Prior to the inception of Copy Groups, copying objects from a library or study to another study in Oracle Clinical was a slow, tedious process in which all objects had to be copied individually. Copy Groups can contain forms, form layouts, derivation and validation procedures, completion guidelines, and help text. Copy Groups allow objects to be copied by submitting a single job. There is inherent functionality in Oracle InForm Central Designer (CD) which makes copy groups somewhat obsolete. Copying a form is as easy as pulling it into a study from a library. And all form layouts, codelists, rules (validations and derivations), and help text associated with the form are also copied into the study.
The InForm Process
While this is a similar process, it has limitations. Forms are copied individually, which can be a time-consuming process for large studies. This also means that the number of objects that can be reused becomes smaller as only the simplest of rules that are written on the form, section (within the form), or field (within the form) level are included. Object reusability is critical to shortening study development timelines. The more objects that can be built and validated once and then copied into subsequent studies with no modifications, the faster a study can be deployed into production.
With proper library management, the limitations described above can be minimized, and study development efforts can be streamlined even further. Library management guidelines vary widely by company. But they can be used to determine how libraries are organized, what is copied into the library, and when and how to use study templates.
The Approach
One approach is to store standard events in the library, which include typical standard forms for that event. For example, a typical screening event may include forms for informed consent, inclusion/exclusion criteria, physical exam, vitals, and screening status. Pulling the event into a study from the library will not only copy multiple forms and form-level objects into the study, but it will also include any complex rules written at the event level.
On a larger scale, template studies may be used to create new studies. Because studies are usually not identical, using the 60/40 rule to set up a template study should be incorporated. This allows a core set of visits like Screening, Demography, Unscheduled, and Logs to be copied in one action. These actions will also include applicable global conditions, workflow rules, and complex rules written on the study level.
Using either of these two approaches will not eliminate the need to develop and validation protocol-specific forms or rules. However, they will minimize time and effort as more standard objects can be reused.
Whatever approach is used, it is important for the Study Team and Quality Assurance to meet and develop an agreed-upon and approved validation methodology for standard objects, modifications to standard objects, and new objects to ensure that the study meets regulations and company policies and procedures.
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Perficient’s deep clinical data management experience makes us the ideal partner to support your use of Oracle InForm. We assist through a variety of key strategic capabilities, including:
- Study Build and Post-go-live Support Services
- Process Development Re-engineering
- Project Management
- User Acceptance Testing and Edit Check Specifications
If you are interested in learning more about our services and Oracle InForm, please reach out to Tammy Dutkin, Director, Clinical Data Management and EDC.
