The following table displays terms that are frequently used within OpenClinica.
| Question | Answer |
|---|---|
| What is a study? | A study is a collection of Forms and Events that contain participant data. |
| What is a participant? | A participant (or a subject) is a person who provides data for the study. If the Participate Module is activated, participants can enter data. If the Randomize Module is activated, participants can randomly assign groups, such as placebo and non-placebo without the bias of demographics, sex, gender, age, etc. |
| What is an Event? | Every Event has at least one Form. An Event can be visit-based, a scheduled occurence, or common, an unscheduled occurence. Events can common events can also be repeating or non-repeating. Examples: Visit-Based: One Month Followup Common Repeating: Adverse Event Common Non-Repeating: Termination |
| What is a Form? | A Form (or CRF) is an electronic record of participant data. Each Event has at least one Form. You can enter data into a Form, depending on your access. Forms can have conditional fields that only appear as a result of selecting specific responses or include calculations. Data Managers create Forms in Study Designer. If the Participate module is activated, they can make the Form a Participate Form, which allows participants to enter data from their device. |
| What is Study Designer? | Study Designer is where Data Managers create Events and Forms. |
| What is Study Runner? | Study Runner is the application for using the study, either in Test or Production. Depending on acces, you can view/enter data, create queries, verify, import data, extract data, etc. |