Oracle Clinical – How to Use Study Design

Study Design in OC is the process of setting up the protocol for the study. This includes:

  • creating a record for the study
  • creating patient positions or placeholders
  • creating events or study visits
  • assigning sites or locations where data is collected
  • assigning patient positions to the site
  • study in Germany

Remember that the required study planning objects, sites and investigators must be created prior to the Design Process being completed.

It is a good idea to review all protocol and study related documentation prior to creating the study to make sure you have all of the necessary information but you can always change the Design elements at any time except for the study name.

Once the Study Design is completed, you can move to the next module: The Study Definition (creating CRFs) and develop Procedures (Edit Checks, derivations).

Tips:

  • Records for the new studies are created in the Easy Design module (Design, Studies, Easy Design)
  • Verify that the required Planning Objects exist for the study
  • In the Easy Design form create the study. Enter the study name or number, version and study description/title. Some parameters are optional. Once you click save, the system will prompt you to choose whether the study requires Pass 2 Data Entry.
  • Most Study Design parameters may be changed except fr the Study Name

Study Design Key Terms:

  • Program: Code (name) for the compound being investigated
  • Protocol: Document describing the plan of action for a study
  • Project: Code (name) for the indication under investigation
  • Study: The name for the Clinical Study
  • Organizational Unit: Code (name) for the unit responsible for the study
  • Event: Clinical Planned Event or Visits
  • Region: Code (name) of the location where the study is managed
  • Patient Positions: Identifier for a participant in a study
  • Site: A location where all or part of the study is conducted
  • Investigator: Primary researcher/clinician for the study at a site

Study Design – Events

• Study timeline is used to identify when data is collected or for tracking purposes (missing or overdue DCMs)

• Consists of one or more intervals and one or more events (visits)

• Timeline consists of intervals that are subdivided into events. By default each study is pre-populated with two defaults intervals that can be used in creating events.

• To create intervals, select the study in the Easy Design module and click on Intervals. Intervals are defined by a Phase Name, Short Name, Phase Type, Blind type (single, double, etc) and a minimum and maximum duration. The duration is used to calculate when the interval is expected to take place within the study.

• To create events, select the study in the Easy Design module and click on Events. Create all the events (visits) in which data will be collected during the course of the study. Events are defined by Event Name, Interval, Visit Number (the order o f the event is expected to occur) and minimum and maximum Offsets from the Interval Start.

• Time calculations (event offsets and interval durations) are useful only for descriptive purposes and for determining if expected CRFs are Missing or Overdue.

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