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FORMS (Forms-Oriented Research Management System)

The Forms-Oriented Research Management System (FORMS) is an open-source study data management system and electronic data capture (EDC) tool geared towards academic clinical research labs. In addition to EDC, the system provides a framework for generating study reports and statistical analyses, managing study documents and media files, and sharing the outputs of research.


FORMS has several distinguishing characteristics that make it unique among clinical research management systems. Most other systems are designed for organizations that conduct pharmaceutical, industry-sponsored, FDA-monitored clinical trials. In contrast, FORMS is geared towards small-to-medium sized academic research labs that conduct a wide variety of clinical research studies (such as randomized trials; retrospective, prospective, or cross-sectional observational studies; laboratory-based or clinic-based studies; population-based studies; etc.). Whereas pharmaceutic trial protocols tend to be rather predictable. clinical science in academic settings is characterized by tremendous diversity. The design of the FORMS system reflects the complexity and diversity of academic research.


Unlike most existing systems, FORMS makes very few assumptions about study design. As just one example, most clinical trials management systems (CTMSs) include subject enrollment functionality as a standardized, core part of the system. This simplifies study setup in that the system natively handles enrollment, but it limits applicability of the system to studies involving singleton human participants. FORMS makes no such assumptions about study enrollees. Rather, study teams create whatever enrollment forms they desire, if any, and include whatever key fields they need on these forms. The FORMS systems checks other study forms, if requested, against the enrollment forms to ensure that the IDs entered represent enrolled subjects or entities. This allows complete flexibility in the enrollment process and also allows FORMS to natively handle a variety of study types, including complex family designs with multiple key fields such as those used in genetics research; studies that involve no human participants, such as animal research and meta-analyses; and studies that lack a standard enrollment procedure, such as anonymous web-based surveys.


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FORMS V0.4.0 (Alpha) can be downloaded here