736 0 obj <> endobj Template version: v1.1 – 06/04/2020 Page . The Greater Context for Dissemination Plans. Additionally, National Institutes of Health (NIH) has specific requirements for sharing data: see NIH Public Access Policy Back to NSF: proposals to the NSF can satisfy these expectations by including the supplementary “Data Management Plan” that describes how the proposal will conform to NSF policy on the dissemination and sharing of research results. Dissemination Plan Template What kinds of research findings do you want to share (data, videos, images, etc.)? communication. However, since compliance with 4.1.3 Clinical Trials Registration and Reporting in ClinicalTrials.gov Requirement will be a term and condition of your award, your application needs to explain how you will coordinate with the responsible party to ensure the CT is registered and the results are submitted on time. This post will be available until January 31, 2021 or until filled. Note on multiple delayed onset studies: If you are including more than one delayed onset study in any given delayed onset study entry, address all the included studies in a single justification attachment. Preventing Disease and Promoting • The dissemination plan should contain ‐ Type and number of dissemination products ... • Dissemination plan template • Publication standards and authorship guidelines ... NIH requires that data be retained for 3 years after study completion. As IND holder, the institution is the “responsible party.” In the dissemination plan, the applicant must describe how those subcontracted investigators will transmit relevant information to the institution so that it can register and report results to ClinicalTrials.gov in a timely manner. As part of their applications or proposals, applicants and offerors seeking NIH funding will be required to submit a plan for the dissemination of NIH-funded clinical trial information that will address how the expectations of this policy will be met. DOC. June 19, 2019 Which parts of your research are you allowing your recipient to use for publication? %%EOF Which category depends on whether, under 42 CFR Part 11 (the regulation), the CT is also an "applicable clinical trial" (ACT) and whether the recipient or its designated investigator is the “responsible party.”. Note that PCORI does not expect you to undertake this work during the award . Recruitment and Retention Plan’ template for investigators who will be using an existing dataset (i.e., study will have no participants and therefore no recruitment/retention activities). The dissemination plan has you describe how you will ensure compliance with the requirements of ClinicalTrials.gov, specifically by providing the information listed in 4.7 Dissemination Plan in section G.500-PHS Human Subjects and Clinical Trials Information Dissemination Plan. Also keep in mind that as part of your grant application, you are required to submit a plan for disseminating NIH-funded CT information that addresses how you will meet the expectations of this Policy. We expand on that aspect below. Each template includes content commonly used in such a document, boilerplate text, and instructions to the author to assist them in completing and adapting the template for use on their project. The University of Delaware is committed to the open and timely dissemination of research outcomes. Grants & Contracts   endstream endobj 737 0 obj <>/Metadata 60 0 R/OCProperties<>/OCGs[747 0 R]>>/Outlines 87 0 R/PageLayout/SinglePage/Pages 732 0 R/StructTreeRoot 118 0 R/Type/Catalog>> endobj 738 0 obj <>/Font<>/Properties<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Trans 753 0 R/Type/Page>> endobj 739 0 obj <>stream h�b```f``�"�3D@��9�04���\��\`X� ����L����387��U���Z����Ȕv�a��H�L1M�� Bػue��5Md���F�i;DV&�&0�w0Y00�wt0�s( &Q � If the NIH-funded CT is not an ACT under the regulation, the recipient will be responsible for carrying out the tasks and meeting the timelines described in the regulation. Investigators: Have You Checked Your ClinicalTrials.gov Records Lately? Preparing the NIH Human Subjects Documents Effective January 2018, all grants proposing human subjects research must include a Human Subjects and Clinical Trials Information form. influence policy and practice;. The National Cancer Institute (NCI) frequently receives requests for examples of funded grant applications. If you aren’t sure which data elements are required, know that clinical trial registration information, summary results information, and the timeframe for registration and results reporting under the Policy are the same as 42 CFR Part 11 (the regulation). In a competing application submitted on or after January 18, 2017, To support the conduct of a clinical trial that is initiated on or after that date. The nine steps in this template address the key aspects that programs should consider: 1. Download Clinical Trial Timeline Template That you, the applicant, will ensure that the CT (or CTs) under the award are registered and summary results information is submitted to ClinicalTrials.gov, in the timelines stated in the Dissemination Policy. Download. December 2017. NIH’s Public Access Policy requires NIH-funded investigators to submit final peer-reviewed manuscripts to a public archive of research publications and to show evidence of compliance with the public access policy in applications, proposals, and progress reports. ; specifically, information on Group 1. A PDF copy of this form is included below (FORMS-F). For official instructions, including what to do when there are multiple CTs, go to 4.7 Dissemination Plan in section G.500-PHS Human Subjects and Clinical Trials Information. Does your research contain sensitive or protected data?   The dissemination plan has you describe how you will ensure compliance with the requirements of ClinicalTrials.gov, specifically by providing the information listed in 4.7 Dissemination Plan in section G.500-PHS Human Subjects and Clinical Trials Information of FORMS-E. Think about what the risks are to your dissemination plan e.g. We want to ensure that the research we fund has the maximum benefit for patients, the public and the NHS. Although the decision makers and researchers working together won’t know the results of the research until it’s completed, working through an initial dissemination plan can help your team focus the project and �h`��``�h4o Ε@`��� Hs 1X$�A���8UR�-b��k�� Ob�fd``aҦx�AT1 P� To clarify, the resource sharing plan is for describing how you will share model organisms, final research data, or other information subject to the NIH Genomic Data Sharing policy. This sample language has been developed for use in the “Human Subjects” section of grant applications where the use of a Single IRB is required. However, within the PHS Human Subjects and Clinical Trials Information Form, a dissemination plan is required if your study is a clinical trial in order to describe the plan for the dissemination of NIH-funded clinical trial information and address how you will meet NIH’s policy on the dissemination of NIH-funded clinical trial information. 8. engage stakeholders and target groups;. Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures. DOC. Dissemination Plan Template Language • Investigators submitting NIH FORM E must utilize dissemination plan language provided by Human Research Compliance in their application. Several investigators and their organizations agreed to let Implementation Science (IS) post excerpts of their dissemination and implementation (D&I) grant applications online. endstream endobj startxref CDC UP templates are provided as guidance to be used in the absence of something more sophisticated already available to the project team. H Wko _1 0000002454 00000 n Developing a dissemination plan is a key part of the collaborative research planning process. The current document is an updated version of the 1st Dissemination Plan delivered on the August 2015. 1. the latest public health information from CDC, Autoimmune Lymphoproliferative Syndrome (ALPS), Characterizing Food Allergy & Addressing Related Disorders, Prevention, Treatment & Control Strategies, Strategic Partnerships & Research Capacity, Primary Immune Deficiency Diseases (PIDDs), Partnership for Access to Clinical Trials (PACT), Division of Allergy, Immunology, and Transplantation, Division of Microbiology and Infectious Diseases, Dr. Joseph Kinyoun The Indispensable Forgotten Man, Dr. Joseph Kinyoun: Selected Bibliography, Baricitinib Plus Remdesivir Shows Promise for Treating COVID-19, NIH Announces Restructured HIV Clinical Trials Networks, G.500-PHS Human Subjects and Clinical Trials Information, NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, timeframe for registration and results reporting, Checklist for Evaluating Whether a Clinical Trial or Study Is an Applicable Clinical Trial, 4.1.3 Clinical Trials Registration and Reporting in ClinicalTrials.gov Requirement, Section 4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. For more information, go to our Create a Resource Sharing Plan page. “It is fundamental that your dissemination plan is realistic and relevant to the size and scope of the project that you plan to deliver.” Keep in mind that dissemination is needed to: raise awareness;. ‘National Institutes of Health (NIH) Strategic Plan’ outlined requirements for the NIH Strategic Plan. Dissemination research Population Science/ Epidemiology. VCU Health Administration. Use this free template to develop your own clinical trial timeline. NIH Example . Dissemination Plan for NIH Clinical Trials: HRPP template language NIH proposals for clinical trials now require additional information, including a dissemination plan that describes how the investigator will fulfill ClinicalTrials.gov registration and reporting requirements for NIH-funded clinical trials. You may also want to see Investigators: Have You Checked Your ClinicalTrials.gov Records Lately? Dissemination Plan of Clinical Trial. Another main element of NIDA’s mission is ensuring the effective translation, implementation, and dissemination of scientific research findings to improve the prevention and treatment of substance use disorders and enhance public awareness of addiction as a brain disorder. aLk��2&!>x��Z�I������MI�R�N��{���QF� &aӀ��'�`$`��x�G8c$| �>9?�c�T'�,�M��f�t��R�fxEo[9W���tY������o������*���Y���q�,eI� ���l,7��4O�i֊�#�>�R.�哹ʍ4����+����&�������!�r�3? Templates for investigators, study staff, data managers, study statisticians and others involved in submitting periodic reports to NIAMS-appointed, independent monitoring bodies (e.g., an independent Data … D7.7: 2nd Dissemination Plan 5 | 29 1 Executive summary This deliverable concerns the Second Dissemination Plan of STEP. For complete details on the NIH Dissemination Policy, read the Guide notice link in the introduction and Section 4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information in the NIH Grants Policy Statement. 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