innovative data management solutions

for academic clinical research

FORMS - Continued (1)

As demonstrated in the example above, FORMS is based on a unique, “forms-first” approach to data management. It gives research teams the ability to design and upload whatever kinds of forms they need, regardless of complexity. FORMS uses these forms to inform the system about study design and structure. FORMS derives information from these user-designed forms to define the variables that are represented in the forms' fields, and it provides a built-in GUI for users to add integrity constraints, validity checks, scoring routines, etc. FORMS then adds the necessary system scripts and components to the forms to integrate them into the FORMS system and the study database.


In contrast, most existing EDC systems (e.g., CTMSs) take the opposite approach. They require users to select items from a data dictionary. The system then builds forms for its users based on these selections. This approach makes it easy to create simple, basic forms, but difficult or impossible to create more complex ones. In addition, considerable resources are required to build and maintain the data dictionary in most CTMS systems.


FORMS aims to address two competing concerns. One is the need for simplicity and the other is the need to handle complexity. This is the genesis “forms-first” approach used by FORMS. FORMS allows researchers to create whatever kinds of forms they need in order to collect data and to manage their studies. It allows researchers to easily enable EDC for these forms and integrate them into the study database. Using EDC, researchers gain real-time access to their data to help inform research operations and manage their studies. FORMS addresses the need for simplicity by making it easy to integrate simple forms into the the system for EDC and enable users to assert fine-grained control over who can see the forms, enter new form data, or read and edit existing data. To address complexity, FORMS allows form developers full access to the functionality of scripting languages and Java to create complex, dynamic forms that can then be incorporated into the system just as easily. Users can upload multiple versions of the same form. They can upload, for example, one form optimized for paperless EDC and another optimized for data entry from paper forms.


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FORMS V0.4.0 (Alpha) can be downloaded here