I am very pleased to announce the availability of a new website on Scientific Data Sharing. Whether you are involved in an NIH-funded project and want to understand which sharing policies apply to your research and how to comply, or you are a researcher looking to access scientific data from NIH-affiliated repositories, this site is for you.
We have been busy over the past several months and are happy to announce you can now find helpful resources for stepped wedge group-or cluster-randomized trials (SWGRTs) and more than 15 other study designs and methodological issues on the RMR website.
Prior to submission of your application or Research Performance Progress Report (RPPR), you should re-save study records in Work in Progress applications even if you are not making changes to the study record. The Save operation updates the underlying data to match that required by the new FORMS-G.
Earlier this year, we provided an update on NLM’s efforts to modernize ClinicalTrials.gov, the world’s largest publicly accessible database of privately and publicly funded clinical trials. NLM released a request for information, hosted public webinars, and adopted a user-centered design approach intended to help ensure that modernization is responsive to user needs. These activities, together with input from the NLM Board of Regents Public Service Working Group on ClinicalTrials.gov Modernization, supported the development of beta versions of a new ClinicalTrials.gov website and components of the information submission system, also known as the Protocol Registration and Results System (PRS). The beta releases feature a modern look and feel and provide updated technology to support users.
Enhanced checks on non-compliance with clinical trial registration and reporting came into effect in eRA’s Human Subjects System on October 1 that could delay your RPPR submission if you are late on either front.
Yes. If only one aim or a small part of your project meets the NIH definition of a clinical trial, your entire NIH grant application is considered a clinical trial even if the other aims or parts of the research project are not clinical trials.
Our modernized RePORTER site features a new application programming interface (API) that makes it easier to find, access, and reuse the grants data you need.
The National Library of Medicine has embarked on several stakeholder activities as part of the roadmap for modernization that we want to highlight in this post. We will also continue to share opportunities for involvement and invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET to learn more about our modernization efforts.
We are pleased to announce that the new NIH COVID-19 website launched earlier this week. The site provides a central location for trusted, up-to-date, accurate information about NIH research and our strategic role in COVID-19 research. The site complements information made available on our COVID-19: Information for NIH Applicants and Recipients of NIH Funding webpage.
“The [NIH Inclusion Across the Lifespan] policy, and the review and reporting requirements associated with it, should help ensure that children and older adults are not inappropriately excluded from clinical studies. The policy also has the potential to provide a more robust understanding of the full spectrum of participants recruited into clinical studies.”
Together with my NIH colleagues Drs. Marie Bernard and Janine Clayton, we made this point in a 2018 JAMA opinion piece following the inaugural NIH Inclusion Across the Lifespan workshop. Fast forward, we revisited this issue at the NIH’s Inclusion Across the Lifespan 2 workshop held this past September. You can watch the videocast here. The report covering the event was posted today, and I wanted to share some of my takeaways.
