Publishing Clinical Trial Protocols on ClinicalTrials.gov

Publishing Clinical Trial Protocols on ClinicalTrials.gov

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The ClinicalTrials.gov web site is a central web location by the United States FDA for maintaining and publishing clinical trial protocol and study result information in a web-based format. ClinicalTrials.gov provides a web interface for entering clinical trial protocol data information as well as an XML upload/download and import/export capability for managing clinical trial protocol data using outside methods, software applications, and products, such as the visual ClinicalTrials.gov XML editor, Clinical Trial Submit.

The ClinicalTrials.gov Protocol Registration System (PRS) contains a set of web-enabled fields for entering data specific to clinical study protocol detailed description information and, if applicable for completed studies, clinical study results. Both protocol registration data and study results may be imported and exported via XML to and from the system, allowing for modification and processing of clinical trial study protocol record information by software applications, web frameworks, and other computer processes.

To begin using the ClinicalTrials.gov PRS system, an organization may fill out application information to apply for system access. Once reviewed and completed, clinical trial protocol data and study results may be entered for processing.

Records maintained on the ClinicalTrials.gov PRS system web site are published and made public and searchable via XML in the ClinicalTrials.gov search engine for viewing by the public.