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Welcome to this introduction to NHS Human Subjects System NIH is launching a new electronic system to manage human subjects and clinical trials information This Human Subjects system replaces the Inclusion Management System IMS and will be used by grant applicants recipients and NIH staff as of June 9, 2018, The system allows principal investigators and signing officials to access and update all the human subjects and clinical trials data associated with their grants in one place You can update participant and enrollment information inform NIH of ClinicalTrialsgov registration and revise other human subjects-related information as necessary just-in-time for award or after a grant award is made The way it works is this data is initially entered by the principal investigator PI on the Human Subjects and Clinical Trials Information form in applications submitted for due dates of January 25, 2018, and beyond The applications are retrieved by NIH and once a grant number has been created NIH automatically populates the Human Subject system This data is then made available to principal investigators and signing officials through a Human Subjects link that will be available on the era Commons Status screen and the Research Performance Progress Report RPR as of June 9, 2018, For projects submitted for due dates of January 25, 2018, and beyond the system will display all the information the applicant included on the Human Subject and Clinical Trial form The system will also display additional form fields beyond those from the original grant application which may be required for progress reports For recipients who submitted their application before January 25, 2018, only the inclusion enrollment section of the displayed form is populated Grant recipients with clinical trials registered at ClinicalTrialsgov will have the option to add their ClinicalTrialsgov identifier the NCT number in the form when they have completed registering the trial Upon entry of the NCT number the system will pre-populate several form fields including study population characteristics and much of the protocol synopsis from ClinicalTrialsgov In the future users will be able to use data from the Human Subjects system to initiate and populate their ClinicalTrialsgov registration This new system allows more transparent and real time updates of human subjects data including inclusion records You may be familiar with this type of approach from managing inclusion where you can update the inclusion records directly in the system outside the application or RPR Study updates are possible through the system The most common use of this system will be for updates needed at the time of the Research Performance Progress Report RPR PRE and post award changes may include adding and updating study information updating enrollment data making off-cycle corrections or updates after application or RPR submission Converting a delayed onset study to a full study record once detailed study information is...
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