If you are proposing a clinical research study to NIH, you will need to specify whether your research involves an existing dataset or resource as part of the PHS Human Subjects and Clinical Trials Information Form Inclusion Enrollment Report. NIH has updated its FAQ and glossary to clarify an existing dataset or resource.
On June 25, 2024, the modernized ClinicalTrials.gov will become the singular website experience. This major milestone is part of National Library of Medicine’s multi-year ClinicalTrials.gov modernization effort, which has been guided by stakeholder engagement, input from the NLM Board of Regents Public Service Working Group, and a user-centered design approach.
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To avoid the pitfalls that inconsistent use of terms can lead to, NIH and FDA developed a glossary of terms related to clinical research that could be used to assist the research community in effectively communicating about clinical trials. NIH and FDA are most interested in hearing community feedback on the utility of the glossary in its goal of promoting effective communications. Comments will be accepted until June 24, 2024.
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In this episode of the NIH All About Grants podcast, Deysi Duque, a Senior Clinical Trials Analyst within the NIH Office of Extramural Research, talks us through the clinical trials dissemination policy, its purpose, resources, exceptions, and what recipient organizations and researchers should know to ensure compliance.
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The modernized ClinicalTrials.gov website has an updated design that is visually appealing and easy to read.
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What should researchers and recipients be aware of regarding ClinicalTrials.gov as it relates to reporting NIH grant-funded trials? Join us for this episode of the NIH All About Grants podcast to hear from Dr. Anna Fine, the Acting Director of ClinicalTrials.gov.
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In June 2023, we will reach an important milestone: replacing the current website with the modernized ClinicalTrials.gov website. This modernized site will implement the innovations we have designed based on user feedback, including an updated look and feel and improved functionality for searching, viewing, and downloading information about clinical trials.
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To assess our progress with results information submission to ClinicalTrials.gov beyond 2020, we conducted analyses of NIH-grant-funded clinical trials for which main results were due in fiscal year (FY) 2020, FY 2021 or FY 2022.
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Do you have questions about when it’s allowable to request an extension of the deadline for submitting clinical trial results information to ClinicalTrials.gov, how to request an extension, what to include, and how the requests are evaluated? A recently published resource explains all this and more.
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If you’re conducting research with human subjects, you might have questions about HHS regulations and NIH policies and how you can prepare proposals and inclusion plans. HHS and NIH experts address many of these questions, along with resources, guidance, and case studies in a 2-part webinar series focused on Human Subjects Research Policies, Clinical Trials, and Inclusion.
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