Research studies require that multiple Case Report Forms be completed per subject. At least one of those forms must be used to register or enroll a subject. Other forms are scheduled to be filled out within a specific time frame. Still, other forms occur cyclically and must be completed on a per cycle basis. Forms such as medications and adverse events are not cyclical and cannot be scheduled; thus, they must be kept in a longitudinal log. All of this comprises a subject record, and how data is added into the subject record is of critical importance.
Clinical Studio allows you to configure all of the above. It utilizes four possible ways to enter CRF data to a subject:
- Scheduled Visits
- Unscheduled, Variable and Cyclical Visits
- Log Forms
- Other Forms that do not fit the above criteria
All of the above methods are accessible from a single page called the Subject Visit/Event Page.
Clinical Studio allows you to configure a very comprehensive scheduled visit table. When configuring scheduled visits you can:
- Create an unlimited number of visit intervals
- Create a time frame for each interval that can be relative to baseline or any other interval
- Define the interval time unit from minutes to years
- Include one or more forms in the interval and define whether they are required to be completed
- Define a single point of visit or event date entry for the interval (optional)
Unscheduled, Variable and Cyclical Events
Unfortunately, not all events in a research study can be scheduled. Some events happen at random (adverse events), while other events are partially scheduled (cancer treatment cycles). Clinical Studio allows you to define those types of events and allow your site coordinators to easily enter information into the correct event.
Some forms fit naturally into a longitudinal log. A good example may be a medications form. Medications are not always scheduled and have a start and stop date that rarely falls within a single visit interval. Therefore, keeping a log of medications is very important. Clinical Studio allows you to define any form to be a log form. When that occurs you can add one or more forms to the log at any time. The log is kept by visit or event date.
For site coordinators to easily enter the correct subject information into the correct forms for the correct time frame is of critical importance to your research study. Clinical Studio allows great flexibility to be able to capture subject data.