries. Artifact lifecycles can also have decision options that cause the collection to branch based on the choices your team members make.
Dependencies	As team members complete activities, Oracle Site Activate alerts the individual(s) assigned to perform the next activity. Oracle Site Activate allows tasks to begin after the completion of all prerequisite tasks.
Trigger	An event that causes a collection (see above) to run. Oracle Site Activate collections can automatically run when certain triggers happen. For example, a trigger event could be when a team member adds a study country, adds a staff member, or changes the investigator.
Category	Groups of document, contract, submission, and package activities. These help you have different regional or project-specific processes but track their status globally.
Milestone	An action or event that marks a significant change or stage in a development. You can define and track as many milestones as you want in reports. Up to 50 milestones show on study country and site timelines. Oracle Site Activate milestone timelines show the baseline (original projection), planned (reprojected), and actual dates. Define study country and site milestones that your organization tracks globally.
Role	Role assignment controls who can perform activities in Oracle Site Activate. As you work with configurations, you can specify which role can carry out a task. Study team members have one or more role assignments that grant them permission or the responsibility to perform activities.