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Oracle Clinical – Planning a study

Planning a study in Oracle Clinical involves several steps, including study design, setup, and configuration. Here are the steps to help you plan a study in Oracle Clinical:

  1. Determine the study design: Determine the study design and parameters, including the type of study, number of patients, study duration, and data collection methods.
  2. Define the study forms: Define the study forms, including the questions and data fields that will be used to collect the data. You can use predefined forms, create new forms, or customize existing forms to meet the needs of your study.
  3. Configure the EDC system: Set up the electronic data capture (EDC) system, including the data validation rules and quality control checks that will be used to ensure the accuracy and completeness of the data.
  4. Define the study workflows: Define the study workflows, including the steps involved in the data collection and management process.
  5. Set up the study environment: Set up the study environment, including the study-specific settings, user roles and access, and study-specific security measures.
  6. Test the study setup: Test the study setup to ensure that everything is working as expected and that the data collection and management process is efficient and effective.
  7. Launch the study: Launch the study and start collecting data. Monitor the study progress and make any necessary adjustments as the study progresses.

These are the basic steps to help you plan a study in Oracle Clinical. The software provides a range of tools and templates to help you streamline the study planning process and ensure that your study is configured to meet your specific needs.

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