nih dissemination plan template

Sample Dissemination Plan This project will serve as a pilot for other courses at the University of ____ and at other colleges and universities throughout the country. Such tasks include registering the CT in ClinicalTrials.gov and submitting results information to ClinicalTrials.gov. You may also want to see Investigators: Have You Checked Your ClinicalTrials.gov Records Lately? CDC UP templates are provided as guidance to be used in the absence of something more sophisticated already available to the project team. Think about what the risks are to your dissemination plan e.g. “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;. It helps ensure systematic information sharing and two-way . Investigators: Have You Checked Your ClinicalTrials.gov Records Lately? 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. The National Institutes of Health (NIH) Policy on Dissemination of NIH-funded Clinical Trial Information establishes the expectation that all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by the NIH, will ensure that their NIH-funded clinical trials are registered at, and that summary results information is submitted to, ClinicalTrials.gov for public posting 1 The … D7.7: 2nd Dissemination Plan 5 | 29 1 Executive summary This deliverable concerns the Second Dissemination Plan of STEP. NIAID Funding News, Funding News Edition: 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. 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 2. Research Engagement Plan. Investigators should consider using this template when developing the Data and Safety Monitoring Plan (DSMP) for clinical studies supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). 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. The National Cancer Institute (NCI) frequently receives requests for examples of funded grant applications. 746 0 obj <>/Filter/FlateDecode/ID[<4BCAAC9F6995B34E938FAFCB545BF120>]/Index[736 19]/Info 735 0 R/Length 65/Prev 828489/Root 737 0 R/Size 755/Type/XRef/W[1 2 1]>>stream 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 Contact your funding programme for advice. 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 � For more information, go to our Create a Resource Sharing Plan page. 1. of . Download Clinical Trial Timeline Template 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. Investigators in this proposed program recognize that promising new methods, technologies, data, software programs, and insights may arise during the course of their research. Word Version (DOC – 75 KB). VCU Health Administration. DOC. 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. The NIH is dedicated to building a diverse community in its training and employment programs. 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. Consider how your dissemination might be perceived by different groups. Which parts of your research are you allowing your recipient to use for publication? 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 More advice on dissemination. Describe the plan to engage patients and stakeholders meaningfully in all phases of the proposed research. Investigators, remember that you must comply with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information if you propose research that meets NIH’s Definition of a Clinical Trial (CT): This means that if NIH funds a CT in whole or in part that fits the requirements above, you must ensure that the CT is registered at—and summary results information is submitted to—ClinicalTrials.gov. hޜUmO�0�+����$NR MJ By having a plan to disseminate your results, you ensure that others capitalize on your research and move the knowledge forward. Research shows that employing only traditional methods is ineffective. 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. develop new partnerships. ; specifically, information on Group 1. D7.1 Communication and Dissemination Plan 4 Executive summary The present Communication and Dissemination Plan – prepared within the Dissemination-Communication-Exploitation Work Package (WP7) – will ensure that all communication and dissemination needs from various WPs and the project in general are considered and coordinated. 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. December 2017. 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). Specifically, Section 402(m) of the PHS Act stipulated that Strategic plans developed and updated by the national research institutes and national centers of NIH…shall have a common template NIH Template for IC Strategic Plans: 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. Add your own steps, milestones, and dates for a comprehensive, expansive view. Will you need to place conditions or restrictions on the recipient? Dissemination Plan of Clinical Trial. 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. This does NOT include data dissemination but should cover the following 3 … Develop a communication plan in nine steps. Select External Resources.   NIA IMPACT Dissemination Plan. The recipient institution has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements. Dissemination research Population Science/ Epidemiology. Earlier in the presentation, Lauren provided a sample template of one way you might consider organizing your dissemination plan. ‘National Institutes of Health (NIH) Strategic Plan’ outlined requirements for the NIH Strategic Plan. share solutions and know how;. Assist with dissemination activities at the yearly BRAIN PI Meeting To Apply: For more information and to apply, please direct questions to Dr. Kari Ashmont kari.ashmont@nih.gov at NINDS. The Community Voice: A Photovoice Project Identifying Barriers and Facilitators to Health and Health Care Patricia Carcaise-Edinboro, PhD. If the NIH-funded CT is an ACT under the regulation but the recipient is not the responsible party, the recipient will coordinate with the responsible party to ensure that all regulatory requirements are met. period, if funded. Preventing Disease and Note that PCORI does not expect you to undertake this work during the award . Dissemination Plan Template Language • Investigators submitting NIH FORM E must utilize dissemination plan language provided by Human Research Compliance in their application. 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). Don’t re-state that you’ll follow the policy; tell us how. The Dissemination Planning Tool was designed to help researchers create a dissemination plan that reaches beyond the traditional ways of getting the message out (e.g., peer-reviewed publications and conference presentations). H Wko _1 0000002454 00000 n Developing a dissemination plan is a key part of the collaborative research planning process. The Policy applies to all CTs initiated on or after January 18, 2017 in competing applications, even Phase I. Dissemination Plan. %%EOF We’re finding that some applicants are confusing the dissemination plan with the resource sharing plan or the public access policy. If NIH's Policy on the Dissemination of NIH-Funded Clinical Trial Information will apply to your study, this justification must also include the 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. The responsibilities of NIH grant-funded recipients conducting CTs will fall within one of three categories. For example, suppose an institution holds an investigational new drug (IND) approval and plans to subcontract qualified investigators to conduct an ACT. • 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. intellectual property issues. TEMPLATE. extend the impact;. �h`��``�h4o Ε@`��� Hs 1X$�A���8UR�-b��k�� Ob�fd``aҦx�AT1 P� 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. 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? Informed consent documents for the CT(s) will include a specific statement relating to posting of CT information and results at ClinicalTrials.gov. The nine steps in this template address the key aspects that programs should consider: 1. It offers details on the dissemination A PDF copy of this form is included below (FORMS-F). Use this free template to develop your own clinical trial timeline. influence policy and practice;. 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. DOC. 8. 1. 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. Instructions and Template for NIH R01 Grant Proposal Research Strategy. Resource Sharing and Data Dissemination Plan . Multiple PI Leadership Plan Template for NIH Grant Proposal . Data and Safety Monitoring Board Report Templates. PREFACE. Template version: v1.1 – 06/04/2020 Page . 736 0 obj <> endobj To determine whether a CT is also an ACT, go to Checklist for Evaluating Whether a Clinical Trial or Study Is an Applicable Clinical Trial. June 19, 2019 Grants & Contracts   Developing a dissemination plan is a key part of the collaborative research planning process. See more articles in this edition. 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 … 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. Get the latest public health information from CDC.   |   Get the latest research information from NIH. 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.”. This post will be available until January 31, 2021 or until filled. On this slide, you’ll find a portion of our plan and we applied this plan to the CHW evaluation. Forms and Templates TEMPLATE: Grant Submissions Plan Language, Single IRB. Do not exceed 2 pages. 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. 1.2. Dissemination Plan Template What kinds of research findings do you want to share (data, videos, images, etc.)? Author: Julie C. … If the NIH-funded CT is an ACT under the regulation and the recipient is the responsible party, the recipient will ensure that all regulatory requirements are met. Research data and documentation are stored in … The current document is an updated version of the 1st Dissemination Plan delivered on the August 2015. Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures. Download. Several investigators and their organizations agreed to let Implementation Science (IS) post excerpts of their dissemination and implementation (D&I) grant applications online. The Greater Context for Dissemination Plans. If you as the grant recipient are not the responsible party, you will not register the CT in ClinicalTrials.gov (the responsible party will). Strategic Plan Use of a Common Template to harmonize strategic plans across NIH ... across NIH The Plan . endstream endobj startxref iV�yK|�fueҴ~�?��ڈ��0���fr��瓤Ѳ. A communication plan defines the approach that a program will use to communicate with communities. Dissemination research Population Science/ Epidemiology. The University of Delaware is committed to the open and timely dissemination of research outcomes. 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. Does your research contain sensitive or protected data? Preventing Disease and Promoting Your dissemination plan doesn’t have to be long, but be sure to include enough information to assure the following: The dissemination plan will need to be more detailed for those situations in which the recipient is either not the responsible party or will not carry out the ACT itself. The results of our evaluation will be disseminated on the University's web site, which will contain a special page devoted to this NSF-sponsored project. 754 0 obj <>stream 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. 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. 0 We want to ensure that the research we fund has the maximum benefit for patients, the public and the NHS. communication. NIH Example . engage stakeholders and target groups;. ... internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. 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